The drug did not reach the expected endpoint according to the company. It is the newest disappointment in a string of flops in this niche R&D field. The company is now planning to assess the full records before it can point out its next steps.

While the treatment BYM338 reins in myostatin, investigators have indicated that it has added probable for cachexia, COPD and sarcopenia having hopped on board of MorphoSys’ antibody fact-finding platform.

Well, as Novartis mourns over the setback, Scholar Rock, the Cambridge, MA-based biotech is treating it as an added advantage having recorded a $36 million B round for its new and possibly better-quality myostatin blocker. Scholar Rock’s aim was to facilitate the building of muscle in patients who are distressed with muscle atrophy.

But according to Peter Ganz at UCSF who has carried out an assessment of myostatin in preclinical studies says that its lesser levels of that protein reduced levels of GDF11 as well as levels of that protein. All these were associated with the thickening of heart muscles failing of the  heart. However, the said knocking down myostatin in order to build muscle to fight wasting may not be a simple matter and could turn out to be very dangerous.

The hardship in knocking down myostatin was backed up by Atara–an Amgen, Inc. (NASDAQ:AMGN) spinoff after the failure of its scientific candidate PINTA 745 flopped  a Phase II study for protein-energy wasting. The biotech has since halted its development efforts and has since switched focus to cancer.

Another myostatin drug with big visions to fight muscle wasting is ACE-031. However, its clinical work which was in the hands of Acceleron Pharma Inc (NASDAQ:XLRN) and Shire PLC (ADR) (NASDAQ:SHPG) was also halted.

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In its aim to grow its global production network, and for the 15 years,   Novo has capitalized on more than €300 million in what the CEO Lars Rebien Sorensen refers to as one of the company’s most important strategic production sites. The expansion has been a significant anticipation of growth in demand for its insulin and other products, being the worldwide diabetes epidemic burgeons.

The new project is expected to be complete in about three years it becomes part of Nova’s market whose largest share is in the US and accounts for more than half its sales. The 833,000-square-foot project in Clayton NC (worth $1.8 billion), kicked off last month and will be next to to Novo’s current 457,000-square-foot manufacturing facilities.  Its completion will add about 700 jobs to its site in Clayton which will manufacture the active ingredients for a daily oral treatment for Type 2 diabetes besides current and future Novo insulin products.

The drug maker made known the Clayton buildup which was part of $2 billion expansion that included a new production facility in Malov, Denmark. It is from this facility that tableting and packaging of the oral diabetes med will done and will also envelope other oral meds developed by Nova.

The investment of $200 million in Malov will create 100 new jobs which is a plus for the company and a clear sign of its expansion plans. It is already having a presence in Russia having opened a plant there last year and plans are under way a facility in Iran.

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Between 2001 and 2004, GSK paid around $72 million to a host of generic companies to defer retailing their copycat descriptions of its medicines. The move would give lee way to GSK to keep selling its own which is, much pricier than the state-run NHS.

Well, GSK did take kindly the multimillion-pound penalty levied on it by the country’s market overseer. Among other things the drug maker outline on its appeal is that CMA had blundered in concluding about the GSK’s conduct. CMA has said that GSK’s conduct was “objectively justified.”  Apparently, GSK was not complaining about being fine, but the main concern was that the amount was excessive.

The company is now looking up to a tribunal whose ate is not agreed upon yet and which is expected to intervene into the reduction of the fine imposed on GSK. Better still GSK will ask the tribunal to compel CMA to pay the costs incurred in the appeal.

Some of the companies mentioned in the GSK saga include Germany’s Merck & Co., Inc. (NYSE:MRK) and Generics UK among others and will also part with around $7 million a decision they will not adhere to and have since appealed.

GSK is not the only victim of penalties from the CMA. Pfizer Inc. (NYSE:PFE) has had its share too of £10,000 penalty having being accused of not submitting to the regulator a set of important documents. The documents would lead to the clearing of this drug maker from any wrongdoing in a separate case which purported that it has played a role in hiking the price tag of its now off-patent epilepsy drug Epanutin (phenytoin sodium) in the U.K.

It is not off the hook yet and if found guilty, it will incur a 10% of its total $48.9 billion 2015 revenue in penalties. The fine would be bigger than the record $3 billion charge on GSK by the U.S. Justice Department in 2012 in a case that was relate to “marketing abuses,”

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Of the 8 patients, 2 high dose patients had increasing levels of Factor VIII which were above 50%. 5 out of 6 high dose patients had Factor VIII levels above 5%. Well, the raising of levels in patients with the condition is highly recommended because it helps in managing it. Besides, those with the condition can hardly produce enough functional Factor VIII that prevents bleeding.

A single dose of BMN 270 was administered to the 8 patients with severe hemophilia A with 6 of them being treated to the highest dose of 6 x 1013 vg/kg. Patients at the highest dose experienced increasing Factor VIII activity levels according to BioMarin’s last observation of between 4% and 60%.

The efficacy of the drug appeared strong. However, there was a slight safety apprehension given that ALT liver enzyme levels increased across some patients. Nevertheless, the administration of prophylactic corticosteroid therapy enabled the drop-down of the levels.

A couple of drugs for the hemophilia A and B are now available in the market the likes of Biogen Inc (NASDAQ:BIIB) Factor IX Alprolix and other meds from Baxalta Inc (NYSE:BXLT) and Novo Nordisk A/S (ADR) (NYSE:NVO)

However, there are other companies seeking the gene therapy space for the condition. Massachusetts-based Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) is one of the companies that is working on a cutting-edge gene therapy.

Well, even though BMN 270 is one of a new set of trial drugs intended to address the underlying genetic defect, it has already received an orphan drug designation in Europe from the FDA. It is now undertaking the Phase III design groundwork and high volume manufacturing plans. But it has not been all well for the company having disappointed some analysts with its recent readout. Before then, it had received a rejection of its Duchenne muscular dystrophy drug, a disappointment that raises eyebrows of the company’s credibility on R&D.

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Second Genome Co-founded by serial West Coast biotech entrepreneur Corey Goodman is undergoing its Phase I program for its lead therapy, SGM-1019 whose intention is to explore possibilities of an inflammatory bowel disease pathway. For the longest time possible, the South San Francisco-based Second Genome has been on a mission to build a microbiome platform that scans the enormous ecosystem of the gut which would aid in identifying disease triggers.

And while on this journey, it has been able to win collaborations with Pfizer and Johnson & Johnson (NYSE:JNJ). However, being among the small and growing biotechs, its efforts to scale up were heightened by Evotec which is giving biotech a chance to grow.

According to CEO Peter DiLaura, it’s never as straight and predictable as it looks during the early stages. Well, there has been a lot to look up to for the last three years with so many prospects to have the drug developed both in-house and alongside Big Pharma partners.

Well, there is much more that DiLaura is not letting out. For example, there will be an addition of programs into the pipeline even though not within a set timeline. However there is a lot of optimism and The CE chooses to remain opportunistic especially because of the current changing landscape biotech.

Many more microbiome startups have continued to populate the biotech field in the recent past the likes of France’s Enterome which is progressing pretty first and Cambridge, MA-based Seres Health whose 2015 IPO raised $134 million.

And while at this, Carole Nuechterlein, head of Roche Venture Fund together with the executive director of Pfizer Venture Investments, Elaine Jones are joining the directorship helm of Second Genome.

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Relieve Genetics is one of the startups aiming at gaining a breakthrough, non-opioid gene therapy approach for neuropathic pain. The therapy is expected to substitute the symptomatic treatments with those whose attacks whose pain is underlying.

Intrexon’s RheoSwitch technology will come in handy for the delivery of gene regulation. It will help in the coordination of timing and dose of an oral activator ligand. Intrexon Senior Vice President Samuel Broder says that Neuropathic pain is one of the unmet needs in today’s healthcare.

Hence, the collaboration with Relieve Genetics will be so significant in materially impacting on the lives of dozens of patients who are in frantic need of relief from pain. It will be an opportunity for them to walk away from the rebellious the likes of opiates.

Exotech Bio is the other startup that Intrexon is putting on board. The company will employ the use of Intrexon’s exosome-based technology that will enable the delivery of RNA to treat cancer. Well, this is all new for Intrexon but nevertheless, its experience in designing of vectors and other genetic carriers all which can be used vectors and other genetic carriers will facilitate in gaining a breakthrough.

According to Broder, there is a promise in Intrexon’s work in engineering complex miRNAs. The promise is within the exosome-based platform that will help in addressing certain cancers where conventional approaches have failed.

Speculations are high that Intrexon may have received upfront payments. However, the company has remained tight-lipped on this. Nevertheless, all that is clear is that the company will take home up to 25% technology access fee, R&D reimbursement as well as potential milestones as stipulated in the terms of the exclusive channel collaborations.

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The company has outlined is the new formulation could also be effective in adults who are having difficulties in swallowing or opening capsules.

Speaking about the drug, head of Shire’s Neuroscience, Ophthalmics, Perry Sternberg, Vyvanse chewable tablets are more or fewer alternatives for patients who may prefer taking medication in the described forms. In any case, patients’ satisfaction is within Shire’s mission and will o anything to achieve it. The drug is currently in use in the treatment of ADHD in patients with an inclination of more than six years. Nevertheless, it can also be used for treating moderate to severe binge eating in adults even though there no clear details linking the drug to weight loss.

That said, Sternberg has since confirmed the company’s keenness of a positive response from the FDA’s review of its application. The company used two studies which were cited in its application. The approval by the FDA will permit patients to ingest the medication once daily with morning being of more inclination. Well, instructions outline on the medication guide should be kept to the tab.

The company seems to be going places even if the drug has not gained approval in any country. It has been looking at an anticipate merger with Baxalta Inc (NYSE:BXLT). Well, Shire CEO Flemming Ornskov is optimistic that the merger deal will yield goo results by the middle of the year.

However, word has it that Pfizer Inc. (NYSE:PFE) had cancelled its merger with Allergan plc Ordinary Shares (NYSE:AGN) as a result of a U.S. Treasury tax crackdown.

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Cobiprostone had botched in showing any meaningful improvement of heartburn symptoms for proton pump inhibitor-resistant non-erosive reflux disease (NERD). The study failed to keep to the primary endpoint Investors were not pleased with the news of the 20% drop of Sucampo’s stock and reacted sharply to the same.

However, a statement from Rockville, MD-based Sucampo CSO Peter Kiener indicated that the data did not show any certainty of cobiprostone having been well-tolerated. In any case, it was consistent with the earlier Phase I studies. That said, Kiener confirms that plans are still underway to continue with the development of cobiprostone in the ongoing Phase IIa study.

The development plan will also accommodate a futility study on the current trial in the second half of this year.

Phase 2a study in NERD/sGERD was randomized, double-blinded, multicenter a placebo-controlled. It aim was to investigated the safety and efficacy of cobiprostone or placebo whose administration was three times daily over eight weeks in 153 NERD and sGERD patients.

Basically, Cobiprostone works to stimulate and protect the mucosal barrier function having been the locally acting chloride channel activator that it is. However, it is currently under development for the prevention of oral mucositis in patients’ grieving with head and neck cancer and are probably able to access simultaneous radiation and chemotherapy.

Sucampo has two marketed products; AMITIZA and RESCULA whereby the former is its lead product while the latter is a pipeline of product candidates in clinical development. The company acknowledges that there are major unmet medical needs of patients worldwide. And that said it is currently laying its focus on the development and commercialization of medicines that will facilitate the accomplishment of these unmet needs.

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The drug, a dual GLP1-glucagon receptor agonist produced HbA1c improvements earlier in February according to Transition and which were more or less similar to those from Byetta.

The news from Lilly was not easy for Transition’s share prices which were taken steps backwards by the plunging plunged 26% which would also impact in the company’s penny stock territory. Apparently, this is not the first time Transition is receiving bad news in a span of 9 months and the investors lost all the optimism.

The failure of its Phase II/III study of its lead therapy–ELND005 in June was not good news as it led to the tanking of the share price. The therapy which had been designed to address agitation in Alzheimer’s patients I not reach its expected primary endpoint. Nevertheless, Transition was quick to highlight the drug’s activity in patient subsets with its highlighted subsequent analysis.

Well, according to Dr. Tony Cruz, chairman and chief executive officer of Transition, TT401 is worth being ranked as a first-to-market product. And being a leader in this new class of therapies it has such a unique opportunity which has a segregated mechanism and activity from the currently sanctioned diabetes therapeutics.

Nevertheless, Transition still needs help in moving forward even though it claims that it has a pipeline worth boasting about.

The truth is that Alzheimer’s and diabetes are a big expense in their late-stage studies for any prospective therapy.

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As a result of these unfolding, J&J’s Janssen unit has been asked by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) to submit additional information. The information will help in unraveling the mystery as of whether Invokana had anything to do with lower-limb amputations.

The probe by the Regulators was necessitated by the ongoing clinical trial, Canagliflozin Cardiovascular Assessment Study (CANVAS) which is pursuing about 4,000 Type 2 diabetes patients. The patients have received the drug’s administration either in 100 mg or 300 mg daily dose of Invokana or a placebo.

The study revealed that in every 1,000 patient-years for the 100 mg dose there were 7 cases of lower-limb amputation while in every lower-limb amputation, there were 5 similar cases.

Nevertheless, Janssen CMO Dr. Amrit Ray says that for the best interest if the patient, all new information on safety is taken seriously, respected hence the company will adhere to recommendation of the Independent Data Monitoring Committee.

Well, AstraZeneca plc (ADR) (NYSE:AZN) and Eli Lilly and Co (NYSE:LLY) have also been spotted by the PRAC and maybe asked to provide more data on Farxig and Boehringer Ingelheim’s Jardiance. It is likely that PRAC could call for an extended scope of review.

Invokana’s safety probe by EMA is such a setback owing to the fact that the drug is competing in a crowded SGLT2 field. It is only last year when the drug’s label received a strengthened warning from the FDA which presented information about bone mineral density and an amplified threat of bone fractures.

But all is not lost for J&J according to some analysis. The company is likely to benefit from Lilly and Boehringer’s new cardiac data which will give Invokana increased sales. J&J CFO Dominic Caruso agrees to this while citing that there’s a positive effect resulting from cardiovascular data share by Lilly

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Word has it that the California biotech embraced likings for AstraZeneca after the Anglo-Swedish drugmaker made a kill of a £7 billion ($9.9 billion) bid. On the other hand, Sanofi is said to be considering to go hostile after being repulsed by Medivation. According to news from anonymous sources, Sanofi had not met Medivation’s threshold of a higher bid hence the reason for rejection.

Various Big Pharma’s the likes of Gilead Sciences, Inc. (NASDAQ:GILD) and Amgen, Inc. (NASDAQ:AMGN) have expressed their interest even though none of them has reacted to the rumors. However, a deal with AstraZeneca could make sense given the fact that it has suffered from late-stage failures in its pipeline over the years. Furthermore, its CEO Pascal Soriot is optimistic that the Company will regain its glory with double revenue by the end of the decade.

Sanofi has not been left behind either having taken up the second evolution of its pipeline. The outsourcing of more of its R&D and the trimming of its oncology research had led to the signing of deals between the French pharma and its biotech arm Genzyme.

Meanwhile, AstraZeneca is not a stranger to major M&A deals. In 2014, it almost got into a $118 billion with Pfizer Inc. (NYSE:PFE) before politics of tax inversions wrecked the takeover. Xtandi is also an attractive blockbuster and would easily give any purchaser an immediate return given the long-term prospects of its pipeline which consists of the late-stage breast cancer drug talazoparib.

However, the ongoing pricing debate in the U.S has put Medivation in the spotlight for its $129,000 price tag for Xtandi. Apparently, Presidential hopeful Bernie Sanders has vowed to invalidate the drug’s patent which will allow the entry of cheaper generics into the market.

Medivation is now facing a potential acquisition following a drop of its shares which has been caused by the acquisition.

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However, the fund which will be independently managed of the genomics giant takes on board a model significant of the freedom enjoyed by GV formerly known as Google Ventures. Well, it will pursue investments in early stage companies’ interested in new uses for nucleic acid sequencing. It is also on a higher level in that it more of an arm’s length relationship to Illumina than GV does to Alphabet Inc (NASDAQ:GOOG).

Illumina will take the majority limited partner in the fund even though there are plans to encompass other investors into the initiative which according to Illumina CEO Jay Flatley will be advantageous in that it will be away of supporting the fund financially an intellectually.

Nonetheless, internal venture investing has worked well for Illumina under Naclerio’s leadership. It has resulted to the provision of calculated insights and networks to key technologies and channels within the industry.

Jay Flatley, Chairman and Chief Executive Officer for Illumina who affirms this further adds that Naclerio’s participation in a self-regulating fund will easily influence capital and know-how from other investors who are thinking along the same interests. In any case, this is the only effective way to utilize Illumina’s capital that will create incremental shareholder value.

It is over yet about the fund. Its creation brings along an additional component to the genomics ecosystem. There are other things that Illumina has also been able to achieve like setting up an incubator. And its sleeves it has also acquired investments with top notch companies the likes of J. Craig Venter’s Human Longevity.

All eyes are now on Illumina Ventures to see how much more it shall profit from the genomics companies that are backing it.

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The study’s mission was to compare the levels of safety and efficacy between Zepatier and a treatment of Gilead Sciences, Inc. (NASDAQ:GILD)’s GILD Sovaldi (sofosbuvir: 400mg tablets). peginterferon and ribavirin (pegIFN/RBV) were also included and eventually Zepatier emerged superior to the regimen of Sovaldi plus pegIFN/RBV.

ZEPATIER Merck’s once-daily, fixed-dose combination tablet gained approval from the U.S. Food and Drug Administration in January 2016. The approval was received with enthusiasm whereby Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories outline the company’s commitment to help in the reduction of the global affliction and potential spread of chronic hepatitis C.

And even as the drug awaits its review from the EU, patients with inherited blood disorders and whose treatment may be challenging have something to look up as a result of the meaningful treatment options that Merck is endeavoring to develop.

Zepatier is already in delight of two Breakthrough Therapy designations in the U.S. It has its hands on chronic HCV GT1 for patients with end-stage renal disease on hemodialysis as well as chronic HCV GT4 patients.

And as if this is not enough for Merck, it has obtained an approval for its anti-PD-1 therapy supplemental Biologics License Application. Keytruda treats metastatic head and neck squamous cell carcinoma. The drug which is administered at a dose of 2 mg/kg and as an intravenous infusion over 30 minutes every three weeks is also endorsed for the treatment of metastatic non-small cell lung cancer and particularly in patients whose tumors express PD-L1.

The FDA has granted Priority Review to the drug whose application will be appraised under the agency’s Accelerated Approval program. Well, things are looking all good for the drug whose sales propelled from $55 million in 2014 to $566 million in 2015.

The post Results from Phase 3 Studies of ZEPATIER from Merck & Co., Inc. (NYSE:MRK) are comparatively positive appeared first on Sonoran Weekly Review.

In the year 2012, the state-run NHS spent a pretty low cost of around £2.3 million when Pfizer sold its epilepsy drug Epanutin (phenytoin sodium) in the U.K. However, the family doctors once spent more than £300 million annually on Pfizer’s Lipitor alone. Pfizer was to later sell the drug to U.K.-based Flynn Pharma, Stevenage. Other drugmakers also sold their generic versions but at higher prices which caught the pricing watchdogs off guard.

