Samsung biosim nod sets J&J’s Remicade up for tough fight

Samsung Bioepis won FDA approval late Friday for its Remicade substitute, Renflexis (infliximab-abda), becoming the the second biosimilar to threaten that brand in the U.S. Not an unexpected event, and the launch isn’t expected until October because of biosimilar rollout rules. But six months pass quickly in the pharma world, and analysts see the second biosim emboldening payers to press for bigger rebates and pushing the three contenders to get more aggressive about winning share—or protecting it, as the case may be. Add into the mix the fact that Merck & Co. has marketing rights and the rivalry looks even more interesting. Soon, Remicade will have companies experienced on both sides of the biosimilar-brand competition making a run at its U.S. sales.

Lilly’s cancer med abemaciclib hits survival mark, but can it stand up to Ibrance and Kisqali?

Eli Lilly’s chances of snagging an abemaciclib approval as wide as those of its rivals are looking even better. In a phase 3 trial of the drug in previously untreated patients with HR-positive, HER2-negative breast cancer, abemaciclib nailed its primary endpoint, demonstrating significant improvement in progression-free survival. The performance follows up on last month’s positive results from Lilly’s other key trial, a test in patients whose cancer had come back after a first round of treatment. With those two sets of positive data in hand, the Indianapolis drugmaker is “assured of a product label with the same breadth” as that of Pfizer’s Ibrance and Novartis’ Kisqali, Bernstein analyst Tim Anderson predicted in a Monday note to clients. But that may not be enough to ensure abemaciclib’s success.

BioMarin sees ‘high end’ pricing on Brineura ahead of FDA decision

Children with a rare, devastating brain disease may soon have their first treatment option in BioMarin’s Brineura, up for an FDA decision later this week. And it’s likely to instantly join the ranks of the world’s most expensive meds if approved. Experts from the European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday endorsed the drug to treat Neuronal Ceroid Lipofuscinosis Type 2 disease, a form of Batten disease. The EMA usually green-lights drugs that have CHMP recommendations, but it isn’t required to do so. In the U.S., Brineura is set for a decision date the coming Friday. Execs at BioMarin said the company is in label discussions with the U.S. agency.

Biogen’s Spinraza scores later-onset SMA data for stepped-up push with payers

Hoping to win over careful payers, Biogen has new data to support its superpricey spinal muscular atrophy (SMA) drug Spinraza. In new phase 3 data from a study in children with later-onset SMA, patients on Spinraza “demonstrated a highly statistically significant and clinically meaningful improvement in motor function” over their counterparts who received a sham treatment, the Cambridge, Massachusetts-based biotech said in a Monday release. Biogen won approval for the med back in December and sparked criticism by pricing the groundbreaking injection at $750,000 for the first year, a figure that falls to $375,000 for subsequent years. In an earlier study of infantile-onset (type 1) patients, a higher percentage of children on Spinraza survived compared with untreated patients. Data from the newly finished study, Cherish, weren’t available at the time, but the FDA nonetheless approved the med for treatment of all SMA types.

Klick Labs creates empathy-boosting Parkinson’s simulator

Klick’s digital innovation unit Klick Labs created a device to transmit tremors from a Parkinson’s patient to someone who doesn’t suffer from the disease, to dramatically illustrate its effects. That’s empathy-creation in action, and the basis for a planned clinical study about the ways empathy can improve patients’ health. For pharmas, it’s a potential tool for sales-rep training. And the device can show differences between patients who are treated and those who aren’t, Klick says, opening up the potential for other applications. The programmable SymPulse device connects a Parkinson’s patient to a second person. A sensor on the patient digitizes and transmits tremors or muscle contractions, using electrical muscle stimulation, to a device worn by the non-patient. The result? The receiver can feel the exact same things the patient does. Klick refers to it as “tele-empathy.”