Well, a little more research revealed that Pfizer had actually overpriced the drug sold to Flynn at a rate 8 and 17 times higher than its historic prices. And as if his was not enough, Flynn pushed it up 25 and 27 times higher than what was formerly charged.

According to CMA the excessive was an abuse of a dominant position by the both companies and Pfizer has since been asked to orally explain itself which it has declined. And after being given 15 days to disclose the information and prove it was not doing anything wrong, Pfizer took nearly 20 days.

After too much hustling to get the proper information, CMA concluded that the company had failed to conform with a certain obligation under the country’s Competition Act with no good reason hence the £10,000 fine.

Reacting to the news of the fine imposed, Pfizer felt that CMA was unfair and excessive. The company further clarified that it had always taken its information production obligations extremely seriously and to some point gone beyond strict compliance.

But the Pfizer’s £10,000 fine is nothing to GlaxoSmithKline plc (ADR) (NYSE:GSK) which was with a $3 billion marketing abuse fine though not by the CMA. Nevertheless, the £10,000 may not have much effect on Pfizer since it has significant financial resources.

Nevertheless, the issue is already conspicuous in the industry and CMA is not amused with Pfizer. Well, it is still perusing through the documents provided before it can make its decision.

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The backers who are from a group of A-list have gathered a $31 million cash cache. The new operation dubbed Imara and which will be under the leadership of its co-founder, James McArthur has been well embraced by the two principals who have cited that it’s an amazing way of ramping up new companies by the accelerator.

Imara will take up the same build-out model as its premier, Vtesse. Well, the accelerator has been on the lookout for potential leads of rare disease drugs that are outside of oncology but could be useful in the launch of a new company. And Imara’s drug IMR-687 which is a phosphodiesterase 9 inhibitor fits in well. In any case, it is designed to have an influence on the pathology of the disease.

To ascertain if the drug can advance a therapy that can prevent irreversible damage Imara will test the drug in adults as well as juveniles.

McArthur is now in the process of recruiting a virtual crew of about 4 who will be responsible for managing the clinical development work. Their main role will be the carrying out of an analysis of a small molecule program for sickle cell disease from Lundbeck.

There is a potential in the arena of rare diseases according to the Cydan team that has taken two years to settle in. Nevertheless, Cydan CEO Chris Adams says that the team has been able to select 30 to 50 (rare) diseases which are well understood within the competitive space.

The company has more capability of driving through all the processes to a venture-backed portfolio while being able to explore a future for it. Venture backers have since facilitated the opening of doors to new deals.

The new development has since put Vtesse on trial to unveil pivotal data for its Niemann-Pick Type C1 disease which comes just a little more than two years after it launched.

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Well, in the recent past, there has been a tight competition in sales of various drugs. And having been considered to have an easier dosing regimen, Omarigliptin is also having a potential of being able to support the shore up of the grinding down of sales of its blockbuster Januvia/Janumet franchise which has been on the decline due to competition.

It is probably as a result of the muscled competition that Bernstein’s Tim Anderson allocated $429 million to omarigliptin in probable revenue for 2020. Nevertheless, things will not be the same again as Merck pulls off from filing the drug for the European markets. The company will not submit marketing applications for omarigliptin (MK-3102) even though it has an approval for being sold in Japan.

The company will not talk of any objections that may have been raised to the drug. There was a quick defense that the company’s decision to walk away was not as a result of any apprehensions about the effectiveness or safety of omarigliptin.

But apparently, a new report from healthcare analytics firm Advera Health Analytics stated that omarigliptin’s weekly therapy had more severe side effects than Januvia in two studies. It turned out that, the drug which was sold as Marizev had higher rates of prostate cancer, liver problems, hepatobiliary and pancreas or digestive system issues. All these and other issues could make it harder to market it.

But despite all these ups an owns, Merck R&D chief Roger Perlmutter is still holding up to its focus of experimenting with other diabetes drugs the likes of ertugliflozin which is under development in collaboration with Pfizer. The company’s earlier pipeline which includes GLP-1/glucagon co-agonists and novel insulins is also receiving emphasis.

The sad thing is that never has it been heard before of a Big Pharma company walking away from failure an particularly this particular one which was in its Phase II

The post Merck & Co., Inc. (NYSE:MRK) halts its Phase III rive of its once-weekly DPP-4 drug omarigliptin appeared first on Sonoran Weekly Review.

According to The Boston Globe, A grand jury in Charleston, West Virginia, has already sent out multiple subponers seeking documents concerning Boston Scientific’s purchase of a type of synthesis resin, used in making mesh implant.

The U.S. department is seeking to establish if Boston Scientific knowingly disguised substandard resin from China enabling them to necessary approvals from regulators and later on sold them to healthcare provider.

The allegation first cropped up earlier in January this year. A Houston based firm accused the Boston Scientific of allegedly smuggling material from china and using it to manufacture mesh devices. Mostyn law in a suit filed against the company Boston Scientific, notes that the company ran as an ‘international conspiracy’ to get counterfeit products. The suit notes that the company bough unverified substandard material from a known counterfeiter in China, who at time acts as a drug dealer to disguise multiple overseas shipment.

Mostyn law is now seeking unspecific damages to women who got a mesh implant from Boston Scientific after September 2012. The firm claims that a tally comes to approximately as many as 55,000 women in a year. Mostyn law claims that Boston Scientific lost its U.S. resin supplier and this is what influences the company to smuggle Chinese counterfeit products.

Transvaginal mesh are commonly used to repair a condition known as pelvic organ prolapse, that occurs when the bladder drops from the lower abdomen and press against the vaginal walls.  In some instances, the mesh linked to more serious health problems. Some of the health problems created by device include bleeding, infection, urinary issues, severe pain, and painful intercourse.

Boston Scientific is defending its product’s safety by noting that the company does not engage in use of counterfeit in their medical device. Spokesperson Kelly Leadem, noted that the company stands behind their products, the material used and their commitment to women’s health.

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The FDA advisory committee voted 12 to 1 in support of the thought that Clovis should first finish the Phase 3 study of rociletinib before the FDA can consider approving the drug for commercialization. Clovis Oncology Inc (NASDAQ:CLVS) had submitted what it considered concrete on rociletinib to the FDA and hoped that the agency would agree to an early clearance of the drug for marketing.

FDA typically follows panel recommendation

However, those hopes are almost perishing. While the FDA is not bound to follow the recommendation of its advisory panel, it often does. In that case, there is little hope that the agency will consider rociletinib for accelerated marketing approval before it receives the Phase 3 study data.

Concerns of side effects

Even before the FDA advisory committee issued its recommendation on the way forward with Clovis’ rociletinib, it had seemed that early approval of the candidate would be tricky. For example, rociletinib hasn’t had a decent efficacy profile from the previous studies. Additionally, dangerous side effects have been associated with the drug.

In reaching the decision to recommend against early approval of Clovis’ rociletinib, the panelists expressed concern that it was too early to clearly define the benefits and risks of the drug.

The fact that there are potentially better drugs for lung cancer appears to also work against rociletinib whose profile is not that bright.

The road to approval is long

The Phase 3 study of Clovis Oncology Inc (NASDAQ:CLVS)’s rociletinib is expected to conclude in late 2018. That means that the earliest the company can seek FDA clearance for the drug is 2019. In the meantime, the market is getting complicated. Clovis’ rociletinib competes against AstraZeneca plc (ADR) (NYSE:AZN)’s Tagrisso, which secured FDA marketing approval in November.

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SafeWire has four products in the minimally invasive surgery market, but two are of particular importance to Stryker Corporation (NYSE:SYK)’s Spine business. The two products are Y-Wire guidewire and Tiger Jamshidi needles.

SafeWire’s Y-Wire is used to enable fewer steps minimally invasive spine surgery. They are also used to lower exposure to fluoroscopy. Additionally they help to mitigate potential complications such as accidental pullout and wire migration.

In October 2014, SafeWire got CE approval for its Y-Wire products.

Tiger needle

SafeWire’s Tiger needles are designed to with its Y-Wire for bi-cortical fixation and tri-cortical fixation. They role is to help with mitigating issues associated with back-out and impact advancement during minimally invasive surgery procedures. SafeWire launched its Tiger needles family in the U.S. in 2014.

Broadening portfolio

The acquisition of SafeWire is expected to broaden and diversify Stryker Corporation (NYSE:SYK)’s Spine business portfolio. For example, the Stryker sees the acquisition helping it to expand its base of teaching facility customers.

A boost to laggard unit

Spine business is one of Stryker’s smaller and lackluster units. But the company has recently increased its focus on the Spine division and the efforts are starting to pay off. The division posted its third straight quarter of growth in 4Q2016.

According to Stryker Corporation (NYSE:SYK)’s CEO, Kevin Lobo, they are working on launching more new products with a 3D-printed interbody equipped planned for launch this year. Lobo said the launch of the 3D device will enable them to continue the growth trend in Spine division.

Marathon acquisitions

Stryker Corporation (NYSE:SYK) has announced a number of acquisitions in the recent months, including the $2.78 billion all-cash buyout of Sage Products, a unit of Madison Dearborn Partners.

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What was the study about?

According to Medtronic PLC (NYSE:MDT), some 331 patients with Type 2 diabetes were enrolled in a study that compared the performance of its MiniMed pump against MDI. The study progressed for 12 months, but some switching was done in the middle of study where patients in MDI arm were moved to the MiniMed side.

In the 12th month, Medtronic PLC (NYSE:MDT) says data showed that the patients who crossed over from MDI to MiniMed had remarkable improvement in their measure for glucose control. They MDI unit that crossed over were shown to have doubled their A1C measurement for glucose control. Additional, the patients used at least 19% less insulin.

As for the patient group that stayed on Medtronic’s MiniMed throughout the study period (12 months), their AC1 measure showed a further 0.1% reduction, coming to a a full-year mark of 7.8%.

What does the finding mean?

According to Medtronic PLC (NYSE:MDT), the latest findings about the superior performance of its MiniMed pump over MDI backs an earlier large-scale study that also turned up favorable results. The latest trials results are expected to help Medtronic expand access to its insulin pump treatment. The company believes that its MiniMed pump therapy can become the standard of care in dealing with the problem of Type 2 diabetes.

Medtronic’s Francine Kaufman said that the diabetes arm of the company is looking at how it can deliver more treatment options and better health for people afflicted by diabetes.

Medtronic PLC (NYSE:MDT) backed the latest study on MiniMed insulin pump that compared their efficacy with MDI.

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The recall of Fetch 2 catheter which is commonly used in processes to remove small blood clots from coronary arteries kicked off on March 22 an affected all those devices manufactured between June 11, 2014, and Feb. 19, 2016 and whose total was 21,155. The device which is under the Bayer brand was acquired alongside Bayer Interventional at a cost of $415 million, a deal that closed way back in 2014.

In a comment about the reason behind the recall, Boston Scientific stated that alt of shaft breakage happened during the procedure. Well, the broken section was removed and in some cases it was removed while still partially attached to the catheter shaft. Nevertheless, there were no cases of patient complications as everything ended smoothly.

There are several patients that have undertaken a thrombectomy using the device. Well, reliable sources indicate that they are safe since so far there hasn’t been any report of damage or death. But there is a word of caution that comes with it and is largely a potential severe outcome. Yes, the breaking of the device that fragments which could lead to the obstruction of an artery. It goes beyond this to the obstructing of blood flow which calls for additional surgical intervention for removal.

There is a clear proof that science is at the helm of growth. The realization has made Boston Scientific to send a word of risk avoidance to all healthcare facilities who have been asked to detest from using Fetch 2 catheters but instead to return them. What remains is now to watch and await further direction from Boston Scientific.

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Apparently, IBM has been filled with a slew of various partnerships and acquisitions in a span of one year. Well it is within the company’s efforts a commitment to tap into the application of AI to healthcare which will become a substantial source of revenues.

The use of power of Watson’s AI will come in handy during the ACS collaboration whose mission is to create a virtual cancer health adviser for patients A majority of patients are currently faced with the dilemma of obtaining information and more so for recent diagnosis.

The application of Watson’s artificial intelligence is expected to address local health challenges the likes of health worker shortages, accessibility of nutritious food and safe water as well as primary care insufficiencies.

Nevertheless, Watson is expected to give these patients a new lease of life following the training of the virtual center by ACS and the other people that are familiar with its use. It will no longer be reactive approach but a proactive approach as explained by IBM VP and CHO Kyu Rhee.

IBM is already having a series of cancer-related partnerships. It’s Chairman, President and CEO Ginni Rometty will be attending the World Health Care Congress in Washington, DC from where he shall detail IBM Health Corps.

The project has led to the completion of two pilot efforts and a third one is just about to start. One of t. he two pilots took place in Calderdale, U.K while the other was Johannesburg, South Africa. The third is likely to be in Washington, DC and its main purpose is to unite primary care and mental health care which in provides better management to chronic disease

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In as much as his 2015 compensation record which was at $24.2 million did not match the $25.0 million for 2014, Merck & Co., Inc. (NYSE:MRK) CEO Ken Frazier was still able to get a position among the pharma’s highest paid CEOs. And on the other side, his incentive pay was still higher and at $3.4 million compared with $3.3 million. And as if that he was not enough, Frazier collected $4.8 million in options an amount higher that the 2014 $3.3 million.

In its proxy statement Merck says that it has exceeded expectations in its financial performance. According to the compensation committee’s calculations, the company used the cost cutting strategy which led to the enhancing of earnings per share with 13 cents above Merck’s target of $3.40. It is perhaps this criterion that generated Frazier’s equity awards.

R&D also came in handy in racking up Frazier’s incentive pay. The company obtained ahead-of-schedule approval for the cancer immunotherapy Keytruda alongside a schedule-beating filing for its hep C cocktail Zepatier. Other approvals that gave him additional points included EU and Japanese nods.

And an additional achievement for Merck is being able to beat its 2013 goal of saving $2.5 billion in annual costs. The saving came from the cutting own of its employees from 70,000 to 61,000 as of December 31 2014.

Frazier’s base salary of $1.5 million stayed firm. Apparently this has been a shared figure across Big Pharma which gives indications of a growing industry. His pension earnings went up to $4.3 million from $3.6 million. Home security, retirement savings matching as well as tax prep compensations propelled to $283,000 from the $197,000 of 2014.

Nevertheless, Frazier’s compensation matched that of Johnson & Johnson (NYSE:JNJ) CEO Alex Gorsky who took home a $23.8 million package. Brent Saunders CEO of Allergan followed closely with a $21.6 million. And from the look of things, the Pharma is embracing itself for a steep competition as they seek approvals for various drugs.

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Castagna, a pharmacy degree holder and who exited from Amgen, Inc. (NASDAQ:AMGN) is well-settled into his new job having already hired an advertising agency that is expected to map the new marketing direction for Afrezza. The new leader’s first assignment is to drive into endocrinologists’ strategy. And as Sanofi lay its target on care physicians who treat Type 2 diabetics, MannKind will walk directly to the 5,000 endocrinologists in the U.S who treat both Type 1 and Type 2 diabetes patients.

The guru who has been in the industry for 20 years says that many endocrinologists o not have details on Afrezza. Hence it is important to get them up to speed on its usage even before the launch of DTC campaign whose plans have just began.

According to him, it is not just telling the insulin patients to try it out but it has everything to do with emotional connection. Remember this disease has become part of these people’s lives.

MannKind is now targeting the larger markets that already have tonnes of doctors and patients that are more familiar with the product. And with the experience in lots of specialty brands Castagna is pleased with the efforts by MannKind in its process to remove managed care barriers. Nevertheless, he admits that he has not encountered a brand that has patient advocates like the current one an apparently these advocates o not have any direct ties with the company.

All eyes are now on Castagna to see how far he can drive MannKind’s mission and vision having shepherded several drug launches at Bristol-Myers Squibb Co (NYSE:BMY) and Sandoz Inc.

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Monthly data reviews from iSpot.tv indicate that in five out of seven months, Humira has been the No. 1 TV advertiser having spent $357 million on TV, print, radio as well as paid search, display and other ad formats for the year. Kantar’s Media tracking also reveal that Humira recently took the top spot for total 2015 advertising.

It had three approved indications during the month of March all which spent $15.3 million on seven different TV spots, a clear indication that it is not letting go its push.

GlaxoSmithKline plc (ADR) (NYSE:GSK) fell into the second slot with a $12.1 million expenditure its ads for its respiratory drug Breo. The expenditure was higher than the $9.4 million spent in February which demonstrates that competition is predominant.

Eliquis, the anticoagulant from Pfizer Inc. (NYSE:PFE) and Bristol-Myers Squibb Co (NYSE:BMY) took up the the third position with an estimate spending of $11.7 million on TV ads in March which was down from $13.9 million in Feb. Nonetheless, it had the biggest expense on its DVT and PE Blood Clots Ad whose estimation was at $6.5 million.

Seemingly, there was heavy TV advertising expenditure by the top pharma marketers. However, the spending was not intense in March compared to the New Year’s kickoff in the months of January and February. The collective expenditure for the top 10 was at $108 million down from $126 million and $162 million in February and January respectively.

Well, the drop in expenditure in the month of March could be explained by the lack of expensive TV placements the likes of NFL playoffs and the Super Bowl which were present in January and February.

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According to IBM researcher Stefan Harrer, they are seeking the capability of being able to extract all the meaningful information from all the background noise of the system. Their interest is in being able to detect seizures for specific patients using the network which is more or less similar to that of Facebook that is used to recognize commands in Androids.

Harrer and team intends to use an experimental IBM chip called TrueNorth to run the neural network and unlike many others, it is flexible, does not use so much power and besides there are high chances of running it on a laptop, tablet or phone.

The research of the new system is as a result of a previous study at the University of Melbourne from which scientists gathered data from a a not as much of complicated implant that took EEG readings from epilepsy patients over three years. The team has now tagged their training on neural network on this particular data from which they are optimistic of gaining vital information on the way forward with their new system development.

A senior research fellow at the University, Dean Robert Freestone says that the main focus is to help in the replacement of the broken neural systems with machines that can easily interact with the brain in a very natural way. It is within this reasoning that the team will not relent. And in any case, the chip is likely to bring out a device that will work hand in hand with a brain implant which will give a 24/7 to monitoring of seizures.

The team is optimistic of its prospects which may also facilitate the detection of seizures at onset and in return send out electrical impulses to stop them.

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The most surprising thing is that Read has gained so much support from a poll of 10 of the company’s investors who have given him  credit for that which he has accomplished with Pfizer. However, this is the second time that he is unable to pull off a major merger.

According to the investors, Read has nothing to do with Allergan’s failed deal.  Instead they have tagged the fault to the U.S. government. Among the investors that have applauded Read is portfolio manager at Columbus Circle Investors, Oliver Marti who says that Read’s decisions are smart. An after all he took up the company in 2010 when it was at its weakest.

Nevertheless, two years ago and for nearly $120 billion deal, Read and Pfizer were declined by AstraZeneca plc (ADR) (NYSE:AZN) shareholders. The deal which was under a heavy influence of British politicians would have facilitated Read’s tax rate cut that he craved.

Marti claims that despite the hard work which was within rules, the treasury still maltreated its authority and made up its own rules hence the collapsing of the Allergan deal which was equally smart. And under very unclear circumstances, Allergan announced the striking of a $3.3 billion licensing deal for global rights to a wide range of drugs for neurological disorders from the U.K.’s Heptares.

Well, both companies have back up plans according to Allergan CEO Brent Saunders who says that despite the disappointment Read may have to embrace, his focus is still on Pfizer and its independent future.

Pfizer will not lay more emphasizes on whether or not it should break into two separate businesses a decision that had been postpone to 2018 after striking the Allergan deal. The company will also hit the road to seek for new deals that will help in topping up to its value.

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Ironwood and its partner Allergan plc Ordinary Shares (NYSE:AGN) now stand separated from OTC offerings, a position that helped them develop U.S. deals to $454.8 million a year ago. The way he saw it, on the off chance that it was the previous, well, they fundamentally got a diuretic, McCourt said. In any case, it was the latter and that put the med on a direction he supposes will in the end take the item to the blockbuster limit and past.

What Is Happening

The companies have taken that separating element and keep running with it. Allergan, with its wide business reach, has become through to a huge number of essential care doctors, alongside the payer group. More than 170,000 docs have endorsed the medication, and 75% of protected patients have unlimited access to it, as per McCourt. The organizations have as of now propelled three DTC endeavors, with the most recent putting patients up front to highlight their individual stories and tout the medication’s focal points over OTC cures.

The consequence of the advertising endeavors of the companies has led to $454.8 million in U.S. deals in 2015, up from $173.2 million only in 2014.

Good Start

The advantages of an effective Linzess push aren’t ceasing there. As Allergan’s Branded Pharma head told speculators that essential care capability it developed with Linzess helped it surpass early dispatch desires with new IBS-D item Viberzi. This was an execution that will be particularly imperative for the drug maker in the wake of its wiped out $160 billion Pfizer Inc. (NYSE:PFE) merger. The end of the deal has been a major heartbreaker for the companies.

He said that they went into that market with Viberzi right along alongside Linzess, and when they look at the prescription volume or sales levels in that segment or market, the results seem very encouraged.

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The U.S. government hurled barriers to keep Pfizer from moving to Ireland, where Allergan was currently based. While disappointment on that scale regularly places CEOs in peril, as many as 10 speculators and portfolio supervisors supported Read. This has put Pfizer on the right spot in the market.

According to them, the CEO had a profound repository of goodwill subsequent to handling numerous issues he acquired since assuming control in 2010, including re-empowering Pfizer’s floundering innovative work operations. Also, a large portion of them accuse the U.S. government, not Read, for the Allergan arrangement’s fate.

Pfizer Has Bright Future

With about $50 billion, Pfizer has different alternatives, including turning off its huge marked generics business. Pfizer had pushed back that choice by two years in declaring the Allergan bargain, yet said it will now decide before this year’s turnover. Pfizer shares climbed 5 percent after the arrangement was scrapped. Read is likewise liable to make different acquisitions to shore up its patent-secured tranquilizes unit before shedding its generics business.

Support For Read

Oliver Marti from Columbus Circle Investors, which has been a Pfizer speculator, said Read has settled on some extremely keen choices and the arrangement to purchase Botox creator Allergan was one of them.

Read is not the one who needs to be blamed, concurred Tony Scherrer, chief of research at Smead Capital Management, a long-lasting Pfizer shareholder.

The Treasury and numerous U.S. lawmakers, including presidential competitors, have contended that U.S. organizations ought not be permitted to strike arrangements to abstain from paying charges.

Allergan CEO Brent Saunders said that the organizations had emergency courses of action set up if Treasury changed the guidelines once more. While certainly Ian was left baffled, he hasn’t avoided a beat and is totally centered on Pfizer and its autonomous future, Saunders concluded.

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The miniature device can be installed directly into the right ventricle chamber of the heart. Conventional pacemakers are connected to the heart through wired leads. The announcement of the FDA’s approval for Medtronic’s pacemaker comes a few weeks after the regulator’s consideration for leadless pacemakers. Implanting the micro pacemaker does not require surgery. Instead, it is introduced into the heart through a catheter, and this minimizes the invasiveness of the process.

The device responds to the heart rate of the patients and adjusts by stimulating the heart in the right way. One of the major problems with regular pacemakers is that leads can pose a problem to patients when they malfunction, and they can also induce infections to the surrounding tissue. In such cases, they require surgery for replacement. Regular single-chamber pacemakers are implanted near the subject’s collarbone, and they travel to the right ventricle of the heart through a vein so that they can perform their intended purpose which is to deliver pulses.

Dr. William Maisel from the FDA stated that the device (the Micra Transcatheter Pacing System) is a welcome addition to patients who are thinking about using single-chamber pacemakers because Micra avoids problems tied to wired leads. Dr. Maisel is the current director of the FDA’s Office of Device Evaluation at the organization’s Center for Devices and Radiological health. Dr. Dwight Reynolds, the chief of THE University of Oklahoma’s cardiovascular section stated that Mica is the transcatheter pacing solution that the medical industry has been waiting for. He added that the approval from the FDA means that it will soon be available in the market.

Medtronic carried out trials which involved 719 patients and 98% of the test subjects experienced satisfactory heart pacing six months after receiving the device. Only 7% of the patients experienced complications such as pulmonary embolism, deep vein thrombosis, and prolonged hospitalization.

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Amgen argues that rather than using substandard methods to combine multiple and contrasting trials, thorough and balanced assessments should be put into practice, an act that will lead to increased dependence on direct data from rigorous absolute trials. Otherwise, all the rest would cause discrepancies and different estimates of efficacy and probably lead to assumptions that will create unrealistic results.

The company further states that results should only be produced by independent organizations which will exercise transparency and which will undertake complete and independent peer review.

But despite the setback, the Big Biotech is of the opinion that if used alongside Revlimid and dexamethasone from Celgene Corporation (NASDAQ:CELG), Kyprolis would present an economic value to patients whose disease had not progressed.

It turns out that Amgen is the first to challenge the body’s report which in fact is yet to be published. However, Kyprolis is not the first medication to receive ICER’s wrath.

The new respiratory drug from GlaxoSmithKline plc (ADR) (NYSE:GSK), Nucala is also on the spot. ICER says that it should trade for as much as 76% less than it current price. And as if ICER is not done yet it has bashed PCSK9 contenders from both Amgen and the Sanofi/Regeneron team citing that their prices are three times higher hence they could not stay in line with healthcare budgets.

Other newcomers that are in the spotlight include Johnson & Johnson‘s (NYSE:JNJ) Darzalex, Empliciti and Takeda’s Ninlaro from Bristol-Myers Squibb Co (NYSE:BMY). But all the same, Amgen is not moved by the latest competition. The company says that the medication has made a name for itself in the market having grown more than expected.

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The news comes at a time when AstraZeneca and Takeda are struggling to turn around flagging fortunes. And apparently the duo had so much hope that the diabetes drugs would give new looks to the sales. There were also expectations that the drugs could improve the prosperities of competitor drugs like Januvia from Merck & Co., Inc. (NYSE:MRK) which is also within the DPP-4 cluster but does not have the warning.

The FDA particularly mentioned AstraZeneca’s Onglyza and combo drug Kombiglyze XR alongside Takeda’s Nesina and combos Kazano and Oseni

The warning to the labels of DPP-4 inhibitors which was overwhelmingly recommended by an FDA advisory panel is the second in less than a year. It came during a review of Onglyza. The results from two large clinical trials of the drugs in patients with heart disease revealed that 3.5% of patients taking saxagliptin suffered from heart failure which led to hospitalization. The rate for patients taking placebo was at 2.8% and 3.9% vs. 3.3% for alogliptin.

The latest unfolding is thorn in the flesh for Onglyza’s sales in the U.S. They have literally affected the yearly revenues which were flat at $786 million last year but were down 13% in the U.S. to $420 million. Earlier on CEO Pascal Soriot had expressed his commitment to deliver annual revenue above $45 billion by 2023 with an $8 billion expected to come from its diabetes assortment.

The commitment, however, got a kick on its back after the FDA declined to approve AstraZeneca new SGLT2/DPP-4 combo, a mix of Onglyza and Farxiga and instead asked for additional data. Things seem to be getting tough for AstraZeneca which has hoped to generate $3 billion in peak sales for the drug. It will now have to abandon all its plans and which will pave the way for its competitors.

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However, one case was left pending in court which states that Pfizer’s antidepressant results to congenital heart defects in babies after its consumption by their mothers. The claim also puts the company on the spot for having failed to send a warning to patients about potential risks.

But in its defense, Pfizer says that it had briefed the FDA and the public on the safety issues associated with Zoloft. Besides, there is no evidence ascertaining the birth defects stated on the claim. Pfizer argues that there is immense scientific support of Zoloft’s safety and accurate measures which are science-based. And in any case, the FDA gave an approval of its information on its benefits and risks.

Well, this is not the only win for Pfizer as far as Zoloft is concerned. Sometimes last year, the company was again let off the hook of two jury trials in St. Louis and Philadelphia and escaped the payment of $2.4 million in damages. In fact, lawyers showcased their evidence that Pfizer scientists were aware of the possible link between Zoloft and birth defects. However, Pfizer watered down all those claims citing that the drug’s official label cautions women against the conscious consumption of the drug during the duration of pregnancy.

In October, a couple moved filed a suit against Pfizer claiming that the use Zoloft had caused birth defects in their son but a Philadelphia state court judge dismissed the suit.

Nevertheless, the regulators have since taken up the concerns of the various safety problems with Zoloft.

Meanwhile, GlaxoSmithKline plc (ADR) (NYSE:GSK) is also in the league of pushbacks over safety disputes related to its antidepressants Paxil. In fact, it has already spent more than $1 billion to settle down hundreds of litigations originating from claims that its antidepressant heightened the risk of birth defects.

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 Samsung spokesman Mingi Hyun said that the large number of overlapping patents around Humira were likely to hinder patients access to affordable medication.

And in the wake of the need for affordable healthcare, recent reportfrom the IMS Institute for Healthcare Informatics shows that U.S. and Europe could be beneficiaries of close to $110 billion by 2020. The use of biosimilars could save the health systems.

It is this trend that companies like Samsung and Biogen are intending to cash in and from where Samsung aims for 1 trillion won ($872 million) in sales. However, this may not be an easy task for Samsung because if it has to hit its target, it needs to get around AbbVie’s patent protections for Humira.

But from the look of things, AbbVie isn’t bowing out. In fact it is broadening its defense strategy to defend its intellectual property and it is optimistic that it will be able to keep biosimilars at bay from Humira in the U.S. It will take advantage of new formulations, label expansions and pricing wins and make maximum value from them. In any case the current company’s formulation patents on Humira are expiring later in the year in the U.S.

Nevertheless, analysts have a different take on Humira’s prospects. Andrew Baum’s predictions for last year state that Sales of the drug are likely to sway to a big shit from 2018 where revenues will drop from $16 billion in 2017 and o $6 billion in 2022. But even with all these predictions, the company has opt to remain optimistic and at its peak of response, it is targeting significant international growth of such products like Viekira Pak.

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Apparently, it is only a month ago when Gilead obtained the FDA’s approval of its combo treatments for HIV, Odefsey–a single-tablet combination of emtricitabine which was approved as Emtriva.

The new drug has a comparable antiviral activity as Gilead’s older HIV drug, the TDF treatment Viread. However, it can also be administered at lower doses than Viread since the entry of TAF into the HIV-infected cells is more efficient than that of TDF. Well, there is optimism from various analysts that the latest drugs from the company will reach the expected blockbuster sales.

And if the latest is not enough for Gilead, another approval from the FDA came through in November for Genvoya, a combined tablet designed to keep HIV from replicating itself. It has Emtriva; cobicistat having been cleared as Tybost; elvitegravir and on the market as Vitekta.

The latest unfolding for Gilead are an important evolution in HIV care according to the Company’s executive VP of research and development, Norbert Bischofberger. On the other hand, the components of Descovy present patients with an effective combination of a drug that is safe and has the potentiality of improving health.

But all said and done, Gilead is still not off the hook of competition. Johnson & Johnson (NYSE:JNJ) and the joint venture ViiV Healthcare will not relent in fighting back for its market share. And with all of them working on combination therapies to compress down HIV then all must up their game in garnering shares within the multibillion-dollar market.

Well, Gilead has had a difficult moment with its oncology pipeline but even so, it is not wholly relying on its antiviral portfolio.

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Well, the drug shall be co-marketed by Pfizer Inc. (NYSE:PFE).  It shall lead to identification of indications related to rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, rheumatoid arthritis and Crohn’s disease.

And despite the regulator’s approval, J&J had protested against the clinical data with claims that it was not addressing the residual uncertainty regarding its use in inflammatory bowel diseases. Nevertheless, the pharma giant seems to have embraced the fight.

Meanwhile, J&J’s Chief Biotechnology Officer Jay Siegel has stated that the FDA’s approval of Celltrion’s infliximab-dyyb does not make it an interchangeable for Remicade. Siegel says that the biosimilar must produce similar clinical results as the reference product in any given patient so as to be determined as an interchangeable.

And according to Damien Conover, a Morningstar analyst, Remsima and another Remicade knockoff could make it big into the J&J’s U.S. revenue by 2020.

In the recent past, FDA has been bringing on board new rules in favor of generics with labels similar to the originals the earliest beneficiary being Celltrion and Pfizer. Already the agency has laid out its guidance on labeling of biosimilars having struck a strong position for the ‘generic-like’ label.

But Pfizer has remained quiet about its marketing strategy and whether or not it will have a competitive price point. Questioned about it future plans, the pharma giant refused to divulge any information about its future development and commercialization strategies.

One of the earlier FDA’s approval beneficiaries is Novartis AG (ADR)(NYSE:NVS) with its Zarzio, a biosimilar of Amgen, Inc. (NASDAQ:AMGN) Neupogen. The approval came through late last year and was the e wave first in the waves of knockoffs.

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The reasons for the high optimism about the sales potential of dupilumab are the large addressable market and the fact that Sanofi SA (ADR) (NYSE:SNY) are working to expand the drug’s label beyond eczema.

Positive trial data

Although predictions about revenue potential of dupilumab have been widely floated in the recent times, it is the latest report of Phase 3 trials of the drug candidate that clearly provides a hint about its sales potential. Sanofi SA (ADR) (NYSE:SNY) and Regeneron recently reported data from two separate Phase 3 trials of dupilumab in patients suffering from moderate-to-severe atopic dermatitis (AD).  The data from the Phase 3 studies showed that dupilumab was able to significantly clear skin, reduce itching and improve the mental health and quality of life of AD victims compared placebo.

Regulatory filing

Sanofi SA (ADR) (NYSE:SNY) and Regeneron will include results from those late-stage trials in their regulatory filing for marketing approval of dupilumab. Those companies are expected to seek FDA approval of dupilumab in 3Q2016.

Existing solutions are ineffective

Regulatory approval of dupilumab will not only unlock huge revenue opportunity for Sanofi and Regeneron, but also provide reprieve for those afflicted by eczema. Existing treatment for the conditions are not only less effective, but also come with serious side effects. For example, the immunosuppressants currently in use for treatment of eczema expose users to the risk of cancer and other dangerous infections. Topical steroids are also used to tackle eczema but they are not any better because their side effects include things such as skin-thinning.

If approved, Sanofi’s and Regeneron’s dupilumab will be the first of immunotherapies for eczema to hit the market. Dupilumab presently has FDA breakthrough designation is it has the potential to address an unmet medical need.

Addressable market

Atopic dermatitis affects millions of people globally. In the U.S. between 7 and 8 million adults are said to be afflicted by AD, but only about 1.6 million have had their cases diagnosed and treated. Therefore, there is a huge addressable market for Sanofi and Regeneron to address with dupilumab if they secure commercialization approval for it.

It is the huge addressable market that makes analysts hopeful that the treatment could rake in more than $5 billion in annual revenue.

Sanofi SA (ADR) (NYSE:SNY) and Regeneron are also looking to expand the treatment mandate of dupilumab to include conditions such as asthma.

The post Why Analysts See $5 Billion Revenue Potential For Sanofi SA (ADR) (NYSE:SNY)’S And Regeneron (REGN)’S Dupilumab appeared first on Sonoran Weekly Review.

Nimbus Apollo is one of the several units of Nimbus Therapeutics and it is backed by a host of investors including Microsoft Corporation (NASDAQ:MSFT) founder Bill Gates and Atlas Venture. Nimbus is a holding company whose activities revolve around seeking partners for its drug programs, selling those programs and developing new programs.

Some of the big pharma backers of Nimbus are Eli Lilly and Co (NYSE:LLY) and GlaxoSmithKline plc (ADR) (NYSE:GSK).

Main target on NASH

In this case, Gilead Sciences, Inc. (NASDAQ:GILD) will be getting its hands on a promising potential treatment for non-alcoholic steatohepatitis (NASH). The main target of the drug candidate that Gilead is buying is NASH, but it has the potential of being leveraged for treatment of other liver conditions beyond NASH.  The drug candidate is known as NDI-010976 and it was recently in Phase 1. Results from that study are due for release in the coming weeks.

Boost to Gilead’s internal NASH efforts

It is not clear why Gilead Sciences, Inc. (NASDAQ:GILD) has moved to acquire Nimbus Apollo just a few weeks to the release of Phase 1 data for NDI-010976. Nevertheless, the acquisition is expected to boost Gilead’s portfolio of potential NASH drugs. The company has in its pipeline four NASH-themed programs at various stages.

According to Gilead’s research chief, Norbert Bischofberger, the acquisition of ACC-inhibitor NDI-010976 from Nimbus Apollo will accelerate their efforts to fill the gap in the unmet needs for NASH treatment. The company further believes that NDI-010976 will complement its existing in-house efforts in looking for better NASH treatments.

NASH afflicts millions of people in the U.S. and Gilead has been doubling down its efforts in the space.  Gilead is best-known for its costly Hepatitis treatments called Sovaldi and Harvoni.

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At the time of its launch last year, Entasis Therapeutics received $40 million in Series A funding from mainly its parent AstraZeneca plc (ADR) (NYSE:AZN).

Latest backers

Clarus Ventures led the latest Series B financing of Entasis. Other investors who participated in the latest round include Novo A/S, Eventide Funds and Frazier Healthcare Partners. Some of these investors such as Clarus have got representation on the board of Entasis. In a move that expands Entasis’ board of directors, James Topper of Frazier, Nicholas Galakatos of Clarus and Peter Tuxen Bisgaard of Novo have been added to the board.

AstraZeneca plc (ADR) (NYSE:AZN) sought to spinout Entasis after it failed in multiple efforts to secure buyers for the unit. Although Entasis had 175 employees when it was still a part of AstraZeneca, it launched as a separate entity from the parent with 21 employees.

What’s the money for?

The funding that Entasis has received from Series B financiers will help it progress its pipeline. The company has a number of preclinical drug candidates and a mid-stage program focused on the treatment for gonorrhea.

Entasis’ main area of focus is developing treatments for bacterial infections that have become resistant to existing antibiotic treatments. Global health agencies have sounded alarm over growing antibiotic-resistance with gonorrhea being among the top worries. The other treatment areas that Entasis is focusing on are blood infections, pneumonia, urinary tract infections and a host of other common infection areas threatened by antibiotics shortage.

The reason investors are pouring in on Entasis is that they are excited by the company’s pipeline and they believe it stands a better chance of success.

AstraZeneca de-risking move

As for AstraZeneca plc (ADR) (NYSE:AZN), spitting Entasis helped it reduce exposure to early-stage antibiotic drug development.