Malaysia calls for phase 4 Dengvaxia study before considering full approval

Already struggling to meet initial expectations, Sanofi Pasteur’s dengue vaccine Dengvaxia will have to undergo phase 4 testing in Malaysia before the endemic country agrees to sign off on a full approval. Malaysia’s National Pharmaceutical Regulatory Agency’s Drug Control Authority, which conditionally approved the vaccine, said in a notice that if the study fails to verify the clinical benefit, DCA may withdraw Dengvaxia’s registration. The French vaccine maker will conduct the two-year trial jointly with the country’s Ministry of Health, aiming to further assess the vaccine’s effectiveness and safety. Before the readout, the vaccine will only be available to eligible trial volunteers 9 to 45 years old. It won’t be covered by Malaysia’s National Immunisation Programme, meaning that participants will need to pay to get vaccinated.

Bristol-Myers’ Opdivo racks up latest NICE rejection, this time in head and neck cancer

Bristol-Myers Squibb’s Opdivo hasn’t even won marketing approval for head and neck cancer in England and Wales yet, but their cost watchdog is already shutting it out. The National Institute for Health and Care Excellence on Tuesday introduced the latest in a series of setbacks for the BMS immuno-oncology hotshot: draft guidance that doesn’t recommend it as a head and neck cancer therapy. The med’s costs—£439 per 40-mg vial and £1,097 per 100-mg vial, less a confidential discount agreed to with Bristol-Myers—“were considered to be very high in relation to its benefit to be recommended for routine NHS use at present,” Carole Longson, director of NICE’s health technology evaluation center.

FDA issues another Mylan plant in India a warning letter

Less than two years after being given a warning letter by the FDA for problems at three plants it got in its buyout of a sterile injectables specialist Agila Specialties, another Mylan plant in India has been issued a warning letter for ongoing data integrity issues. In the warning letter, issued last week and posted by the FDA today, the agency said investigators continued to find issues with batch testing results disappearing from computers when failed tests were involved. The observations were based on an inspection of the finished pharmaceutical plant in Maharashtra, India. It noted that even though the facility invalidated 101 of 139 initial out-of-specification (OOS) assay results, about 72%, employees never thoroughly investigated to find the root cause of the issues and didn’t include them in the results reported to the agency.

Mexican regulator undermines Teva’s Rimsa fraud claims with ‘all clear’ memorandum

Teva contends that Mexican generics buy Rimsa sold defective, illegal products and lied about it, duping not only itself as buyer, but regulators and the public as well. But a new memorandum from Mexico’s drug watchdog doesn’t help its case. According to a March 13 document seen by The Times of Israel, Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) found no “unexpected adverse effects” among Rimsa’s 147 products and has located authorization for all of them within its archives. Sixteen COFEPRIS checks on Rimsa dating back to 2009 also failed to turn up any issues that could pose health risks, and the body found documentation provided by Rimsa to be “truthful and correct.” The conclusions don’t exactly support Teva’s legal claims that Rimsa withheld discrepancies between manufacturing processes and descriptions in product registrations filed with regulators.

Mission bags Fox Foundation grant for Parkinson’s program

Mission Therapeutics and the University of Oxford have landed a grant to fund testing of USP30 inhibitors. The Michael J. Fox Foundation for Parkinson’s Research (MJFF) is putting up the money to enable Mission to test its USP30 inhibitors in stem cell-derived Parkinson’s disease models. MJFF is funding the research in an attempt to validate USP30 as a target for the treatment of Parkinson’s. By inhibiting USP30 in malfunctioning mitochondria, the scientists stand to show whether the therapeutic approach may improve the operation of the organelles and neuron health. And there is an expectation this will enable the identification of biomarkers of USP30 that will prove useful in subsequent clinical development.

Hemophilia A- Market Scenario

Hemophilia is the most common inherited bleeding disorder which leads to spontaneous bleeding as the blood does not clot properly. Hemophilia, characterized by the spontaneous bleeding and swollen joints due to bleeding into the joints, is of several different types- such as Hemophilia A, Hemophilia B, and Hemophilia C. Hemophilia A is the most common type, which occurs due to the deficiency or decrease of factor VIII- a factor that plays a major role in clotting blood. The severity of Hemophilia A depends on the presence of plasma levels of factor VIII.