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The drug’s approval in Europe will be the first of its kind and it means that patients anywhere in the world will be able to access the therapy. According to Glaxo, the treatment’s purpose is to bring back the capability of being able to make healthy lymphocytes, the white blood cells that facilitate the body’s response to immune.

Word has it the therapy’s treatment is the most advanced among a group of other Glaxo products whose main role is to correct faulty genes that cause rare diseases and cancer.  And that said, the company has revealed that plans are underway to file for approval with the U.S. Food and Drug Administration (FDA) hopefully early next year.

Head of Glaxo’s rare-diseases unit, Martin Andrews says that 120 to 300 patients suffer from the rare condition globally. Well, estimates have it that from 10 patients who can’t find a matching donor for a bone-marrow transplant, eight of stand good chances of benefiting from Glaxo’s products.

The therapy’s administration is a one-time procedure. It serves as a more affordable enzyme replacement that costs millions of pounds as a result of the weekly injections.

And having taken all the efforts and the expense to invest in Strimvelis for the last six years, Andrews explains that the company is optimistic of being to spread the benefits over to other medicines in GSK’s portfolio. Estimations are already showing the likelihood of Strimvelis being able to hit 67.5 million pounds in sales in 2020.

So how shall Glaxo approach the pricing aspect to make this therapy more affordable than any other? According to Andrew, the company is likely to allow repaid payments over the duration the treatment is used. It could also embrace a risk-sharing program to the benefit of the patient.

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J&J found  Fulranumab, an anti-nerve growth factor (NGF) antibody for osteoarthritic pain back in 2008 from Amgen, Inc. (NASDAQ:AMGN) and to whom J&J has decided to hand it all back. The drug has undergone years of expensive trials before the hopes of being able to hit the market were   shattered by a safety disaster in 2012.

Nevertheless, Gorsky says that there is hope for J&J having reported positive gains in sales of other prescription drugs in the fourth quarter. In fact since the launch of 14 products in 2009, six of these products have passed the threshold of $1bn in sales.

Apparently, J&J’s osteoarthritis pain drug was leading the charts of performance five years back. It was one of the hottest R&D races in the industry having worked too well on patients but to a point of activating a clinical hold for the class at the FDA. It worked more or less like tanezumab from Pfizer Inc. (NYSE:PFE) and fasinumab from Regeneron Pharmaceuticals Inc (NASDAQ:REGN).

But despite all what happened to the anti-NGFs, the big biopharma groups still maintained their appetite for them. And true to the word, their craving led to a $1.8 billion partnership between Eli Lilly and Co (NYSE:LLY) and Pfizer back in 2013 with an upfront payment of $200 million in early 2015 after the lifting of their hold by the FDA.

Regeneron was not left behind either having entered into to a $325 million Asia contract with Mitsubishi Tanabe on their anti-NGF, fasinumab. Well, sources indicate that J&J is still not willing to diverge into details as to why they had to hand over the drug to Amgen.

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Copaxone’s intention was to obtain brand exclusivity againstits first generic competitor, Sandoz’s Glatopa. Well, the price break was a flop since the determination of preferred product was made by the payers hence buyers could not shift volume to its products and this was a major disappointment for Sandoz.

At the same time Sandoz could not make any attempt to compete with Teva because it may not have made an economic sense because most payers were protectedby the “rights to match” contracts with Teva. And instead of waiting any longer, Sandoz decided to apply its strategy to its mother company Novartis AG (ADR) (NYSE:NVS). The company went ahead to fend off copies of its own aged blockbuster, Gleevec.

And in the face of Glatopa competition, Teva was able to retain a between 70% and 75% of Copaxone 20mg’s share, something that caught the market by surprise. However, Gleevec generic from Sun Pharma was also able to grap a share of the pie of up to 30%.

Meanwhile, Bernstein analyst Ronny Gal has warned that it is not always that the obligatory brand will always win. Recently, various generics have become very proactive in seeking for deals with payers which will facilitate exclusive generic launches. So Gal advises that every company has a role to play to rise above the storms.

And if other branded drug makers have to win the pricing war, they must provide a percentage of the market to their copycat rivals. So whichever company wants to compete with the likes of Teva and Novartis’ experiences, the must manage their markets way beforehand.

The post Will Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) And Novartis AG (ADR) (NYSE:NVS) Rise Above Are Fending Off Copycats? appeared first on Sonoran Weekly Review.

The PTNM device expands Medtronic PLC (NYSE:MDT)’s offerings in neurostimulation market and could unlock significant new revenue for the company. The launch of the bladder control device could also help Medtronic to iron out issues that have recently plagued its Neuromodulation division.

What’s the market opportunity?

In the U.S. alone, over 37 million adults are afflicted by bladder control issues. Globally, the number of people with the problem is expected to rise to 546 million by the next two years.

High dropout rates

Bladder control problems adversely impact suffers’ professional and social lives.  Although many people suffer from bladder control problems, only 33% of them seek treatment. Unfortunately, the vast majority of OAB suffers drop out of their treatments within 6 months. The reasons for the high dropout rates are said to be poor results for existing medications and adverse side effects from existing treatments.

Medtronic PLC (NYSE:MDT) believes that its FDA-approved NURO system for OAB correction will enable victims of the conditions to overcome treatment challenges they may have experienced in the past. The company says that its device for correction of bladder controls anomalies is inserted in the body in a minimally invasive procedure that can be done at a physician’s office during the 30-minute regular visits.

Once the NURO system is placed in the body, it uses electric pulse of the body to reduce episodes of urinary urgency. The device is placed under the skin and near the ankle to generate electric pulses.

$6.2 billion market

The global neuromodulation devices market is expected to hit $6.2 billion by 2021. With the launch of bladder controls NURO system, Medtronic has just increased its chances to grab a larger share of that market.

Medtronic PLC (NYSE:MDT)’s device for OAB condition originated from Advanced Uro-Solutions, a privately-held firm it acquired in early 2015. Advanced Uro-Solutions’ domain is developing neurostimulation products geared towards bladder controls.

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Use for the funds

ImmuneXcite intends to use the money raised from the latest Series A financing to complete its various pre-clinical studies. After that, the company will select a lead program to take to clinical trial.

Sanofi SA (ADR) (NYSE:SNY) participated in ImmuneXcite’s latest fundraiser through its unit called Sanofi Genzyme BioVentures. The other investors that participated in the round include Partners Innovation Fund and Cormorant Asset Management.

Positive preclinical data

As ImmuneXcite looks to enter clinical trials, the company is set to start from a positive position. Last year, the company reported positive results from a preclinical trial of its mAbXcite platform. The therapy was found to be effective in harnessing the power of T-cells to combat treatment-resistant breast and colorectal cancer.

ImmuneXcite is looking to play a leading role in the rapidly expanding field of cancer immunotherapy. Here is where a complex biotech platform is used to recruit T-cells to fight cancerous cells.

Sanofi SA (ADR) (NYSE:SNY) and other drug companies looking for new growth opportunities have been showing great interest in immuno-oncology projects.

Executive appointments

Following the latest fundraiser backed by Sanofi SA (ADR) (NYSE:SNY) and others, ImmuneXcite has also announced the addition to certain veterans to its executive team. For example, the company has tapped Eric Furfine a veteran of Regeneron Pharmaceuticals Inc (NASDAQ:REGN), Eleven Biotherapeutics Inc (NASDAQ:EBIO) and GlaxoSmithKline plc (ADR) (NYSE:GSK) to be its caretaker CEO and CSO. Furfine will also sit on ImmuneXcite’s board of directors.

Jim Geraghty, a veteran of Sanofi SA (ADR) (NYSE:SNY), has also been appointed to the board of ImmuneXcite. Ann DeWitt, a principal at Sanofi’s Sanofi-Genzyme BioVentures, will also sit on the board of ImmuneXcite.

As ImmuneXcite looks to make money selling immuno-oncology treatments, it will face a growing number of competitors. Many biopharmaceuticals are looking to harnessing the power of the immune system to develop advanced treatments for some of the most debilitating diseases troubling man.

The post Sanofi SA (ADR) (NYSE:SNY) Backs ImmuneXcite In $8.6 Million Funding Round appeared first on Sonoran Weekly Review.

Novartis AG (ADR) (NYSE:NVS) is selling 14 non-core brands to Sun in a transaction that will immediately yield $293 million for the seller. The older drugs that Novartis is offloading to Sun in Japan brought revenue of about $160 million in 2015.

Novartis AG (ADR) (NYSE:NVS) will continue distributing the drugs on behalf of Sun until the buyer has sort out its local marketing and distribution systems.

Opportunity to expand quickly

According to Sun’s officials, the acquisition of the 14 prescription drugs from Novartis paves the way for the company to accelerate its expansion in Japan. The company also expects the deal to allow it to rapidly build up its portfolio of drugs as it looks forward to future growth abroad.

Trouble in Japan

Novartis AG (ADR) (NYSE:NVS) is selling its established brands in Japan at a time when the company has had multiple troubles in the country in the recent times. For example, Novartis’ Japanese arm was in 2014 indicted over claims of manipulating clinical trial data for a blockbuster drug for the heart. Again in 2015, the company was punished with a 15-day operations suspension over claims that it failed to proper disclose side effects of a drug.

Industry-wide trend

As for the sale of aging brands, Novartis AG (ADR) (NYSE:NVS) joins a growing list. The likes of Abbott Laboratories (NYSE:ABT), Merck & Co., Inc. (NYSE:MRK), GlaxoSmithKline plc (ADR) (NYSE:GSK) and AstraZeneca plc (ADR) (NYSE:AZN) have all offloaded non-core assets in one way or the other. AstraZeneca has particularly perfected the art of hiving off and monetizing older brands. Part of the reason for the aggressive sale of established brands by Big Pharmas is to release cash for investment in other key growth projects and also to simplify the structure of the company so as to drop some costs, have a more focused sales team and boost earnings.

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An anonymous whistleblower has claimed that Novartis AG (ADR) (NYSE:NVS) paid a consultancy firm called Alp Aydin Consultancy to persuade state-run hospitals in Turkey to add its medicines to their scripts.

Novartis has neither owned up nor denied the claims, but has said that investigations have been launched into the allegations. The latest bribery claims in Turkey put Novartis in a more awkward position as the company only recently reached a $25 million settlement with the U.S. Securities and Exchange Commissions (SEC) over corrupt practices in China.

Just last month, authorities in South Korea raided the company’s local offices and confiscated documents including account books in what looks like corruption related scandal. Korean media reported that the rebates that Novartis was offering doctors in the country had raised eyebrows.

Name change approval

In Turkey, the whistleblower alleges that Novartis AG (ADR) (NYSE:NVS) officials worked schemes to boost scripts and also sought to influence government to allow it to change the names of certain drugs. The logic behind the renaming of the drugs was to forestall potential agitation for price cuts in other countries.

Jobs to doctors’ relatives

Moreover, Novartis AG (ADR) (NYSE:NVS) is alleged to have offered employed to relatives of certain doctors at its Turkish unit. That was done as a rewarded to the doctors who wrote large number of prescriptions for Novartis drugs.

Alp Aydin Consultancy allegedly received $290,000 from the Novartis to facilitate the bribery of Turkish hospitals. At the end of the day, Novartis is said to have earned itself an $85 million market advantage.

Tainted image

Besides South Korea and China, Novartis AG (ADR) (NYSE:NVS)’s marketing practices have also being questioned in Australia and other places. But those claims can only taint the reputation of the company.

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After years of push and pull, Shire PLC (ADR) (NASDAQ:SHPG) can now rest easy. The company announced that Judge Donald Middlebrooks of U.S. district court of Southern Florida ruled that Allergan’s division Watson had violated patent protection for Lialda. The drug is targeted at inflammatory bowel conditions.

Marketing exclusivity until 2020

The ruling now means that Allergan’s Watson unit cannot sell a generic competitor to Shire Lialda. The drug will enjoy marketing exclusivity in the U.S. until 2020.

Shire PLC (ADR) (NASDAQ:SHPG) had accused Watson of infringing at least two claims of Lialda’s patent. It’s been a long legal battle moving from U.S. district court to appeals court and to the Supreme Court and back to district court.

Back and forth case

After the appeals court in March 2014 threw out a ruling by a district court in favor of Shire regarding Lialda, the case proceeded to the Supreme Court. But the highest court in the land referred the matter back to a lower court where proceedings continued until the latest verdict that has come in favor of Shire.

More than $684 million in sales

Shire’s Lialda was approved in the U.S. in 2007, but it was threatened by early loss of patent protection s Allergan sought to introduce a generic rival. Lialda generated $684.4 million in revenue in 2015, thus contributing nearly 11% of the $6.1 billion that Shire generated in total sales in the year.

According to Shire PLC (ADR) (NASDAQ:SHPG), the upholding of its patent claims for Lialda comes as a support for the innovation it has continued to deliver to patients.

One of a kind

Shire’s Lialda is said to be the only once-daily mesalamine-based drug administered for both maintenance of ulcerative colitis remission and induction of remission of mild/moderate ulcerative colitis.

Pressure on specialty medicine developers

The favorable ruling should at least calm investors who were getting worried about tightening business atmosphere for makers of specialty medicines. Political pressure over high costs of specialty drugs and growing generic competition has battered the stocks of Shire PLC (ADR) (NASDAQ:SHPG) and its peers in the recent months.

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Pimavanserin, to be marketed as Nuplazid, received overwhelming advisory panel backing. The panel voted 12 to 2 in favor of the drug.

Following the verdict of the outside advisory committee, the FDA is expected to make its final decision on the drug by May 1. It is worth pointing out that the FDA doesn’t have to follow the recommendation of its outside advisors, but it typically does so. That is why following the advisory panel’s verdict on the drug candidate, optimism has increased that Acadia Pharmaceuticals Inc. (NASDAQ:ACAD)’s antipsychotic drug could be heated for FDA approval.

Accelerated review

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD)’s Nuplazid is already in good FDA books. The agency has granted the drug “breakthrough therapy” designation, which warrants accelerated review by the regulator.

The problem at hand

It is estimated that about 60% of people suffering from Parkinson’s disease will develop psychosis problem if their condition progresses. But psychosis will complicate matters for those victims because it raises mortality rates.

The reason Acadia’s Nuplazid could be a compromise despite its other risk issues is that existing antipsychotics treatments tend to undo the benefits of medication targeting the underlying disease.

What did the trial show?

According to Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), its trials of pimavanserin showed that the drug improved the quality of daytime wakefulness and nighttime sleep. Additionally, the drug helped relieve the burden on caregivers.

The fact that there isn’t an approved treatment for psychosis is one major reason that influenced favorable verdict on Nuplazid before the advisory committee.

Although there are clear risk issues regarding Nuplazid, the panel felt it was important to approve the treatment now and demand that the developer improve its safety later.

Revenue potential

If approved, analysts estimate that Acadia Pharmaceuticals Inc. (NASDAQ:ACAD)’s Nuplazid could hit $1.4 billion in revenue by 2020. That puts it among the potential blockbuster drugs seeking the FDA nod this year.

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That means that in just about a month, Alexza Pharmaceuticals, Inc. (NASDAQ:ALXA) could be forced to shutter operations. To avoid going out of business for lack of funds to run operations, Alexza’s management is in talks with a partner in what could culminate in total acquisition of the broke biotech.

Total buyout

The partner that Alexza is in financing and buyout discussions with is Grupo Ferrer, a Spanish biopharma. Alexza is trying to shop itself to Grupo Ferrer in a deal that could see all its outstanding common stock acquired by the Spanish drug company. However, so far no decision has been reached in the talks and there is no guarantee such as a deal could materialize. Alexza has a market cap of about $9.3 million, which appears palatable for Grupo Ferrer if it were interested in acquiring the struggling biotech.

Alexza recently draw $1 million from Grupo Ferrer under a promissory note arrangement between the two entities.

Austerity measures

According to Alexza Pharmaceuticals, Inc. (NASDAQ:ALXA)’s CEO, Thomas King, the last six months have seen the company tighten its belt, especially cutting costs, seeking additional financing and repositioning the management team. Although Alexza has tried to cut cost in the recent months to at least squeeze the most out of its thin cash base, it will have exhausted all its financial resources by the end of April. Only additional funding could keep the company in business.

4Q2015 highlight

Alexza Pharmaceuticals, Inc. (NASDAQ:ALXA) posted 4Q2015 revenue of $673,000, a sharp decline from $1.5 million in a similar quarter a year earlier. However, net loss of $3 million was down from $6.7 million in the previous year.

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On an adjusted year-over-year basis, Allergan plc (NYSE:AGN)’s Saunders earned a hefty cash payout in 2015 compared to 2014, thanks in part to merger successes. For example, incentive pay in 2015 rose sharply to $20.2 million from a paltry $1.54 million in the prior year.

Merger success

Saunders’s incentive pay spiked courtesy of a $6 million award based on the financial performance of Allergan that met the target. Another $14.25 million came through awards related to merger success. In particular, Saunders helped Allergen to hit the cost-saving targets post combination with Forest Laboratories. The merger success also saw several other C-suite executives at Allergan walk home with significant incentive payouts.

Saunders’ base salary in 2015 doubled relative to 2014 figure to $1 million. The CEO’s other perks also rose compared to the previous year. For example, entitlement to company aircraft, personal car and a driver increased to $315,325 in 2015 compared to only $55,187 in 2014.

What next for Saunders?

It is uncertain what impact the pending combination of Allergan plc (NYSE:AGN) and Pfizer Inc. (NYSE:PFE) might have on Saunders’ paycheck. Saunders is poised to become the COO of the combined company. Pfizer is seeking marriage with Allergan in a deal that would see $160 billion change hands between the two drug companies.

However, post the merger with Allergan plc (NYSE:AGN), Pfizer is expected to embark on a breakup process, possibly splitting into two standalone corporate entities. Saunders could become the CEO of one of the two resulting companies when Pfizer splits up itself.

The post Allergan Plc (NYSE:AGN)’S CEO Saunders Takes Home $21.6 Million In Compensations appeared first on Sonoran Weekly Review.

Aphaeresis is describes as an invasive, costly and time-consuming therapy. It costs patients in the U.S. $100,000 to undergo a specializedaphaeresistreatment to remove high levels of bad cholesterol from their blood.

In the Phase 3 study of Praluent, Sanofi SA (ADR)(NYSE:SNY)and Regeneron focused on patients who needed aphaeresis therapy on a weekly or fortnight basis. To test the effectiveness of Praluent, some patients added the drug to their bad cholesterol treatment regimen while a control group was given placebo.

Remarkable results

At the end of the trial, 75% of the patients who added Praluent as part of their treatment registered a 75% drop in the frequency of aphaeresis therapies they needed as determined by bad cholesterol in their blood.

After further analysis, Sanofi SA (ADR)(NYSE:SNY)and Regeneron reported that it turned out that actually 65% of patients in the Praluent group didn’t need aphaeresis. But none in the placebo group could afford to stop receiving aphaeresis treatment.

The study focus

The late-stage study of Praluent in patients with a severe form of bad cholesterol was conducted in 62 patients. The study ran for 18 weeks in both the U.S. and Germany. The two countries were selected because they have higher number of LDL aphaeresis treatments.

Costly therapy

According to Regeneron’s VP, Bill Sasiela, Praluent has become the first PCSK9 inhibitor to show that it can significantly lower the frequency of apheresis therapy. The findings point to a remarkably promising future for Praluent and LDL sufferers.