According to the National Heart, Lung, and Blood Institute (NHLBI), Hemophilia A is observed among 8 out of 10 patients with Hemophilia. Hemophilia A (factor VIII deficiency) is four times as common as Hemophilia B (Factor IX deficiency).


There are around 20 drugs which are being marketed worldwide for the treatment, prophylaxis or management for Hemophilia A. Though Kogenate FS (developed by Bayer HealthCare) lost its patent, still, it is the top-selling drug of Hemophilia A contributing to the majority of the market size. The market is also dominated with several recombinant proteins developed by the major players such as Baxter, Bayer, and Pfizer. Among major players, Shire Plc is the most progressive company which has recently been acquired Baxalta in June 2016.

Advate is also leading the race for Hemophilia A.  Revenues of Advate have had a major impact on the market. Development of novel coagulating factors, technological advancement, and advancement in diagnosis techniques are stimulating the growth of the market.

Additionally, Baxalta (now Shire) is also facing tough competition from the Biogen IDEC with the launch of long-acting therapies such as Eloctate for Hemophilia A.  Bayer has recently received approval Recombinant Factor VIII, Kovaltry in 2016 which is expected to fuel the market growth for the forecasted period. Hemophilia A market is expected to increase due to upcoming Hemophilia therapies which shall be launched in 2019 (Turoctocog alfa pegol for Hemophilia A and LR769 for Hemophilia A and Hemophilia B) and 2021 (Emicizumab and Damoctocog alfa pegol for Hemophilia A).

Insight by:
Sukhvinder Singh
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business, facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutic indications. DelveInsight has a database of 3000+ high-quality analytical reports.

The Business Cocktail

Valeant’s asset-sale woes continue as Stada, Mundipharma lowball iNova bids

Embattled Valeant has promised its investors $8 billion in asset sales—but as the company’s latest deal struggles continue to demonstrate, getting there may not be so easy. The bids rolling in for Valeant’s Australian iNova subsidiary aren’t quite up to expectations, with a private equity consortium comprising The Carlyle Group and Pacific Equity Partners, as well as fellow drug makers Mundipharma and Stada, each launching offers of around $900 million. Now, the Review says, Valeant is weighing whether to hang onto iNova—which sells products ranging from weight-loss drug Duromine to asthma treatment Qvar—after the Goldman Sachs-run sales process. Late last year, Valeant also reportedly tried to sell its underperforming GI unit, Salix, to Japan’s Takeda, but talks on a $10 billion deal ultimately fell through over price.

Sanofi Pasteur coughs up $19.8M to settle claims it overbilled the VA

Sanofi Pasteur agreed to pay more than $19.8 million to settle allegations that it overcharged the Department of Veterans Affairs for its products. The French pharma’s vaccines unit voluntarily reported the “calculation and reporting error” with the VA in 2012, and has since “cooperated fully and negotiated in good faith with the government,” according to a statement from the company. Sanofi Pasteur based its first disclosure to the U.S. government on products sold to the VA from 2007 to 2011. A follow-up investigation by the VA’s Office of Inspector General found the overcharging error dated back to 2002, the DOJ said in a statement. Sanofi said that, for some products, the miscalculation led to a lower price to the VA. The company will not seek reimbursement for those undercharges, it said. Neither the DOJ nor Sanofi identified the products involved.

With key rollouts looming, Sanofi’s Genzyme chief Meeker hands over the helm

As Sanofi gears up its biggest launch of the year, the Genzyme chief tasked with overseeing that rollout is leaving the company. David Meeker, CEO of the U.S.-based Sanofi unit and EVP overall, will exit as of June, with Bill Sibold—Sanofi Genzyme’s head of multiple sclerosis, oncology and immunology—taking his place. Sibold’s ascendance comes as Sanofi Genzyme grows in importance for the France-based drug maker. Pegged as one of the company’s “growth platforms” from the days after ex-CEO Chris Viehbacher engineered the acquisition, Genzyme is shouldering an even bigger load now. It’s another in a series of executive changes at Sanofi as well, as CEO Olivier Brandicourt, who took the helm in February 2015, shuffles his team and the divisions they lead.

India’s Alkem says the FDA has approved upgrade plans for cited API plant

After a year of nothing but bad news about FDA citations of its plants, India’s Alkem Laboratories has announced something positive. The Indian drugmaker said that the FDA has issued an Establishment Inspection Report, signing off on Alkem’s plans to upgrade operations at its API plant in Ankaleshwar, India. The plant had been cited with a Form 483 with three observations during a visit by the FDA in December. The drugmaker has 14 manufacturing sites in India and the FDA has been doing a series of inspections after being alerted to problems by U.K. regulators who claimed the drugmaker had used fake data in clinical trials of an unspecified antibiotic and brain disorder drug. That alert came after the FDA had serious issues with Alkem shipping unapproved drugs to the U.S.

GSK recalling nearly 600,000 Ventolin inhalers in U.S.

With sales of its respiratory drugs doing well, GlaxoSmithKline has been spending hundreds of millions of dollars to expand manufacturing of several kinds of inhalers. But a glitch at one of its Ventolin inhaler plants has resulted in recalling nearly 600,000 units in the U.S. According to an FDA Enforcement Report, GSK recently began recalling 593,088 Ventolin inhalers after discovering that an elevated number of the units were out of specification for leak rate, the company reported. The units were manufactured at its plant in Zebulon, North Carolina. A GSK spokesperson pointed out this was not a consumer level recall, so patients can keep any Ventolin inhalers they have on hand. The voluntary recall is to the retail and wholesaler level so products are being removed from those channels.



Biogen triumphs in latest Tecfidera patent dispute

Biogen has prevailed in a patent squabble with Denmark’s Forward Pharma over multiple sclerosis med Tecfidera—but the decision may not actually help the Big Biotech steer clear of generic rivals. The Patent Trial and Appeal Board (PTAB) ruled Friday that Forward could not declare patent infringement by Biogen. The verdict kept Biogen’s Tecfidera IP intact and secured exclusivity through 2028. It’s an outcome that is worth about $5 of upside to Biogen’s stock. In January, Biogen hedged the outcome of the Forward challenge by agreeing to a $1.25 billion settlement with the Danish pharma. The deal would have allowed it to license Forward’s IP to shield Tecfidera had the PTAB ruling not gone its way. But now that its own IP shield can stay, Biogen will not need to use Forward’s IP, and it also will not owe a royalty contingent for that settlement worth 10% of U.S. sales.

Lilly, Pfizer, Ipsen back Sanofi and Regeneron in PCSK9 patent appeal, AbbVie doesn’t

Big Pharma is enthralled with the Amgen vs. Sanofi patent fight, as its outcome could affect their in-development meds. Amgen, which makes the cholesterol-fighting Repatha, is asserting an antibody patent that, if upheld, could give the California biotech the power to push Sanofi and Regeneron’s rival PCSK9 drug off the market. And it’s a type of patent that has the potential to allow Amgen—and other drugmakers in other fields—to stake out a claim to an entire class of therapies, or so Sanofi’s legal team said in a recent phone conference with reporters. And that’s why drugmakers have been weighing in with amicus curiae briefs at the U.S. Appeals Court for the Federal Circuit, which hears all patent appeals—Pfizer, Eli Lilly and Ipsen among them. The lone outlier, at least so far is AbbVie. AbbVie’s brief contends that antibodies are expensive to develop, and without strong patent protections that limit competition, wouldn’t be worth the expense. Patent protection may mean drugs cost more in the short run, but that’s the price of developing new and complex biologic treatments, the brief states.

Court nixes Acorda patents, teeing up Ampyra generics

Acorda Therapeutics’ IP protection on Ampyra may have held up against pharma patent challenger Kyle Bass at the U.S. Patent and Trademark Office, but it didn’t do the same in court. A U.S. District Court stamped out four of the company’s five patents on the med for multiple sclerosis patients, dubbing them invalid on the grounds of obviousness. It kept just one—a sustained-release patent set to expire in mid-2018—meaning generic competition in 2018 is “realistic,” Leerink Partners analyst Paul Matteis wrote in a note to clients. Ardsley, NY-based Acorda, unsurprisingly, plans to appeal the decision, but it’s not going to sit back and wait for an about-face in court. The company has developed contingency plans for early Ampyra generics, and it “will provide an update after finalizing the implementation timeline”.