In the U.S., apheresis therapy costs up to $100,000 and it Germany the costs run to €60,000. In contrast, Praluent costs $14,000 per year.

As such, there is a fair chance payers and doctors may favor Sanofi SA (ADR)(NYSE:SNY) and Regeneron’sPraluent to help lower the costs of aphaeresis treatments.

The post Sanofi SA (ADR)(NYSE:SNY), Regeneron (REGN) post remarkable Praluent Phase 3 findings appeared first on Sonoran Weekly Review.

Investors responded positively to Alder’s positive clinical results for ALD-403, pushing the stock up nearly 50% at the close of the previous session.

Target met

The clinical trial results that Alder Biopharmaceuticals Inc (NASDAQ:ALDR) obtained from the Phase IIb study of ALD-403 met its primary endpoint target. With that, Alder can now take the drug candidate to the next level of trialing as it draws closer to seeking marketing approval for it.

What was the study about?

The aim of Alder’s mid-stage trial of ALD-403 was to determine its effectiveness in combating migraine compared with placebo.

What were the results?

The study results showed that 31% of patients placed on 100-mg dose experienced a 75% decline in migraine days over period of 12 weeks. In the 300-mg group, 33% of patients taking the ALD-403 also showed 75% reduction in their migraine days over a 12-week period. In the placebo group, 21% also showed a 75% decline in migraine days over a period of 12 weeks.

The remarkable clinical results are both a positive for ALD-403 developer Alder Biopharmaceuticals Inc (NASDAQ:ALDR) and victims of migraine. There are about 13 million people in the U.S. suffering from migraine and about 3 million of them suffer from chronic migraine.

Leading name in the pipeline

Alder is a clinical-stage biopharmaceutical company and ALD-403 is its most advanced drug candidate. The company will be meeting with FDA to discuss the results of its mid-stage clinical trial of ALD-403. Meanwhile, it has already kicked off recruitment of patients for a Phase 3 study of the drug candidate. Another Phase 3 study of ALD-403 is expected to kick off later this year.

Potential risks

Anything can change the course of a drug candidate in clinical trial phase. However, Alder Biopharmaceuticals Inc (NASDAQ:ALDR)’s ALD-403 is heading into the next phase of trial with solid mid-stage data.

Besides the uncertainty of clinical trials, Alder will have to face larger rivals such as Eli Lilly and Co (NYSE:LLY), Amgen, Inc. (NASDAQ:AMGN) and Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) in the contest for the calcitonin gene-related peptide (CGRP) therapy market.

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Bayer AG (ADR)(OTCMKTS:BAYRY) and Regeneron are joining hands to develop combination eye treatments based on certain complex compounds known as nesvacumab and aflibercept. Nesvacumab is described as an angiopoietin-2 (Ang2)antibody while aflibercept as a vascular endothelial growth factor (VEGF).

Positive early findings

Pre-clinical trial results have shown that combination of angiopoietins and the VEGF family boosts growth of lymphatic and blood vessels of the eye.

If the program succeeds, Bayer AG (ADR)(OTCMKTS:BAYRY) will have claim to 50% of the profits from the sale of the combination eye drugs outside the U.S.Regeneron will retain 100% of the profits of the drugs generated in the U.S.

$130 million investment

Bayer is paying $50 million upfront to Regeneron. The balance of $80 million will be released upon attainment of certain milestones.

Sales up 54%

Bayer is hoping that the new alliance with Regeneron will be as successful as Eylea. Sales of Eylea were reported at $2.68 billion in 2015, indicating an increase of 54% from 2014 numbers. The spike in Eylea sales were attributed to the drug’s success in clawing away market share from Roche’s Lucentis in the diabetic macular edema (DME) field.

Eye treatment market

Eye disease market is rapidly expanding. Therefore, success of the new collaboration with Regeneron could unlock huge profits for Bayer AG (ADR)(OTCMKTS:BAYRY) in the coming years. The fact that the search for the advanced eye treatments is based on highly successful profits raises the prospects of success.

Regeneron on its part is hoping that new alliance with Bayer AG (ADR)(OTCMKTS:BAYRY) will provide another much-needed boost to its search for solutions to the problem of vision loss, which is a devastating condition.

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Although Roche Holding Ltd. (ADR)(OTCMKTS:RHHBY)’s Schwan took home more than his Novartis counterpart last year, his total compensation didn’t change much from the previous year. For example, his salary was unchanged at 4 million francs. Stock compensation awards were a little more than 2.6 million francs. However, compensation under restricted stock was down to 781,658 francs.

Double bonus

It was double increase in Schwan’s bonus at 3.13 million francs that significantly boosted in 2015 total compensation. Bonus in 2014 was just 1.34 million francs. But declines in performance share-based plan awards offset the sharp increase in bonus.

Compared with Schwan’s total compensation for 2015, Jimenez of Novartis took home 400,000 francs less. Troubles in the emerging markets such as Venezuela and with its eye unit Alcon complicated the picture for Novartis in 2015, thus adversely impacting the company’s performance and CEO’s compensation. In Venezuela, it was currency devaluation that hit Novartis’ bottom-line.

How did Roche perform?

Roche Holding Ltd. (ADR)(OTCMKTS:RHHBY)’s 2015 sales grew 5% to 48.1 billion francs but earnings disappointed as they declined to 13.49 francs a share. However, 2016 could be a tough year for Roche as it will face increased competition from biosimilars for its major drugs Rituxan and Herceptin.

U.S, CEOs take home fatter paychecks

Both Roche Holding Ltd. (ADR)(OTCMKTS:RHHBY) and Novartis CEOs earned much less than their U.S. counterparts in 2015. For example, Johnson & Johnson (NYSE:JNJ)’s CEO Alex Gorsky took home $23.8 million in 2015, which actually down from $25 million in the previous year. AbbVie Inc (NYSE:ABBV)’s chief Richard Gonzalez earned more than $20 million in 2015.

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Allegations against Abbott

At the center of the $1 billion lawsuits is the use if bile duct stents. The salesman turned whistleblower says Abbott used biliary stents in vascular arteries, yet they were intended for short-term purposes. The company will have to defend itself against allegations it sought to increase sales through marketing yet it knew very well the FDA had not approved them.

Colquitt maintains Abbott actions amounted to mass experimentation on senior citizens. Citing a case where a man lost his leg and, later on, died following the implantation, the plaintiff says the company should be made to account for its actions.

Abbott’s Defense

Abbott also faces allegations that it engaged in false advertising and paying physicians to train doctors about the use of the device. The company on its defense says the use of stents was a standard care at the time as it could have taken six years for them to be approved by the FDA.

Abbott has already refuted allegations saying the lawsuit is only trying to rewrite history. In its defense, the company says the government decided to reimburse for the off-label use of stents.

“Doctors demanded the latest and best technology for their patients. Biliary stents provided the latest technology,” said Abbott lawyer James Hurst

In 2006, Colquitt sued the company but at the time the Fed were not part of the case. In 2013, Abbott reached a $5.5 million settlement with the federal government over off-label marketing. In the current $1 billion case should he win, most of the money will go to the government. However, he is still entitled a share of the money as a whistleblower.

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As per the SEC, the Chinese units of Novartis as well as its generics venture, Sandoz listed illicit cause as legitimate expenditures. For example, two sales representatives at Sandoz China listed $8100 in expenditure vetted by a regional sales manager that was for entertainment as well as gifts for healthcare personnel.

SEC stated that Novartis did not create and retain an effective system of controlling internal accounts or a potent anti-corruption adherence program. In an email Novartis stated, that the SEC raised issues which go back up to 2009 and come before several of the compliance measures put by Novartis across its worldwide presence in current years.

The SEC observed that Novartis introduced an internal review of its Chinese operation in 2013. It identified potentially questionable activity and reformed its relationships with event planners and more. It also enhanced internal controls and dismissed or disciplined certain employees.

The Novartis settlement involves a $21 million payout, $2 million in civil penalties and an interest of $1.47 million. The company did not admit to any illegal activities as part of the deal.

Currently, SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) assented to shell out $12.8 million to settle an SEC investigation into alleged violation. In 2015, Bristol-Myers Squibb shelled out $14 million for bribery cases in China.

The larger settlement and the biggest example of bribery in China was the $489 million fine imposed on GlaxoSmithKline in 2014. This came after a probe into hundreds of millions in incentives for doctors as well as other healthcare personnel’s, several of them listed as travel and meeting expenditure.The charges are similar to those against a number of other pharma companies that have settled similar probes by the American government as well as foreign agencies.

In 2012, Eli Lilly and Co (NYSE:LLY), assented to pay over $29 million to settle allegation of bribing foreign government personnel to get business in many nations. Also in 2011, Johnson & Johnson had to pay $70 million for FCPA violations.

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But Joe Jimenez Novartis AG (ADR) (NYSE:NVS) Novartis’ CEO has nothing to celebrate regarding compensation because Schwan’s 2015 compensation was way above his with about 400,000 Swiss francs. Nevertheless, Novartis has blamed it on the troubles suffered by its eye unit Alcon as well as the emerging markets sales whereby Venezuela took a big bite out of revenue than it could handle.

Nevertheless, the compensation packages for the two CEO’s are still below par compared to their U.S.-based biopharma rivals. Some of the comparisons include Chief Richard Gonzalez, AbbVie Inc (NYSE:ABBV) whose 2015 compensation was more than $20 million and even if it was lower than the $22 million reported in 2014, Jimenez and Schwan were not anywhere near any of these figures. Another comparison is that of Johnson & Johnson (NYSE:JNJ) Chief Alex Gorsky, who bagged a $23.8 million, down from $25 million in 2014.

Roche’s 2015 sales growth gained overall revenue of 5% to 48.1 billion francs for the year. However, the earning suffered a decline of 13.49 francs per share. But even with all these occurrences, the company ought to be put its house in order as it approaches the upcoming biosimilar competition from Rituxan and Herceptin. It is also anticipating two full approvals of multiple sclerosis med ocrelizumab and immuno-oncology treatment atezolizumab.

Venetoclax, a leukemia treatment and which is co-developed with AbbVie is also awaiting the FDA’s approval later in the year with sales expected to hit $1.5 billion by 2020.

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Analyst’s predictions are that by 2020, the anti-inflammatory drug which joins the competition wave of rivals the likes of therapies for psoriasis should be able to gain a share of the market that is already worth billions of dollars. It is only through this that the pharma giant will be able to bounce back to its glory after its profound experience in 2014.

More often than not Lilly has found itself being in competition with heavyweight, but somehow it ends up to win the approval. And true to this, a while ago it obtained approval for the therapy which gives it more hope of being part of the big market later in the year. And yes it is likely to follow up with a market-expanding approval for psoriatic arthritis having taken up the footsteps of Cosentyx, the first IL-17A drug to hit the market which resulted from Novartis’ approval.

According to Julie Beitz, from the FDA’s Office of Drug Evaluation, the drug’s approval is such a great milestone for many patients that have been suffering from plaque psoriasis. The drug provides an option that helps in relieve of skin irritation and distress from the condition. Beitz’s sentiments received affirmation from Alex Azar, president, Lilly USA, who expressed the companies pride in being able to provide patients and dermatologists with a new choice of medication that will provide a notable improvement of psoriasis plaques.

But how does Taltz? It simply blocks the protein that causes inflammation and which leads to the development of the autoimmune disorder. The inflammation results in red skin, thick, unsightly, and scaly white patches. Nevertheless, Lily has confirmed that it is not about to release the price list until the actual market launch.

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Out of this disappointment, the agency declined to recommend the cystic fibrosis med which facilitates the reduction of hospitalizations when patients’ symptoms suddenly get worse. In any case, Director Carole Longson says that the funding is only restricted to treatments that are fully effective, beneficial to the patients and should be of good value for money.

Nevertheless, the drug is said to have some benefits from lung function.

The drug got its approval last year, and the company promised to roll out a list price for the med of $259,000 annually. Apparently, this is not the first time that Orkambi is suffering price related setbacks. Vertex has this far agitated the payers and other pricing critics having fallen off from analysts’ expectations.

Expressing the agitation, Paul Quinton, who is the professor of biomedical science at the University of California at San Diego said that what the company had done was unpleasant. Their price is five times more the yearly salary of the average American family hence it is unfair to charge that much.

But in hot pursuit of defense, Vertex is clinging on the drugs advantages to justify the highly rated price. Compared to the company’s first CF treatment, Kalydeco, the company argues that Orkambi meets the treatment needs of a broader patient population.

A further argument illustrates that the company drug which brought in $220 million last year spent a massive amount of time and money to bring the drug into the market before obtaining its approval in July.

Nevertheless, despite all these hurdles, Vertex COO Stuart Arbuckle says that the company is still counting on Orkambi to drive massive growth margins. And with all these optimism, it is likely that Vertex will not embrace the takeover bids from deal-hungry rivals the likes of Gilead Sciences, Inc. (NASDAQ:GILD). Instead, it is opting to embrace the solo act life.

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The adjusting of Medtronic’s operating margin has angered investors who claim that it is was way below expectation in Q3 FY 2016 probably due to an underperformance in synergies from the Covidien integration effort.

However, Medtronic officials have defended the company arguing that it is steady enough to remain on track and will be able to meet and eventually exceed its $850 million synergy target from the Covidien deal by the end of FY2018. And according to CEO Omar Ishrak the plan which is expected to be completed in 2019 is all about preservation, optimization, acceleration and the dire need for transformation.

Ishrak reveals that the company is also laying out other strategies that will improve efficiency. Some of these strategies include integration of sales force, getting back to the drawing board with suppliers and vendors to renegotiate on prices as well as scrapping off duplicitous positions that either not necessary or have duplicated roles.

In a Barclays Global Healthcare Conference that took place earlier in the month, the CEO stated that the removal of sales related expenses has saved the company a good amount of savings and that the integration of corporate information technology will also come in handy for future savings. Nevertheless, the manufacturing consolidation benefits will be realized a little later perhaps in FY 2017 and more in FY 2018.

Sometimes in December, the company expressed its desire to build a €13 million ($14.3 million) facility in Galway in a bid to achieve those synergies in Ireland. The facility will facilitate the manufacturing of fast-selling In.Pact Admiral drug-coated balloon for peripheral artery disease.

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In its lawsuit, Lilly’s insurer, National Union of Pittsburgh is pointing fingers at ADT/Tyco security firm from it is trying to recover about $42 million. A lot of questions have been asked about the drug makers’ safety and how best they can protect their supply chains.

Brothers Amaury and Amed Villa have been mentioned widely in the lawsuit as the gangs who through the weak points of the warehouse gained access to the company’s assessment and carried out the vandalism act. The duo must have used an unprotected spot in the store roof whereby, they went undetected by monitoring equipment hence they easily disabled security and telecommunications systems.

And it seems like burglary is in the villa brother’s blood because which suspect ever pleads guilty to whatever charges even after being caught red-handed? Well, these twos have pleaded guilty and besides, they are among a set of other 23 suspects arrested with cargo theft related incidences and whose evidence was left at one of the scenes.

ADT/Tyco is now on the receiving end to explain what exactly happened and how the rate occurred? There are so many questions hanging in the balance. And apparently, the complaint has also stated that there are many other sites whose security watch is under the mentioned security firm hence they could be vulnerable to burglaries.

In his argument Elisa Gilbert, a lawyer for insurer says to conclude that either the gang was given direct access to the facility or there was a weak link that they were able to hack.

And following Lilly’s break-ins, various companies within the pharma industry have teamed up to lay out strategies on how to fight cargo theft.

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According to the head of Vaccines Research & Development at Pfizer, Kathrin U. Jansen the recent past has experienced exceptional technological advances in the understanding of the biology of diseases. And in as much as this has led to the redesigning of new vaccines, the conversion from preclinical to vaccine clinical research has suffered the lack of understanding of the desired human immune responses required to facilitate optimal vaccine protection.

Vaccine development is more often than not faced with the lack of indulgent of the rules of effective immunity. Hence, the application of latest biomedical technologies is expected to place the public-private consortium a notch higher into being able to identify the fundamentals of immunological protection. After all, they will lead to the development of new and improved diagnostics, vaccines and immunotherapies.

In support of the Human Vaccines Project, its founder Wayne C. Koff explains the need for the human immune system being able to hold onto the prevention and control of a broad spectrum of infectious diseases and other allergies. The need results into bringing together of prominent vaccine researchers, institutions, and biopharmaceutical companies that will help in yoking the latest technological advances.

It is Pfizer’s desire to bring closer to the people safety, value and quality standard of healthcare products. Its everyday work involves development and merging of markets to advance wellness, prevention, treatments and cures. Consistency and responsibility make it one of the world’s premier innovative biopharmaceutical companies and in collaboration with other health care providers, governments and local communities it can provide steadfastly and reasonably priced health care around the world.

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Earlier on, analyst Chardan’s Gbola Amusa had given a prediction that Sanofi and Regeneron could pay hefty royalties to Amgen on its PCSK9 drug Praluent. Amusa now says that there is a likelihood that the potential blockbuster may be thrown out of the market. And going by his investor note, there have been consultative meeting with the relevant parties including legal counsel.

Nevertheless, Sanofi and Regeneron have vowed to appeal regardless of the fact that the appeal process takes ages to complete. On the other hand, Amgen is also seeking a permanent injunction on the kicking out of Praluent, which would give Repatha a head to head on competition.

Well, there are different opinions about Amgen’s bid for an injunction. A click of analysts has expressed its likeliness in failing but at the same time, they have given an indication of there being a deal for royalties from Sanofi and Regeneron. The fees are expected to range from 5% to 20%.

But Amusa will not agree with the analysts’ views citing that overrated optimism. The analysis chooses to stand his ground that the court ruling is likely to kick out Praluent from the US market. Nevertheless, the hearing is coming up soon, and it is only then that outcome of the hard-fought dispute could be known.

In the meantime, the rivalry battle between Praluent and Repatha for market share continues. Apparently, the two launched within a month of each other but even with this they are both agonizing in exclusive deals with some payers.

The sad part is that the sales are facing challenges are yet to take off. The main hurdle is that patients have to be cleared out before obtaining their prescriptions a process that is rather cumbersome. On the other hand, evidence as yet that the drugs can be used in the averting of heart attacks, strokes and the like even though word has it that competent in lowering “bad” LDL cholesterol.

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The two companies’ motive is to cut its $160 billion tax burden, but Sanders has referred to Pfizer’s inversion maneuver a “tax scam.” He is now calling on Treasury Secretary Jack Lew to make use of his unexploited authority and undermine the deal by probably removing some of the tax strategies. Sanders argument is that a lot of companies are using the so-called tax inversions return offshore profits to shareholders and blocking them would be the only way to deter other companies from carrying out the same activities.

And besides the pressure to Lew to exercise his authority, Sanders is also urging the Congress to enact legislation that would help in halting corporate inversions. In his letter, Sanders states that Pfizer and other large corporations should be not be let off the hook of paying taxes pointing out that the stoppage of the merger would earn the U.S an estimate of $35 billion in lost taxes. However, these estimates are questionable according to economists.

The Treasury has since acknowledged having received Sander’s letter and has promised to respond in due time. Pfizer’s tax-avoidance scheme is also under condemned by Sanders’ rival for the Democratic nomination Hillary Clinton as well as Republican front-runner Donald Trump.