Mylan EpiPen recall goes global but company says it has plenty of replacements

A recall of potentially malfunctioning EpiPens that Mylan first announced for Europe, Japan and Asia has now gone global, including the U.S., with the company retrieving tens of thousands more. Mylan, however, says it has plenty of replacements to avoid any interruptions in supply. The drugmaker announced the expanded recall of late Friday after the markets closed. According to the FDA, Mylan is voluntarily recalling the 0.3 mg and 0.15 mg strengths of EpiPen and EpiPen Jr. Auto-Injector because of a problem that may keep them from activating. The recall does not include any of its Mylan’s new authorized generic EpiPens. The first recall was for Japan, Australia and some markets in Europe. Now it has been expanded to the U.S. as well as additional markets in Europe, Asia and North and South America.


The Business Cocktail

Mylan closing Illinois plant, cutting 90 jobs as part of slim-down after Meda buyout

Mylan has been in the midst of cutting about 3,500 jobs to decrease costs and refocus after its $7 billion buyout last year of Meda Pharmaceuticals. About 90 of those cuts will come with the closure of a plant in Illinois.The drugmaker will shutter a small plant in Decatur, Illinois, that it picked up last year in buyout of Sweden’s Meda, a company that came with about 4,500 employees. A spokesperson said the Decatur plant, which makes a variety of products such as pain med Soma and multivitamin Geritol, will be phased out over several months and the final closure will be in 2018. Mylan has already closed the Meda U.S. headquarters in Somerset, New Jersey, eliminating 94 employees there.

Insys spending $24M on manufacturing expansion

Insys Therapeutics is scrambling to right itself after being knocked akilter by an indictment claiming its former CEO and a group of other ex-top execs bribed doctors to prescribe its Subsys painkiller. But the legal turmoil has not stopped the drugmaker from adding capacity to a Texas manufacturing site. Insys is completing a 30,000 square-foot expansion at its manufacturing site in Round Rock, Texas. The company is investing $24 million to outfit the operation and add an undefined number of jobs. In 2013, the Chandler, Arizona-based company received financial incentives from Round Rock for its $10.5 million expansion into a larger manufacturing facility in the Texas town.

Roche’s much-anticipated MS game-changer, Ocrevus, nabs its FDA green light

The new med Roche has been anticipating—and the multiple sclerosis market shake-up drugmakers have been dreading—is here. Regulators approved the Swiss drugmaker’s Ocrevus to treat two forms of the disease—relapsing remitting MS and the harder-to-treat primary progressive form—in adult patients. The thumbs-up follows a three-month delay, when the agency asked Roche for additional data on the Ocrevus manufacturing process. Now, the wait is over for Roche, which stands to win big with the blockbuster wannabe. It’s pricing the med at $65,000 per year, marking a 25% discount to Merck KGaA rival Rebif, a drug it topped in clinical trials, and a 20% discount, on average, to other MS therapies, Mizuho analyst Salim Syed wrote in a note to clients.

Greece’s corruption prosecutor quits, citing pressure over Novartis bribery probe

Novartis is embroiled in a soap opera in Greece, complete with bribery allegations and a suicide threat. Now the plot is thickening. The country’s chief corruption prosecutor, Eleni Raikou, has resigned—and she’s blaming the Swiss pharma giant’s legal issues for her decision. Raikou stepped down over the weekend, sending a letter to Greece’s Supreme Court claiming she was targeted by “unofficial power centres” over her investigation of Novartis, which started in early January. Her resignation followed a less-than-flattering article in a weekly newspaper, according to anonymous sources quoted by the wire service. In her resignation letter, she griped about a lack of “institutional protection”. Greek authorities raided Novartis’ offices in that country after one of the company’s local managers reportedly made a suicide threat on New Year’s Day at a hotel. The executive was one of the employees the authorities were interviewing, according to multiple media reports at the time.


Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib

Tesaro’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod on 27th March, months before its scheduled decision date. Apart from getting approval, Zejula also got a broader label than its head-to-head rival, Lynparza from AstraZeneca. It’s approved to treat all women with recurrent ovarian, fallopian tube or peritoneal cancer who’ve previously responded to platinum chemo, not just those who test positive for the BRCA genetic mutation. With 2022 sales expectations of $1.9 billion, Zejula is one of the top drug launches of 2017. And with some strong data showing its ability to hold off cancer progression for more than a year in some patients, it could be a quick challenger for market share when it launches, expected in late April.

XELJANZ® receives marketing authorisation in the EU for moderate to severe rheumatoid arthritis

Pfizer Inc. announced that the European Commission (EC) has approved XELJANZ® 5 mg twice daily (BID) oral tablets in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). XELJANZ can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. XELJANZ belongs to a new class of therapies called Janus kinase (JAK) inhibitors. The EC approval is based on a submission package that included results from the Phase 3 Oral Rheumatoid Arthritis triaLs (ORAL) global development program and real world data.

Innovus Pharma nabs European patent for Sensum+

Innovus Pharmaceuticals received a Notice of Intention to Grant from the European Patent Office for a patent titled “Sensitization composition and method of use” covering its Sensum + product for reduced penile sensitivity. The Notice of Intention to Grant from the EPO adds great value to the CPNP notification to market Sensum+® in Europe. Having a patented product has increased the ability of the company to enter into new commercial partnerships for Sensum+® in Europe. Sensum + is a non-medicated cream used by men to enhance sexual satisfaction.

Alexion brings on former Baxalta chief Hantson to fill vacant CEO spot

Alexion’s CEO search is over. The Connecticut biotech, which bade its skipper farewell late last year, is bringing former Baxalta chief Ludwig Hantson into the fold. Hantson will take the reins from David Brennan, who stepped in as interim CEO after David Hallal made his exit last December. Brennan will remain on Alexion’s board, which expects to appoint him chairman at the company’s mid-May annual meeting, Alexion said.


Novartis heart-failure med Entresto cuts A1c, insulin starts in diabetics

Novartis has been mining a pivotal study of Entresto, its heart-failure med, for more insights ever since it was first published in 2014. Now, a new analysis shows that Entresto beat an older med at reducing blood sugar levels in heart failure patients with diabetes. By breaking out and analyzing data on 3,778 diabetic patients who participated in the Paradigm-HF trial, researchers found that those in the Entresto arm saw a 0.26% drop in HbA1c, a commonly used measure of blood sugar levels, compared with 0.16% among those taking enalapril, an older heart failure remedy. And 29% fewer diabetics in the Entresto arm needed to start insulin therapy during the course of the study, compared with those in the enalapril arm.

Diabetes meds from AZ, J&J and Lilly sharply cut death rates in real-world analysis

A massive data analysis showed that SGLT2 diabetes drugs significantly cut heart failure hospitalizations and deaths, results that stand to have a “substantial impact” on prescribing habits, if AstraZeneca’s U.S. president sees his predictions come true. In a real-world study dubbed CVD-Real, researchers sifted records on more than 300,000 patients in six countries to find that SGLT2 meds cut heart failure hospitalization rates by 39% compared with other types of diabetes treatments. The drug class—which includes AZ’s own Farxiga as well as Johnson & Johnson’s Invokana and Eli Lilly and Boehringer Ingelheim’s Jardiance—also reduced deaths from any cause by 51%, according to the study, presented Sunday at the American College of Cardiology conference. The analysis echoes the results of a landmark Jardiance outcomes study, Empa-Reg Outcome, in which patients taking the SGLT2 drug saw a 35% reduction in risk for heart failure hospitalizations.