On the other Pfizer argues that its merger to Allergan will heighten the company’s research and development capabilities. In the long term, it will be able to sustain the growth of the innovative business.

In 2014, Pfizer had approached London-based AstraZeneca plc (ADR) (NYSE:AZN) seeking a merger. However, AstraZeneca declined the proposal citing a low offer by Pfizer.

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And after a long thought, it has emerged that NICE has agreed to fund the medication but on condition that J&J promises to offer relevant discounts. Another thing that would sway the cost watchdogs into action would be the reduction of Zytiga’s prices to £2,300 for 120 tablets from £2,930.

Apparently, new data from Janssen reveals that 14% of patients in the U.S who used Zytiga held up to the treatment for more than four years. It is probably this revelation that has moved NICE to make its decision and has since promised to back Zytiga for men with metastatic prostate cancer (mCRPC). NICE Director Carole Longson has referred to this as good news bearing in mind that there are very few treatment options for patients at this stage of prostate cancer hence the more need to recommend Zytiga.

Previously NICE and J&J have had an antagonistic relationship over Zytiga. However, this now seems to be in the past and is probably not relevant at this point.

The decision by NICE means that patients in England will now be able to access consistently the innovative cancer medicine, a move that has been well received by Mark Hicken, Janssen U.K., and Ireland Managing Director.

The intent by NICE to back Zytiga comes at a time when the drug is in stiff competition with prostate cancer med Xtandi from Medivation Inc (NASDAQ:MDVN). Zytiga is now trying to defend its market share following the December backup of Xtandi from NICE for its pre-chemo settings.

Well, analysts say that Zytiga may receive an upper hand in the market but on the contrary they have claimed Xtandi will overshadow it very fast since it has the convenience of being taken as pill, unlike Zytiga which must be accompanied by prednisone. Additionally, a lot of oncologists prefer Xtandi because of its post-chemo setting.

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In comparison with placebo, the antibody commonly referred to as room is way above having achieved its Phase III BRIDGE study primary endpoint of being able to increase bone mineral density (BMD) of the lumbar spine in a span of 12 months. Besides, records reveal that the drug which is trying to outdo blockbuster Forteo from Eli Lilly and Co (NYSE:LLY) is also ahead with its secondary endpoints of bone mineral density (BMD) increase of femoral neck.

Earlier on, the company announced positive results for its new bone drug in its FRAME study for women even though according to analysts, the drug did not execute good results as its primary late-stage rival at Radius Health Inc (NASDAQ:RDUS). Radius is now looking forward to filing for an endorsement from the FDA as well as approval from EU.

Nevertheless, Amgen’s treatment has an upper hand regarding administration compared to Radius’ drug. The latter’s administration is injected daily while that of Amgen is only once a month.

But even with Amgen’s of having beaten Lilly’s drug in a head-to-head study in women, there are many questions concerning how Romo data compares with Forteo for men simply because Amgen has not released any specific values for the magnitude of BMD increase in the BRIDGE study data. Analysts at Leerink Swann say that this will make its marketability pretty hard.

Apparently, the Romo data has revealed an increased amount of cardiovascular serious adverse events which could easily lead to a usage limit due to potential risks.

However, its defense, Amgen has said that there is an on-going BRIDGE study data analysis but will not reveal when it is likely to be surrendered to a future medical conference and for publication. The company is also optimistic about being able to hold talks with global regulators to discuss the results though it was non-committal of when the talks would take place.

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However, Samsung has denied any truth within the speculations and has outlined the non-existence of formal discussions about a partnership. The only thing that Samsung has clarified is the possibility of working together in the future.

But was the visit alone an adequate hint to spark such speculations? Yes, It was because other reports indicate that Lilly might be considering a move into the field of biosimilars. In any case, the company won the FDA’s endorsement for a Boehringer Ingelheim an affiliated take on Sanofi’s Sanofi SA (ADR) (NYSE:SNY) blockbuster insulin Lantus.

With the facilitation of Biogen Inc (NASDAQ:BIIB), Samsung Bioepis’s formation was founded in 2011, and the company has since built up a broad pipeline of biosimilars. And right to this word, last year, the company obtained its first approval with the European clearance of its version of Amgen, Inc. (NASDAQ:AMGN) alongside blockbuster Enbrel from Pfizer Inc (NYSE:PFE).

Well, the company seems to be going places which can be affirmed by it’s already U.S. pharma partner in the form of Merck & Co., Inc. (NYSE:MRK). Nevertheless, there are challenges regarding licenses deals which dictate that the American drugmaker’s rights Samsung Bioepis’ products are only restricted to certain territories.

And in other news, many companies are looking up to working with big time biologics the likes of Novartis AG (ADR) (NYSE:NVS) and Pfizer and Amgen and from where they expect to siphon profits. And there are chances that biosimilars being the cheaper alternatives to expensive therapies will change the landscape in biopharma even though there will be a loss of $110 billion in sales in branded biologics to copycats according to Citigroup analysts.

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Reliable sources and which cannot be named revealed the likelihood of Sanofi’s movement of its headquarters to Gentilly in Paris where the company already has offices. And according to one person the company which has about 700 workers would save millions of euros.

At the point of joining the company one year ago, Brandicourt promised to make cuts as part of a €1.5 billion reduction in costs ($1.6 billion). And in seeking ways and means of cutting costs, sources say that the top management is working towards elimination of management layers, simplification of operations and cutting positions in France. Brandicourt is doing all this to restoring Sanofi’s fortunes which will help in sustaining its earnings growth through 2020.

But in a new twist of events, the company has denied the information citing it as false while at the same time indicating that Sanofi does not have anything to do with the information published by Bloomgerg.

The maker of blockbuster Lantus has been dragging in its sales of its prized diabetes franchise due to financial pressure. Brandicourt’s thoughts of helping the drugmaker get back to its operations through the half dozen of drugs were shattered earlier on after Sanofi and partner Regeneron Pharmaceuticals Inc (NASDAQ:REGN) lost to Amgen, Inc. (NASDAQ:AM).

Sanofi and Regeneron have been battling it out over their competing cholesterol drugs and particularly Praluent. The blow to the two came in when a U.S. jury found that the said drug had dishonored various copyrights on a rival PCSK9 drug from Amgen. Apparently, this is one of the drugs that Sanofi is looking up to, reviving its sales and if the decision holds, the company will have to face the payment of royalties.

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The halt comes at a time when the company is working on rebuilding itself in other therapeutic areas the likes of cancer and when the competition of its hepatitis C drugs is at its peak. Gilead is also suffering another setback; the departure of oncology head Philippe Bishop. The former scientist at Genentech has been directing the clinical the development of Gilead’s cancer drug pipeline since December 2014.

Bishop has been at the helm of developing some of the company’s most successful products the likes of the breast cancer drug Avastin and Perjeta, the and cancer med Kadcyla.

Well, according to Gilead’s Chief Scientific Officer Norbert Bischofberger Bishop’s stay with Gilead was a short stay but he further expounds that his departure was collectively agreed upon, and it was for the best. Nevertheless, with the entry of Mr. McHutchison who now heads the company’s oncology pipeline, Bischofberger says that the firm’s future in oncology is still bright.

Bischofberger has further reported of the company’s interest in immuno-oncology but with a condition of having a true differentiation compound what is in the market or its final stages of clinical studies. It is now offering itself for large and small deals as it tries to play a catch-up act with Merck & Co., Inc. (NYSE:MRK) and Bristol-Myers Squibb Co (NYSE: BMY) which have commercialized their treatments.

Nevertheless, the new CEO John Milligan has promised a new face for the company and despite Bishop’s exit the, it will still hold up to oncology. After all, it is only two years ago when the company won approval for its lead hep C drug, Sovaldi.

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Uncertain Future

McKesson says it informed its staff of the imminent cuts in March. All affected employees are entitled to severance benefits as well as outplacement services. It is hoping to use the cuts to align its cost structure with its business needs

McKesson Corporation(NYSE:MCK) shares have lost more than 30% in market value over the past 12 months which has since prompted a strategic review of its operations.

The wholesale distributor has already warned that its earnings going forward could be weighed down by the expiry of big contracts. Benefits Manager Optum has yet to make a decision on whether it will renew an ongoing contract. Changes in contract with Omnicare and Target could also come to haunt the company’s bottom line.

Sector Consolidation

The company has not had the best of runs in the recent past having already slashed its outlook for the current fiscal year that ends March 31. It has also issued a downbeat outlook for the next fiscal year as it remains wary of a choppy market.

A wave of consolidation and expiration of big contracts in the sector continues to deal the company a big blow. Rite Aid Corporation (NYSE:RAD), which is one of the company’s biggest trading partners, is in the process of being acquired by Walgreens. It awaits to be seen the kind of impact the merger will have on the ongoing partnership considering Walgreens Boots Alliance Inc (NASDAQ:WBA) works with some of McKesson’s competitors

McKesson Corporation (NYSE:MCK) has in the recent past tried to reinvigorate its prospects in the business through acquisitions. Early this month it acquired Canada’s No 2 drug store Chain Rexall Health in a deal worth $2.23 billion. The takeover followed the purchase of two oncology companies in February that cost the company $1.2 billion.

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 What to Expect At JLINX

Dubbed JLINX, the new site will operate just like other JLABS sites operated by Johnson &Johnson (NYSE:JNJ) in the US. Invited startups will be able to access state of the art laboratory equipment. Research and Development support will also be on offer as well as VC funding.

Johnson &Johnson (NYSE:JNJ) is currently trying to raise more cash from external investors as it looks to lure more startups into the platform. Companies accepted into the incubator will be able to apply for funding without having to worry about their final products being tied to the company. By doing so, the company hopes to entice more startups to sign up.

Infrastructure that startups can access will come from Johnson & Johnson’ Jansen Subsidiary. Other facilities from the company’s broader network will also be on offer. Creating a vibrant ecosystem where startups with similar objectives can interact is the company’s primary goal with the initiative. Johnson & Johnson plans to offer startups flexible ways of growing while leveraging the vast European life science ecosystem

 Fueling Europe Startup Culture

Johnson &Johnson (NYSE:JNJ) hopes to spur a creative startup culture in Europe by providing entrepreneurs and startups access to world-class expertise and technology. The company is currently accepting application ahead of the opening of the facility in the summer.

The biotech Incubator will be opened to all companies working on human health while also targeting areas of innovation on pharmaceuticals. Johnson & Johnson (NYSE:JNJ) plans to give priority to microbiome startups. Bioqube Ventures has been selected to oversee selection of startups that will join the initiative. It will also oversee the allocation of VC funding and the setting up of a team that that will handle the site’s day to day operations.

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Primary Goal

By collaborating, the two hope to optimize the manufacture and delivery of personalized therapies by leveraging each other’s cutting edge processing technology. GlaxoSmithKline plc (ADR) (NYSE:GSK) brings to the table expertise that should be helpful in the development of cell and gene therapy based treatments. Miltenyi Biotech, on the other hand, should bolster the partnership cell processing capabilities by making available related technologies in cell therapy.

The partnership primary goal is to spearhead efforts on the discovery of new chimeric antigen-receptor T-cell based therapeutics. These kinds of cells target and destroys cancer cell by stretching patient’s natural T-cell responses.

The likes of Pfizer, Novartis, and Juno Therapeutics are also spearheading efforts on this front. Trial results on this area of treatment have been impressive, but no company has yet to chart a strong signal of efficacy more so on solid tumors. GlaxoSmithKline plc (ADR) (NYSE:GSK) and Miltenyi remain quite on which CAR-T oncology targets they are working on.

GlaxoSmithKline plc (ADR) (NYSE:GSK) latest deal builds on a similar deal with Philadelphia-based Adaptimmune that continue to target certain oncology targets. The   British company is using such partnerships to bolster its cancer drug portfolio having sold part of the unit to Novartis for $20 billion last year.

Witty’s Exit

Even as GSK tries to bolster its oncology portfolio investors focus shifts to finding a replacement for current CEO, Sir Andrew Witty. The Chief executive is to step down next year after 32 years of service. The pharmaceutical giant has already begun formal search for his successor.

Witty’s departure has long been coming Chairman Philip Hampton having spoken about the same last year. The last three years have not been easy for the chief executive, GlaxoSmithKline plc (ADR) (NYSE:GSK) having faced stiff competition from cheaper generic drugs. The company’s woes have further been compounded by the expiry of patent protection for key drugs.

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Mr. Witty has been the company’s CEO since 2008 and he will leave a mark that spans almost ten years in the company. His exit will pave way for a new CEO who will take the firm to new heights and GSK has already announced that it is looking for potential successors. There has been rumors that Witty will soon leave the firm because investors have been lobbying for changes in leadership. His departure was warranted by declining sales in the company’s major offerings.

Despite the push for his exit, Witty does not seem to be in a hurry to leave the position and GSK is also not in a rush to throw him out because they are more interested in an orderly fashion of handling the situation. Deutsche Bank analyst Richard Parkes, stated that the decision will give Witty a chance to exit when things have calmed down because the company is expected to restore double digit growth in 2016.

David Epstein, the chief of Novartis has been mentioned as a potential successor to Witty. The poor performance of Advair is one of the main reason why there has been a lot of demand for Witty’s exit. The drug plummeted due to a lot of competition from biosimilars. The firm is also planning to make a comeback with CAR-T based oncology treatment. The company announced that it signed a deal a deal with MiltenyiBiotec for R&D cell and gene therapy in the initiative which will be led by Witty.

The company has however not revealed the financial terms of the deal but the two partners stated that the deal will combine GSK’s experience in cell and gene therapy with the cell processing platform presented by MiltenyiBiotec. GSK claims that the deal will be vital towards optimizing the manufacturing process involved in complex therapy. More automation will also help to push industrialization for gene and cell therapy.

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The CEO garnered a total of $18 million in 2015 but even though it is an impressive paycheck, there was a 23% decline compared to his salary of $$23.3 million in the previous year. The drop in his salary was attributed to lower stock earnings. The company claims that Mr. Read’s basic salary improved to $1.9 million in 2015 compared to$1.8 million in the previous year. His annual bonus also received a boost from $3 million in 2014 to $4.3 million in 2015.

Read’s stock awards had a big decline because he was offered $2.7 million from stock returns in 2015 compared to the $6.4 million that he received in the previous year. Despite the drop in his annual salary, it was a successful year for the CEO because he spearheaded some major achievements in 2015. Among them was progress in the meds pipeline and synergies from the acquisition of Hospira, Inc. (NYSE:HSP). The highest achievement for the year was a tax inversion deal worth $155 billion that the company struck with Allergan PLC.

The Allergan deal will result in the formation of the largest pharmaceutical company in the world and it will provide an opportunity for Pfizer to accrue some tax benefits from Allergan’s tax-friendly market. Pfizer also managed intellectual property protection issues in China and Europe. The company also registered significant growth in sales with Read at the helm of the firm. Pfizer garnered $14.05 billion in revenue in the fourth quarter of 2015.

The company anticipates $49 billion to $51 billion in revenues in 2016 which is slightly shy of the predictions by Street Ratings. There has also been word that Pfizer might be planning to form two firms out of its established and innovative products. However, the company has been silent about the matter perhaps because it has a lot to handle with the Allergan deal.

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The hefty compensations obviously means that last year was a very good year for Walbert and the whole company in general. The Hirizon CEO package is by far the highest pay that has been reported in the industry and no other pharmaceutical executive has received a paycheck that high.

Walbert’s total compensation was $93.4 million and it was ten times higher than the compensation for 2014. Performance data also indicates that the compensation for 2015 was 49 times higher than what was offered in 2013. The payment package was a combination of restricted shares whose value was $43.5 million and stock options valued at $47.4 million. The remaining amount includes a basic salary of $859,375 and a bonus $1.53 million. He also received another bonus worth $67,650 that was awarded to him by the board of directors. His allowances including the legal fee reimbursement, financial planning, pension contributions and travel expenses amounted to $62,537.

At the top of the list of highest paid heavy weights in the industry in 2014 was Len Schleifer, the CEO of Regeneron Pharmaceuticals Inc (NASDAQ:REGN) who received $41.97 million. Walbert’s paycheck doubles and adds onto Schleifer’s payment for FY14. The hefty compensation is an indicator that the company has been growing exponentially especially in in the stock performance. Horizon Pharma is relatively smaller than other industry giants such as Gilead Sciences, Inc. (NASDAQ:GILD) and Allergan whose CEO are paid a notably smaller amount.

It is also important to note that the firm has not released any blockbuster drug lately. However, the company’s total sales for 2015 amounted to $757 million. Its top selling drug is an anti-inflammatory drug called Duexis. Horizon’s sales were also significantly lower than what the competition registered but the company’s performance in the stock market has been relatively good and attractive. The success is attributable to the specialty pharmacy program designed to control payer pressure on medications.

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The fund is now part and parcel of Valeant’s board following the appointment of its vice chairman Steve Fraidwhom whom Ackman has assured the investors will play a fundamental role in protecting and maximizing the value of the company’s investment.

Valeant expects to collect between $11.0 billion to $11.2 billion in revenue which is way below the forecast of $12.5 to $12.7 billion made in December. On the other hand, the EPS had a prediction of $13.25 to $13.75, but it will now come in between $9.50 and $10.50.

Well, the investors will hear none of the reasons given for the changes bearing in mind that the tumbling of sales has affected several business. Other factors that have contributed to the company’s underperformance in the first-quarter guidance down to $2.3 to $2.4 billion in revenue include transition management issues as well as organizational distractions.

Ackman has since outlined the need to restore shareholder’s confidence in the governance of the company despite the many channel-stuffing allegations that forced the company to zero out nearly all of its planned price increases.

Nevertheless, it is expected that the newly returned J. Michael Pearson into the CEO’s chair will correct the course. Speaking to investors on a conference call, Pearson who was on medical leave of absence confirmed that the company has already taken the necessary steps that will enable the restructuring of the underperforming businesses.

Pearson is also hopeful that the exploration of divestitures of non-core assets will also heighten the drugmaker’s liquidity. With all that said, there is a promise by Valeant to win back the shareholder’s trust and confidence in the management.

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Using a sample of about 2,100 patients who are within their early-stages or have mild Alzheimer’s Lilly is attempting to test the twice failed solanezumab. In its first trial, which is now dubbed EXPEDITION3 cognition and physical functions were measured as co-primary endpoints. However, the current design is only concentrating on cognition as its main goal and whose function has been downgraded to a secondary endpoint.

According to Lily, the scientific evidence is expected to support the fact that cognitive decline goes before and predicts functional decline in Alzheimer’s disease and more so during the early stages.

Well, this realization will not change or affect Lilly’s operations in handling the global trial. The company says that the investigations will remain intact and hang onto the study data until the trial comes to an end in the fourth quarter of this year.

Apparently, it is the third time that Lilly is carrying out EXPEDITION3 whose efforts are all about proving that solanezumab which is an antibody therapy can give the Alzheimer’s disease a new course and definitely for the better. The therapy from solanezumab targets to slow down the memory-destroying advance of Alzheimer’s.

Back in 2012 and in a pair of Phase III trials, Lilly’s antibody was able to reduce amyloid buildups which are proteins in the brain. However, the treatment failed to outdo placebo at the improvement of cognition and function. It is at this point that Lilly realized that solanezumab had a significant cognitive effect on subjects with mild forms of the disease. All this led to the designing and implementation of EXPEDITION3 whose focus is now on those patients who want to win the approval of the usage.