CAR-T drugs worth up to $649K in childhood leukemia

Health authorities in Britain ran cost-effectiveness numbers on pioneering CAR-T therapies that might be used to treat acute lymphoblastic leukemia in children, and payers may not want to hear the results. A National Institute for Health and Care Excellence mock technology appraisal analysis—highlighted in a Thursday note from analysts at Jefferies—found that a $649,000 price tag on the therapies would be justified for young patients with acute lymphoblastic leukemia (ALL). That doesn’t mean Novartis, Kite and other CAR-T drugmakers will charge that much if and when their treatments get approved in ALL, or that payers would shell out even close to that amount. The Jefferies analysts say the $649,000 figure is likely the “upper bound” on the treatment from Kite, which is working toward a filing in non-Hodgkin lymphoma first. The analysts didn’t discuss the other CAR-T companies in their note.

FDA warns of pancreatitis deaths from treatment with Allergan’s IBS-D med Viberzi

Allergan has been working hard to buoy IBS-D med Viberzi through a series of marketing efforts and tech partnerships. But now, a safety hurdle could get in the way. The FDA has warned that patients without a gallbladder shouldn’t use the med after an agency review found an increased risk for those patients of developing serious pancreatitis that could result in hospitalization or even death. In fact, hospitalizations and deaths from pancreatitis have already been reported in patients without gallbladders who were taking Allergan’s product, the FDA said. Regulators recommended patients in that pool “stop taking Viberzi right away.” It’s a setback for the Dublin drugmaker, which has been pushing hard to expand use of the med since winning a May 2015 approval on the same day as Valeant’s IBS-D contender, Xifaxan.


Pfizer faces first 2017 patent loss as Pristiq generics arrive

Pfizer faces a challenging year on the patent loss front, starting with the generics of its antidepressant Pristiq now hitting the market. Mylan today said it had launched its copycat of desvenlafaxine extended-release tablets, in 50 mg and 100 mg doses. India’s Lupin also has its version on the market and a slew of other generic makers, including Sandoz and Teva’s new Actavis unit, have approvals. Pristiq itself was a drug launched to protect Pfizer sales from the patent loss on a preceding antidepressant, Effexor. Pristiq was first developed by Wyeth before it merged into Pfizer in 2009 to create the drug giant it is today.

Surprised shareholders target Allergan over generics pricing probe

Allergan no longer owns Actavis, having unloaded the generics unit to Teva. That hasn’t kept the drugmaker from facing potential fallout from shareholders who say Allergan’s share price has been stung by questionable pricing practices when it did. Former employee Andrew Ormond launched a class action suit against the drugmaker, arguing its shares were “artificially inflated” between Feb. 25, 2014, and Nov. 2, 2016. Several Allergan press releases and filings from the company praised its own performance during that time, but the lawsuit claims that behind the scenes, things weren’t all that genial. Allergan “and several of its pharmaceutical industry peers colluded to fix generic drug prices in violation of federal antitrust laws,” according to the class action. That put the company “at risk of criminal prosecution and civil and criminal penalties,” factors that investors couldn’t assess, according to the suit.

Chinese drugmakers, PE firms pile into Stada deal action

The race to snatch up generics maker Stada is heating up ever since the Boston private equity outfit Advent International put up the first legally binding bid for the drugmaker, multiple players are reportedly preparing to jump into the fray. CVC Capital Partners, which held deal talks with Stada last year, is ready to come back for another try, and it’s considering joining hands with a Chinese drugmaker to do it. The private equity firm is in early-stage talks with Fosun Pharmaceuticals about a joint bid, which is looking to continue down the global expansion path after acquiring India’s Gland Pharma last year. CVC is also talking with Shanghai Pharmaceuticals Holding about teaming up.

Sun Pharma rallies 7% as USFDA lifts import alert on Mohali unit

Shares of Sun Pharmaceuticals shot up nearly 7 per cent in Tuesday’s trade after said that USFDA on Monday lifted the import alert imposed on the company’s Mohali manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. Following the report, the stock jumped 6.57 per cent to hit a high of Rs 728.45 on BSE. The company’s market capitalisation rose by over Rs 10,000 crore to Rs 1.74 lakh crore. The Mohali facility was inherited by Sun Pharma as part of its acquisition of Ranbaxy Laboratories in 2015. The US FDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy’s Consent Decree of Permanent Injunction.



NPPA slams pharma giants for overcharging

The price regulator in the pharmaceutical industry, National Pharmaceutical Price Authority (NPPA) has discovered that the leading Pharma companies are overcharging customers for abundantly prevalent drugs in the market. NPPA has alleged that the listed 634 drugs are being sold at prices higher than their ceiling price fixed by the Drug Price Control Order (DPCO). The list includes Pharma giants, Sun Pharmaceuticals, Lupin Pharma, Cipla, Cadila Healthcare and many more. The regulator, NPPA has sent notices to these companies to lower the prices of overcharged drugs to their normal prices as stated under the DPCO. The list of overcharged drugs includes commonly used medicines such as Gelusil, Soframycin and Ring-Guard.

Japan Joins Trump in Drug Price War Crimping Pharma Profits

President Donald Trump has pledged to reverse what he describes as “astronomical” drug prices in the U.S. Thousands of miles away, Japan, long a profit sanctuary for multinational pharmaceutical companies, is taking a similar tack. About $93 billion is spent annually on medications in Japan, and the government plays a key role on prices because it covers about 40 percent of the country’s health spending via its national insurance scheme. In December, officials announced plans to review drug prices more frequently: annually for all therapies and quarterly for the newest and most expensive ones that are used widely. Over recent months, the price of Opdivo was halved in the Asian country following a 32 percent cut in April for Gilead Sciences Inc.’s hepatitis cure Sovaldi. The industry fears that could just be the beginning. With the annual price review in place, the sector’s sales in Japan, the world’s third-largest drug market, are estimated to fall by 30 percent to about $62 billion through 2025.

PCI Pharma Services Announces Significant Expansion in Serialization Technology

Leading outsourcing services provider PCI Pharma Services (PCI) today announced a significant expansion of its market leading Serialization capability. PCI will increase Serialization capacity across its global supply network to support clients in advance of meeting both US DSCSA and EU FMD implementation dates. PCI has been actively serializing commercial products for the past five years, with products destined for North America and Europe, in addition to emerging market geographies such as South Korea, Turkey, Brazil, China and others. In total, PCI supports medicines destined to over 100 global countries. PCI’s announced expansion triples its global Serialization capacity in advance of upcoming DSCSA and FMD requirements.

Merck KGaA opens new Allergopharma plant in Germany

Allergopharma, the allergy meds unit of Merck KGaA, has opened a new biopharmaceutical production plant near Hamburg. The €42 million ($44.4 million), 6,000-square-meter (64,583-square-foot) facility was built at the current Allergopharma complex in Reinbek. It is part of a global expansion, Simon Sturge, CFO of Merck’s healthcare unit, said in a statement. When Allergopharma announced plans for the new facility in 2013, it said about 40 jobs would be added to the site to staff the new, two-story facility, where Allergopharma will make recombinant allergens to treat conditions like hay fever and allergic asthma. About 500 employees work at the site. The company has said this is Allergopharma’s largest investment to date and will help with its expansion into emerging countries like China as well as developed markets.

Mylan and Biocon finally win right to sell Herceptin biosimilar in India

Mylan and Biocon have approvals for their Herceptin biosimilar pending in the U.S. and Europe, but just today won a court ruling that said they may sell their version in India where it was first approved three years ago. The Delhi High Court ruled that the partners have the right to sell their versions of the blockbuster breast cancer drug in India and refer to it as a biosimilar of Herceptin. The two developed the biosimilar together but are each launching their own brands there, CANMAB by Biocon and Hertraz by Mylan. Roche has aggressively fought the introduction of the drug there since 2014, claiming that India’s drug regulator had approved the Mylan and Biocon drug before it had adopted guidelines for how biosimilars would be approved. The Swiss drugmaker claimed the two companies relied on Roche data, rather than their own, to develop their product and that there was no guarantee of biosimilarity and so shouldn’t be sold as one.