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According to the Petah Tikva-based pharma, the wrapping up of acquisition may not happen until June, which is way too far than the projected end-of-March timeline. It is essential that FTC clears the companies and as such, it is waiting for a response from the Food and Drug Administration before embracing any decisions, and this will probably take some time.

Well, while arguing out the likely reason for the slowdown, Bernstein analyst Ronny Gal says that the Agency probably wants Teva to present certain and extensive divestitures- the ones the company will negotiate around with ease. Gal figures out that the impact of divestitures will be more fruitful that previously thought.

The company is planning to sell off a many of Allergan’s current generics business in the U.K. and Ireland. And just last week, it received an endorsement from the European Union to give up several assets across the pond. Teva will also discard a lot of its businesses. In the meantime, it will hang on to the Dublin drugmaker but still abandon molecules in 24 other countries on the continent.

The unfolding of events is likely to cause worry among the investors. However, Gal was quick to give an assurance that the selloffs will not in any way risk any current or future transactions. Gall further clarified all parties are committed and optimistic to concluding the deal in a positive way.

Gal has, however, outline that Pfizer may not clinch the news considering the close of its controversial $160 billion Allergan deal. Well, the deal I still pending as Allergan strive to finish up with Teva. Nevertheless, the Allergan deal will lead to the shifting of its tax base to Ireland.

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Phase III Clinical Trial

The results indicated that sarilumab was superior to adalimumab, which is branded by AbbVie, Inc. (NYSE:ABBV) as Humira, in terms of enhancing the signs and symptoms experienced by patients after 24 weeks.

Furthermore, the trial also met secondary endpoints such is the improvement in RA symptoms and physical function.

369 RA patients, whose systems are not able to respond to methotrexate, were enrolled in the clinical trial. They were randomly dosed with either 200 mg of sarilumab, an anti interleukin-6 receptor monoclonal antibody, or 40 mg of adalimumab every two weeks.

According to findings, this is the first time that an IL-6 receptor antibody has showed significant dominance over adalimumab monotherapy in treating patients with RA.

The pharmaceutical giant has initiated seven sarilumab studies in patients with different severity levels of RA, with this recent feat being the fourth to be completed. The remaining three are still being carried out.

Regeneron will file for regulation with the European Union (EU) regulators by the third quarter of the year. Moreover, the drug is also expected to receive an approval from the Food and Drug Administration (FDA) on October 30.

Regeneron Pharmaceuticals’ Tie Up with Sanofi

The positive results mark an important milestone for the collaborative efforts of Regeneron Pharmaceuticals and Sanofi to enter the market spearheaded by leading rivals such as AbbVie and Amgen, Inc. (NADAQ:AMGN).

Humira, for example, is AbbVie’s top-seller in 2015. The blockbuster drug accounted for about 60% of the company’s revenue for the year.

Simon Cooper, a Sanofi Immunology and Inflammation Department Global Project Head, said that even if the market is dominated by a variety of existing drugs, new and better alternatives are still necessary to further address the needs of those suffering from RA. Cooper believes that once approved, sarilumab will serve as an efficient alternative for those who cannot tolerate methotrexate.

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In Febraury, Fidelity Investments injected $400 million to the startup, bringing the latter’s valuation to $2.70 billion.

Expensive Contracts

Mario Schlosser, Oscar Health Insurance CEO, justified the hefty losses by saying that they were largely driven by costly health network contracts. Being new in the industry, the three-year-old company was unable to negiotate well to minimize the costs. In 2015, the insurer spent more than 75% of its premiums on hospital costs alone. This is significantly higher than the 63% spent by the biggest American health insurance company, UnitedHealthcare, for the same year.

The company hopes to recover from the recent downturn as the contracts are about to expire. Oscar Health Insurance seeks to obtain a more powerful negotiating stance this time, enabling it to reduce the hospital costs.

Oscar Health Insurance served nearly 53,000 members in NY. They acquired their respective insurance on the state-based exchange instead of opting for the healthcare benefits offered by Medicare and Medicaid.

Health Insurers vs. Obamacare

Many American health insurers have long been suffering since the 2010 Patient Protection and Affordable Care Act (ACA), also known as the Obamacare, was enacted.

Last year, Health Republic, the biggest Consumer Oriented and Operated Plan (CO-OP) in NY, was shut down by federal authorities after losing $130 million during its first 18 months. More than 200,000 residents in the state lost their insurance due to the foreclosure.

NY-based health insurance companies are not the only ones suffering from the current administration. Nearly half of the 23 CO-OPs established under the 2010 healthcare legislation located in various states such as Oregon, Nevada, Nebraska, Louisiana, Kentucky, and Iowa has also failed at large.

Dave Wichmann, UnitedHealth Group, Inc. (NYSE:UNH) President and CEO, believe that health insurers throughout the country are greatly challenged by expenses way costlier than projected due to public exchanges.

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MSF seeks to help emerging countries and humanitarian groups to gain access to more cheap vaccine alternatives, which the organization believes can only be produced without the presence of big pharmaceutical names such as Pfizer in the scene.

MSF vs. Pfizer

The filing came in after years of trying to convince the pharmaceutical giant to cut the price of the brand Prevenar in developing countries, making it more accessible to those who cannot avail of it.

MSF argued that about a million children aged five years old and below suffer and die due to pneumonia every year simply because there are no cheap vaccines available in poor countries.

However, Pfizer said that it has not yet received any notice of the pre-grant opposition. The company also claimed that it is dedicated to providing a reasonable program in India.

Vaccine PCV13

Presently, only Pfizer and GlaxoSmithKline plc (ADR) (NYSE:GSK) manufactures PCV13. Since the supply is tight, Pfizer has seemingly taken advantage of the situation by pricing Prevenar extremely high. The same goes for GSK’s Synflorix, which the company claims to be one of its “most complex” vaccines ever. Pfizer’s Prevnar sales in 2015 were seen at $6 billion while GSK made $548 million during the same year from Synflorix.

The companies have reasoned out that the pricing is high because it takes over two years just to manufacture a batch of the vaccine, which includes having to go through about 500 quality control inspections, and several production facilities.

According to MSF, the drug now costs 68 times greater than how much it would have cost in 2001. In line with this constant battle against the leading drug maker, MSF stated that there is a producer in India that can develop PCV13 and sell it for as low as $6 per kid, which is almost half the lowest price in the market today. This is inclusive of three doses. However, this depends on whether a patent will be secured or not.

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GSK’s Decision

Following a decision in January to halt the development of FP-1039 in squamous non-small cell lung cancer (sqNSCLC), GSK has given Five Prime Therapeutics on March 9 a 180-day notice to terminate the agreement.

Encouraged by the progress of the study, however, Five Prime Therapeutics will continue to work with GSK to fulfill the enrolment of patients in the Phase Ib of the trial against mesothelioma. According to the California-based company, GSK has presented the mesothelioma data at the ASCO 2016 annual meeting.

The US, Canada, and European rights to the FP-1039 were acquired by GSK in 2012 in a $3 billion deal to purchase Human Genome Sciences (NASDAQ:HGSI).

GSK pulled off from the trial due to the rise of Bristol-Myers Squibb Co. (NYSE:BMY) and Merck & Co., Inc. (NYSE:MRK) in developing immuno-oncology therapies. However, GSK and Five prime Therapeutics continue their partnership on research and development (R&D) efforts involving respiratory meds. The former has paid the latter 600,000 in target reservation fees to support the collaborative initiative on respiratory disease.

Five Prime Therapeutics’ Collaborations

Moreover, Five Prime Therapeutics is still in partnership with Bristol-Myers Squibb under a $1.74-billion global license concerning an immunology program, the colony stimulating factor 1 receptor antibody program that the latter acquired from Five Prime Therapeutics. The program includes the development of FPA008 therapy, which inhibits CSF1R and has shown a potential to block the activation of macrophages and monocytes.

Lewis Williams, Five Prime Therapeutics President and CEO, also claimed that the company has seen encouraging preliminary data from FPA144, the experimental gastric cancer drug. FPA144 is an anti-FGF receptor 2b (FGFR2b) monoclonal antibody developed to reinforce NK cells into the tumor.

Williams boasted that Five Prime Therapeutics has seen impressive progress in its internal immuno-oncology research initiatives aside from the success it has seen in its clinical programs.

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The European Patent Office (EPO) has revoked European Patent EP2137537, a method of use patent concerning Tecfidera, last week. If left unresolved, the move will take a big hit on Biogen’s balance sheets because sales of Tecfidera account for a third of its overall revenue in 2015.

Biogen expressed that it will immediately file an appeal as soon as the written decision of revocation from the EPO reaches its office. An appeal can hold up and suspend the revocation for about four years.

Biogen Director of Global Public Affairs Lindsey Smith clarified that the decision made by the EPO will not affect Biogen’s patents in the US and other parts of the world.

About Tecfidera

Launched in April, 2013 in the US and in Europe, Tecfidera has accounted for $3.60 billion in Biogen’s revenue last year. Aside from the patent challenge in Europe, the drug has also been challenged in the US by Forward Pharma. However, the United States Patent and Trademark Office (USPTO) has not yet arrived on a decision regarding the patent opposition.

Since it was unveiled officially in the markets, Tecfidera has quickly surpassed rival meds such as the Gilenya of Novartis AG (ADR) (NYSE:NVS) and the Aubagio of Sanofi SA (ADR) (NYSE:SNY) in terms of sales.

However, the drug took a quick hit in 2014 when a Tecfidera patient with a rare brain infection, commonly known as progressive multifocal leukoencephalopathy (PML), died. The company recouped in 2015 through various cost-cutting efforts that included 800 layoffs. The recovery was successful as Biogen reported a revenue increase of 16% in the fourth quarter.

Biogen and Shire plc (ADR) (NASDAQ:SHPG)

There have been rumors over the past few days that indicate a possible merger between Biogen and Shire to create a powerhouse pharmaceutical company. The latter is currently working on a tie-up with Baxalta, Inc. (NYSE:BXLT), which is presently working on a treatment for hemophilia, cancer, and hematology. Meanwhile, Biogen already has two drugs for hemophilia in the market.

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Aside from Papa, the company also rewarded Judy Brown, Perrigo Chief Financial Officer (CFO), and Todd Kingma, Perrigo General Counsel, with restricted stock worth $375K each during the same month. Perrigo is currently working on the cost-cutting efforts that were meant to elude the hostile takeover attempt of Mylan.

It was in October when Perrigo decided to lay off 800 employees, launch a buyback plan worth $2 billion of shares, and sell off its US business of minerals, vitamins, and other supplements.

Mylan’s Takeover Attempt

In April, Mylan revealed its proposal to purchase Perrigo particularly because of its over-the-counter (OTC) drugs. Since then, Papa and Robert Coury, Mylan Executive Chairman, have been involved in a war of words.

Papa kept arguing that the $26-million offer was not good enough for Perrigo since the pharmaceutical company has its own and far better prospects for the future.

The board unanimously rejected the offer. Eventually, 40% of Perrigo investors favored Mylan’s bid. However, the vote was not enough.

The failed attempt to acquire Perrigo did not stop Mylan from fulfilling its mergers and acquisitions (M&A) ambitions. Shortly after, Mylan has successfully purchased Sweden-based Meda in a $7.20 billion deal after the latter refused to the former’s bid twice. Meda, which is known for its wide array of respiratory and dermatology offerings, has rejected Mylan’s previous offer of approximately $6.70 billion in April, 2014.

The acquisition will help Mylan focus more on OTC medications, the goal it wanted to achieve with Perrigo. Heather Bresch, Mylan CEO, believes that the Meda takeover will allow Mylan to bring diverse products throughout the world as the company continues to expand and diversify its presence especially in the OTC landscape.

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Meanwhile, seven months after in-licensing a possible therapy for bone metastases, ITM Isotopen Technologien München AG has generated about $22 million to conduct clinical trials as part of its efforts to develop its targeted radionuclide therapies.

Novartis’ Shift of Focus

The move, which finally clarifies Novartis’ interest when it purchased the rights from GSK for about $1 billion, will shift the focus on testing Arzerra as a medication for relapsing multiple sclerosis. The Phase III trial of Arzerra on relapsing multiple sclerosis patients will begin later this year.

According to Genmab, the stopping of the trial has nothing to do with the safety of the substance. Moreover, it elaborated that Arzerra will not be developed to treat Devic’s disease or neuromyelitis optica, a condition in which the optic nerve and spinal cord are simultaneously inflamed and demyelinated.

The Phase III trial of Arzerra for the treatment of pemphigus vulgaris began in 2014, during which the drug was considered as an alternative to the existing drugs that counteract with the skin disorder.

ITM Clinical Trial Funding

The funding for carrying out ITM’s clinical trials came from Medtech Focused Family Office. According to Steffen Schuster, ITM CEO, the budget injection will help the company to set the bar anew around the world in precision oncology. Overall, the investment will drive global growth and expansion for ITM.

ITM is currently focused on developing treatments for bone metastases, prostate cancer, skin cancer, and neuroendocrine cancer.

Aside from the in-licensing of DOTA-Zoledronate, ITM has also filed the radiopharmaceutical precursor EndolucinBeta for approval in Europe last year. The brand is intended for the purposes of labelling carrier molecules for targeted radionuclide therapy. This provides a more specific cancer-hitting method with high toxic levels of radiation.

However, further details regarding the company’s programs have not yet been disclosed.

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According to the recent filing, Gonzalez has definitely attained his goals for the year as he led the company to greater heights with improved investor credibility and confidence.

Justifying the $20.81M Compensation

The compensation package of the 62-year-old executive is composed of a $1.59 billion base salary, nearly $3 million million incentive pay, $3.26 million options, and $9.75 million stock awards. It also included $2.45 million pension value growth and $791,000 in other compensation that included nearly $500,000 package for using AbbVie’s corporate aircraft.

The compensation committee of the pharmaceutical giant argued on Wednesday that this huge compensation can be justified by AbbVie’s “exceptional year”. AbbVie’s blockbuster anti-inflammatory drug, for example, had global sales amounting to $14 billion. Gonzalez can also be accounted for the buyout of Pharmacyclics, Inc. (NASDAQ:PCYC) in a deal worth $21 billion as he got his hands on Imbruvica, an upcoming blood cancer drug. Furthermore, the hep C cocktail Viekira Pak received approval from the Food and Drug Administration (FDA) in 2014. It was also approved in Japan in 2015.

His compensation, however, is relatively down from the $22 million Gonzalez received in 2014. It was understandable because 2014 had a highly different situation. He had a $5 million pension value growth, which is more than twice in 2015. His incentive pay in 2014 was also half a million greater than his incentive pay last year.

On the other hand, stock and option awards jumped from 2014 to 2015 with $1.50 million and $500,000 growths respectively. Also, Gonzalez had used the company’s aircraft unit more often in 2014.

2016

This 2016, Gonzalez is bound for a few changes. The board plans to cut his annual incentive pay target to 150% of his base pay from the original 200%. Along with this, the board also hopes to cut the value of his long-term incentive pay to $11.70 million.

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The whopping increase in advertising spending can highly be attributed to pricier advertisements.

Pricier Ads

For example, the most-anticipated football playoff season in January meant that drugmakers had to pay a huge premium. In February, the 50^th Super Bowl also had a huge impact on these advertisement spending. Three out of the top 10 companies in terms of advertising spending during that month roughly splurged $5 million per 30 seconds.

AstraZeneca plc (ADR) (NYSE:AZN), which was ranked as the second top spender in February, purchased a 60-second time slot. This means that over 60% of its estimated $16 million spending on TV advertisements was solely meant for its Super Bowl ad.

However, no pharmaceutical companies can take the place of the Humira of AbbVie, Inc. (NYSE:ABBV), being the top spender during both months. The company aired seven TV advertisements across three various indications: psoriasis, Crohn’s disease, and arthritis. This can be its final hurrah as it goes off patent in the US later this year.

Humira Global Sales

While the drug is enjoying robust sales today, some analysts believe that Humira sales are bound for a huge hit two years from now. During the fourth quarter of 2015, revenue surged 10.50% year-over-year at $3.72 billion globally. $2.33 billion of the revenue can be attributed to US sales. For the full year, Humira brought in a total of $14 billion, with more than half of it coming from the US. Richard Gonzalez, AbbVie CEO, reiterated that the company is not expecting any further revenue decline for the drug in the US.

February Top 10

The top 10 TV ad spenders last month included the Humira of AbbVie, the OIC of AstraZeneca, the Xifaxan of Valeant Pharmaceuticals International, Inc. (NYSE:VRX), the Eliquis of Pfizer, Inc. (NYSE:PFE) and Bristol-Myers Squibb Co. (NYSE:BMY), the Tamiflu of Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY), the Jublia of Valeant Pharmaceuticals, the Farxiga of AstraZeneca, the Breo of GlaxoSmithKline plc (ADR) (NYSE:GSK), the Lyrica of Pfizer, and the Cialis of Eli Lilly and Co. (NYSE:LLY).

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On the other hand, Anders Lonner stepped down from the board to focus on other priorities. Valeant Pharmaceuticals is now composed of a 14-man board.

The company hopes to make use of the long-time experience of its newcomers as it navigates the tumult over the past few months, which delayed the release of Valeant Pharmaceuticals’ earnings report and restatement.

Getting to Know the New Directors

Eshelman has been in the pharmaceutical industry for quite a long period of time. He has served as the CEO and Executive Chairman of Pharmaceutical Product Development, Inc. (NASDAQ:PPDI) and the Founding Chairman of Furiex Pharmaceuticals, Inc. (NASDAQ:FURX), which is now part of Allergan, Inc.

Fraidin, on the other hand, is a leading mergers and acquisitions (M&A) lawyer. He is currently the Vice Chairman of Pershing Square, hedge fund of activist investor and Valeant Pharmaceuticals enthusiast Bill Ackman.

Meanwhile, Ross has served as the President of UNC for five years. He is well-known for having steered UNC through a cheating scandal. He was specifically hired by Valeant Pharmaceuticals for his expertise in managing crisis.

Reasons

Valeant Pharmaceuticals Chairman Robert Ingram noted that the three were carefully selected to strengthen the company’s core. With Eshelman’s pharmaceutical experience, Fraidin’s corporate governance edge, and Ross’ extensive public policy prowess, Ingram elaborated that their versatility will drive the company’s growth further.

Michael Pearson, Valeant Pharmaceuticals CEO, said that this also marks the company’s first of many efforts to build its senior team with additional resources.

Pearson returned to office late last month following a two-month leave of absence (LOA) due to health reasons. It was during that time when Pearson turned over to Ingram the position as the company’s Chairman. The latter held the said position during Pearson’s absence.

Now, Valeant Pharmaceuticals is working on its growth through price hikes and M&A. Pearson has vowed that the company is committed in these areas in the long term.

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Telesta Therapeutics has come up with the decision after carefully reviewing its staffing and expenditures. The layoffs will largely affect the company’s manufacturing operation in Montreal. Aside from the layoffs, Telesta Therapeutics is also cutting costs in other significant areas such as internal and consulting expenditures. The company ended 2015 with a total cash of $20.30 million.

FDA’s Rejection

Telesta Therapeutics is trying to recoup after the Food and Drug Administration (FDA) declined its application for the approval of its bladder cancer drug last month, MCNA. Accordingly, the drug did not qualify for and meet the regulatory requirements.

The FDA asked the pharmaceutical company to conduct another Phase III trial to prove that the drug is indeed efficient and safe.

Currently, however, Telesta Therapeutics is still requesting for a Type A meeting with the FDA, in hopes to seek clarity as to what needs to be done to get the coveted approval in both the US and Europe.

Counteracting Losses

According to Michael Berendt, Telesta Therapeutics CEO and Chief Scientist, the company is constantly working with the board of directors on reviewing the strategic options available to protect Telesta’s interests over the coming months. Berendt added that the directors understand that this needs to be done in a timely manner in order to prevent further losses in the company’s cash resources.

Since the rejection of MCNA, Telesta Therapeutics has been dropping hints that it may resort to selling itself. In early February, following the FDA’s decision, Berendt said that the volatility in the financial markets has provided new array of opportunities for “well-capitalized companies”.

Last year, Telesta Therapeutics sold its MCNA European rights to France-based pharmaceutical company Ipsen SA (EPA:IPN). Under the deal, the former received an upfront payment worth $10 million. If MCNA gets the approval, Telesta Therapeutics is looking to an additional $127 million from Ipsen.

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In accordance to the Indian legislation and the protocols of the World Health Organization (WHO), the government has had open doors for early generic competition when a particularly important drug is quite expensive for local use.

New Legislation

It December, however, Indian authorities declined to give up the right to approve compulsory licenses. Instead, the government is working on a legislative amendments regarding India’s intellectual property approach on medicines. Accordingly, the proposal will allow India to employ several patent researchers and lawyers to hasten the review process of patent applications.

The delay in processing patent applications has been made worse with the lack of support from the judiciary as it works on a pile of patent-infringement cases. As a result, generic drugmakers have been taking advantage of the prolonged delays by infringing the IP rights of world-renown pharmaceutical companies when applications are still lined up.

Compulsory Licenses Dilemmas

The problems about compulsory licenses rose in 2012. During that time, Bayer was forced to let India based Natco Pharma to release a copycat version of Nexavar, its branded cancer drug. Since then, a number of domestic pharmaceutical companies have flocked and filed for compulsory licenses. However, patent officials have not yet approved any other compulsory license requests.

Compulsory licensing has not been the only barrier for large pharmaceutical companies in India. Patent officials have also nullified IP protections on branded products from Bristol-Myers Squibb Co. (NYSE:BMY), Pfizer, Inc. (NYSE:PFE), and Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY). Moreover, patent officials have also declined to patent drugs such as the leukemia medicine of Novartis AG (ADR) (NYSE:NVS), Gleevec. The courts have been merciless on the appeals for these said cases.

However, decisions over the past months have indicated that the Indian government is slowing down from its fight against large drugmakers. In January, the patent board denied Bristol-Myers Squibb’s compulsory license request for its diabetes med, Onglyza.

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As explained in the offer to purchase, the tender offer is subject to various conditions. Moreover, withdrawal rights for the offer have expired on Monday at 5 p.m., New York City (NYC) time, and are without any extensions.

Total Commissions, Tender Offer Considerations

Those who have validly tendered and did not withdraw their tendered notes and/or debentures validly on or before the expiration date and time and whose tenders have been accepted for purchase are entitled to receive the “Total Commission” that includes an early participation amount of $50 or €50 or £50 for each $1,000, €1,000, and £1,000 respectively and as applicable.

On the other hand, those who shall tender their notes and/or debentures validly after the expiration date and time and whose tenders will be accepted for purchase are entitled to receive the “Tender Offer Consideration”. The “Tender Offer Consideration” is equivalent to the “Total Consideration” amount without the early participation amount. Holders in this tender offer are also eligible to receive a cash payment that represents the accrued interest from the recent interest payment date excluding the date itself.

Determination of Total Considerations and Reference Yields

The resulting “Total Consideration” and applicable “Reference Yield” for each series of tendered notes and debentures will be determined with respect to each US-dollar-denominated series at 10 a.m., Tuesday, NYC time, and each Sterling-or-Euro-denominated series at 3 p.m., Tuesday, London time.

If there are enough remaining funds to purchase some of the remaining notes and debentures at any acceptance priority level not more than the tender tap, AIG will accept payments on a prorated basis.

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After sitting out for most of 2015, Amgen is now ready to join in the bandwagon of biotech acquisitions again this year. Meline added that it shall not come as a surprise if Amgen looks for heftier deals, saying that the company is excited about “being out there”. However, this does not indicate that Amgen will jump at any large transactions that will come along the way. While it looks out for more and larger acquisitions, Amgen remains to be selective in the process. The California-based biotech company has turned down a number of potential mergers late last year because they simply were not perfect as of the moment.

Possible Acquisitions

Currently, Amgen has $30 billion in cash and equivalents. Meline explained that discipline is difficult to maintain especially when there is available money sitting in the bank. The company is among the many biotech giants with extensive cash reserves that eye on further mergers and acquisitions (M&A). For example, Gilead Sciences, Inc. (NASDAQ:GILD) and Biogen, Inc. (NASDAQ:BIIB) have expressed their intentions to go beyond their comfort zones for new drugs. The companies have emphasized that the decline in biopharma price tags offers them greater opportunities to lift exceptional assets on the cheap.

As it continues to compete in the market and work on its new products, Amgen is eyeing Gilead Sciences because its record-breaking hepatitis C blockbusters have left it with nothing but a treasure trove of cash. Biogen, on the other hand, is also a possible target due to its slow growth.

Amgen is currently focusing on neuroscience and cardiovascular. Cardiovascular efforts of the biotech include the PCSK9 med Repatha and heart failure drug Corlanor. Meanwhile, its neuroscience efforts still do not have approved drugs.

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The transaction, subject to customary closing conditions, is expected to be fulfilled this first quarter. However, the terms of the agreement have not yet been announced to the public.

Extended International Presence to Drive NuVasive’s Growth

Jason M. Hannon, NuVasive International Executive Vice President (EVP), noted that the acquisition will allow the company to have a potential “direct engagement” in a significant market. Hannon added that this will drive growth for the company as it extends its presence in the Latin America. Moreover, NuVasive seeks to obtain direct contact with medical practitioners in Brazil to promote better healthcare provisions with the use of new and modern facilities and technologies.

For Gregory Lucier, NuVasive CEO and Chairman, the acquisition of Mega Surgical will help NuVasive to counter the intense volatility in the market, which has pretty much been visible in the company’s previous earnings results. Consequently, the company expects a boosted performance for the full year 2016.

Mega Surgical, founded in 1996, was originally established to distribute implantable medical devices. The Rio-de-Janeiro-based company has been partners with NuVasive since 2008.

Latest Quarterly Results

NuVasive released its latest earnings report last month, with results for the fourth quarter and the full year of 2015.

The company’s revenue for the quarter increased 5.40% to $215.30 million. This represents a 6.80% surge on a constant currency basis. For the fiscal year, revenue advanced 6.40% to $811.10 million. On a constant currency basis, this shows an increase of 8.20%.

Aside from the earnings results, NuVasive also revealed last month that it has fully acquired Ellipse Technologies. According to Lucier, the acquisition is a key milestone in economically meeting the world’s clinical needs by exploring various research and development efforts and opportunities.

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Boehringer Ingelheim is also entitled to a number of milestones for the deal, the details of which weren’t discussed to the public. AbbVie, on the other hand, shares in the late-stage development while claiming all the marketing rights for the said substance.

AbbVie-Boehringer Deal

The anti-IL-23 BI 655066 development is currently in its phase III for psoriasis. It is also being observed for its effects and implications on Crohn’s disease.

Under the deal, AbbVie also gains the sole rights to the Phase I drug, the anti-CD-40 antibody BI 655064. Meanwhile, Boehringer Ingelheim will be reserving the co-promotion rights for asthma.

With the deal, AbbVie reiterates its interest in a market that has seen remarkable returns for Humira. The said drug’s patent protection in the US is expected to mature in 2018. However, AbbVie is firm that it can withstand the pressure of the strong competition in the generic market.

Growing Competition over Immunology Drugs

What the pharmaceutical company cannot hold off is how immunology rivals have emerged in the market. Novartis AG (ADR) (NYSE:NVS), for example, has received an approval from the US Food and Drug Administration (FDA) for Cosentyx. The drug immediately rose to prominence last year.

Moreover, Eli Lilly and Co. (NYSE:LLY) is also seeking for FDA’s approval for ixekizumab this year. Ixekizumab is now on its late-stage development.

On the other hand, Merck & Co., Inc. (NYSE:MRK) is working on its late-stage development of the IL-23-blocking MK-3222 or the tildrakizumab. Similarly, Johnson & Johnson (NYSE:JNJ) is also working on the late-stage development of its counterpart, the guselkumab.

Meanwhile, AstraZeneca plc (ADR) (NYSE:AZN) had also worked on its own IL-17 brodalumab. However, the company handed it out to Valeant Pharmaceuticals International, Inc. (NYSE:VRX) following the completion of a $445 million acquisition. Amgen, Inc. (NASDAQ:AMGN) bowed out from the study after the drug has been linked to suicidal thinking.

AbbVie is slated to compete in this growing market with its drug that recorded a 69% PASI 90 score.

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Pharma Giants Suffer from Significant Losses

Novartis AG (ADR) (NYSE:NVS) reported a decline in net income of 18% year-over-year due to the “exceptional charges” amounting to about $337 million in its Venezuela subsidiaries.

Sanofi SA (ADR) (NYSE:SNY), on the other hand, reported a foreign exchange loss worth €240 million in the country. Another €100 million loss is expected to hit the company. Peter Guenter, Sanofi Executive Vice President (EVP), dubbed this as “the Venezuela effect”.

Sanofi is generally suffering particularly because of its huge presence in the region since it acquired Genfar in 2012.

Meanwhile, Pfizer, Inc. (NYSE:PFE) saw a decline of $0.07 in its earnings per share (EPS) for the full year 2015. The decline is widely attributed to the problems in Venezuela. The drug maker is expecting an $800 million currency loss.

Digesting Venezuela’s Hit on Drug Makers

Basically, the pharmaceutical sector was paid with much less than the outstanding bills of Venezuela— similar to what happened in Greece due to overwhelming financial crisis. However, the case in Venezuela was relatively different.

Novartis, for example, was paid in Venezuela’s local currency. The cash was then trapped effectively by currency controls. The firms then negotiated to use those currencies to buy US-dollar-denominated bonds issued by PDVSA, Venezuela’s state oil company.

Under the deal, the exchange rate was considerably low due to recent devaluation activities. Furthermore, Novartis was only able to sell the US-dollar-denominated bonds from PDVSA for just about 0.37 on the US dollar. This marked for another $127 million loss.

Other pharmaceutical companies engaged in the similar deals. In Greece, the bills were also settled in bonds through a special bond issue that were denominated in euros. The pharmaceutical companies that suffered from the Greek financial meltdown also sold the bonds at huge discounts.

The pharmaceutical sector is currently still forced to take local currency for ongoing drug bills in Venezuela amid the poor exchange rate. As a result, pulling off those “earnings” will just lead to more losses.

However, despite the present crisis, Frank D’Amelio, Pfizer Chief Financial Officer (CFO), remains positive that Venezuela will eventually bounce back.

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ARC002, the phase II of AR101 or the study involving the treatment of peanut allergy of Aimmune Therapeutics, Inc. (NASDAQ:AIMT), has shown better tolerability and desensitization with low-dose maintenance.

All patients who have fulfilled the 12-week low-dose maintenance therapy of AR101 were desensitized to peanut protein levels beyond what is usually found in a peanut kernel of about 250 to 300 mg.

PALISADE, the third phase of AR101, is now underway. AR101 is originally designed to enroll about 500 patients, aging from four to 55 years old, who are allergic to peanuts at over 60 clinical sites in Canada, US, and nine European countries.

The company ended down by 1.01% on Friday, closing at $17.70.

Ardelyx, Inc. (NASDAQ:ARDX) on Tenapanor

Ardelyx, Inc. (NASDAQ:ARDX), on the other hand, is expected to deliver the results from the second phase 2b clinical trial for treating patients with hyperphosphatemia in end-stage renal disease using Tenapanor by late 2016.

Aside from hyperphosphatemia, the drug candidate is also being tested for treating Irritable Bowel Syndrome with Constipation (IBS-C). The results from two phase III clinical trials are to be released in 2017.

Ardelyx was down by 9.15% during the last trading session, closing at $9.14.

MediciNova, Inc. (NASDAQ:MNOV) on MN-166

The results of the phase II of MN-166 demonstrated that Ibudilast has significantly decreased the effects of oxycodone and the desire for heroin, tobacco, and cocaine. Moreover, it also helped improve the analgesic effects of oxycodone on patients.

MediciNova is currently working on developing the study further as it hopes to accurately evaluate the efficiency of Ibudilast in treating opioid dependence.

The company tumbled 0.67% on Friday, closing the session at $5.91.

Tonix Pharmaceuticals Holding Corporation (NASDAQ:TNXP) on TNX-102 SL

Tonix Pharmaceuticals Holding Corporation (NASDAQ:TNXP) anticipates the results from the phase II, which is also known as AtEase, of TNX-102 SL, a clinical trial designed to study and evaluate the treatment for post-traumatic stress disorder (PTSE), by the second quarter.

The company is working on the third phase of the study for fibromyalgia, which is called AFFIRM. Results from the said phase are expected by the third quarter.

Tonix Pharmaceuticals lost 2.23% on Friday, ending at $2.41.

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Simultaneously, the results of the said study are presented at the annual meeting of the American Academy of Asthma, Allergy, and Immunology (AAAAI) Congress in California.

Safety Study Design and Results

The safety study was designed to compare AdvairDiskus, a combination of salmeterol, inhaled corticosteroid (ICS), and LABA, fluticasone propionate (FP), to FP monotherapy. It was made to evaluate the safety of each drug when used to asthmatic patients. Accordingly, AdvairDiskus’ safety profile is comparable to FP. Simply speaking— the combination of LABA, salmeterol, and fluticasone in one inhaler does not have adverse effects.

The risk of complications resulting from severe asthma attacks was 21% lower in the fluticasone-salmeterol group than in the fluticasone group, with exacerbations occurring in 10% of the glucocorticosteroid group and 8% of the combination group. Patients, who were primarily located in the US, Australia, Germany, Bulgaria, Denmark, Italy, Canada, and Slovenia, had undergone the testing for 26 weeks.

The Food and Drug Administration mandated GSK’s AUSTRI as a post-marketing requirement. It is the first to report results among numerous large-scale safety studies.

Three other manufacturers of drugs containing LABA are performing similar studies to assess whether LABA can heighten the risk of an event in the composite endpoint of asthma-related cases.

VESTRI

Moreover, GSK is also working on a second LABA safety study known as the VESTRI. AUSTRI was made for asthma on adolescent and adult patients while VESTRI is designed for asthma on children ages four to 11 years old. Results for VESTRI are expected by the end of the first quarter.

Controversies

In 2012, the Department of Justice filed a number of criminal and civil allegations against GSK on grounds of the unlawful promotion of several drugs that have not yet been medically approved. To settle the charges, GSK had to pay $3 billion. The drug maker argues that there have not been any corporate promotional strategies for the use of Advair.

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The news of Mammen’s new role was not well received by many within the industry. In fact, the likes of physicians and scientists who more often than not face the challenge of developing new medicines for complicated diseases expressed their frustrations upon receiving the news.

However, those who seemed to know Mammen maybe as a result of having interacted with him gave different accounts of a person they knew well both as a medical school classmate and a professional colleague. Many outlined that he has traversed a life path that was not easy but he has maintained his equanimity, hope and a sense of purpose unlike what anyone would contemplate.

One of Mammen’s classmates in their medical school program described him as intellectual, engaged and consistently decent with a top notch irrepressible determination to make the world a better place than he found. Anyone listening to these confessions about Merck’s new executive may tend to think that the observers are unbiased. However, it is more of personal reflections offering honest accounts of a person.

Word has it that working with Mammen has its benefits because he is one person who makes everyone feel part of the organization. Those that have worked with him have outlined that it is someone who embraces trust on culture and strives to build a remarkable character of any society.

And in words, Mammen designates his professional and personal life journey in a philosophical and emotional podcast with VC, Janelle Anderso, which he emphasise that it worth listening. To say the least, these are the kind of people that the rapidly growing pharmaceutical industry requires meeting its goals and objectives.

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Importance of Health Records

Health records containing one’s medical history are as important as— and sometimes, even more sensitive than— text and email messages. The Office of Civil Rights’ primary duty is to ensure the safety and the privacy of these documents as mandated in the Health Insurance Portability and Accountability Act (HIPAA). Aside from that, it is also responsible for providing efficient transparency that is intended to help patients obtain a much-needed awareness.

However, the current format of HHS Office of Civil Rights’ wall of shame fulfills neither of the two main reasons for its establishment.

Failure to Protect Patients’ Privacy

There are many factors that cause privacy breaches from time to time. The HHS Office of Civil Rights reports all privacy breach incidents on their website but it does not state how the documents were compromised. Moreover, the website also does not indicate the organizations or groups responsible for the breaching activities. In such case, the public shaming does not really occur. This quite does not help in preventing these incidents from happening in the near future.

With this system, patients are not necessarily freed from the fear of having their personal medical databases compromised. In line with this, there is a need for HHS Office of Civil Rights to amend its website and publish further details about the database breaches. Furthermore, American patients prefer for it to disclose publicly the ruling for each case and the resulting penalties for all violators.

As a government entity established for the protection of people’s rights, the HHS Office of Civil Rights also need to lead the campaign against medical record breaches. Instead of keeping up with the culture of finger-pointing, the HHS shall begin its efforts to investigate thoroughly the roots of every case at hand in order to create a breach-free healthcare database system.

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The divestment was supposed to begin this quarter but with the decision-making process taking too long, it may be delayed until early 2017. The details regarding the delay are limited since deliberations are considered private matter. According to people familiar with it, the French pharmaceutical company is weighing on selling all of its generics businesses worldwide, asset swap, or joint venture. Sanofi is also considering retaining its assets.

Brandicourt’s Strategic Options

Brandicourt revealed his new strategic measures in November. The options were meant to help Sanofi cope with the poor sales performance. His plans included the possibility of selling or spinning off European generics and Merial Animal Health businesses and simultaneously cutting costs up to €1.50 billion. The income generated from the efforts will be used to invest in Research and Development. According to the pharmaceutical company during that time, market complexities are generally increasing in the European region.

Following the announcement of Brandicourt, Sanofi said that it is in talks to trade Merial Animal Health with additional €4.70 billion in cash for the consumer healthcare business of Boehringer Ingelheim GmbH. The deal amounts to approximately €22.80 billion.

Global Generics Unit

Sanofi’s generics unit, Zentiva, operates 50 markets around the world. The business is at its strongest in Romania, Turkey, and Czech Republic with main manufacturing plants located in eastern and central Europe. Zentiva produces the former best-seller blood-thinner Plavix and the hypertension drug Aprovel, two of Sanofi’s drugs that have lost patent protection.

The drugs under Zentiva generated about €1.9 billion last year. Sanofi acquired the generics unit for $2.60 billion in 2008.

Last month, Brandicourt said that there are various options for the European generics business of Sanofi but he refused to give further details. He, however, assured that a decision will be made within 12 months, giving the company ample time to come up with a strategy that shall satisfy the long-term goals of Sanofi.

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