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VIDEOSeptember's BioPharma Catalyst Calendar
This month could be full of opportunities for biotech and pharmaceutical investors who know where to look.
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Early September
Vivus (VVUS) is expected to announce data from its two-year Sequel clinical trial. The 650-patient study included three treatment arms -- two that were taking doses of Vivus' obesity drug Qnexa and one that was a placebo. The patients were originally enrolled in Vivus Conquer study and then continued for an extra year. The biotech claims that the study will enhance the safety and efficacy data of the drug, but it doesn't include data on teratogenicity or cardiovascular risks.
September 7
Forest Laboratories (FRX) faces an FDA Advisory Committee for its antibiotic ceftaroline that's meant for the treatment of skin and soft-tissue infections. Oppenheimer analyst John Newman estimates the biotech’s shares could swing as much as $2 to $3 in either direction depending on the outcome of the panel. “We remain cautious heading into the panel and expect the FDA's briefing documents to shed light on potential efficacy and safety analysis. Given the limited safety data available, we remain cautiously positive and look ahead for further clarity provided by FDA briefing docs. We believe recently updated FDA guidance increases ceftaroline risk since endpoints suggested by FDA are different than those used in FRX's phase III program,” Oppenheimer wrote in a recent note.
September 12-15
Infectious-disease experts will be congregating in Boston for the International Conference of Antimicrobial Agents and Chemotherapy annual meeting. Investors of Cubist Pharmaceuticals (CBST) should be watching out for further data on CXA-101, a drug the company acquired last year. A glimpse of top-line results for the treatment of complicated urinary tract infections was released in June, but the company will be expanding on what looks like positive results. This is important to Cubist’s CXA-201 program, which is a combination of CXA-101 and another agent. The company has recently begun a mid-stage study for CXA-201.
September 15
Abbott Laboratories’ (ABT) obesity drug Meridia will be reviewed by an FDA Advisory Committee in regards to concerns about its safety -- particularly cardiovascular risks. This meeting comes just months after European regulators pulled the drug form the market. Abbott stands to lose $300 million in revenues if the drug gets yanked off the US market.
(Minyanville will be live-blogging the Abbott Meridia Advisory Committee meeting; join us for up-to-the-minute coverage.)
September 16
Arena Pharmaceuticals (ARNA) will face the Endocrinologic and Metabolic Drugs Advisory Committee where a panel of experts to the FDA will scrutinize the company's obesity drug lorcaserin. Analysts and investors believe that lorcaserin will have better luck than Vivus -- the safety profile has been shown to be far better than Qnexa. Yet some people worry that the committee will get hung up on the efficacy of the drug.
(Minyanville will be live-blogging the Arena Lorqess Advisory Committee meeting; join us for up-to-the-minute coverage.)
AstraZeneca (AZN) is waiting on a decision for its blood thinner Brilinta. The FDA is set to decide by September 16 whether or not the drug will hit the US market and be a competitor to Plavix (the second best-selling drug in the world with revenues over $6 billion annually). Brilinta has been shown to be more effective than Plavix in studies, but questions were raised about its effectiveness in North Americans – ultimately, an FDA advisory committee gave the go-ahead (but the FDA isn’t required to follow that decision).
Alkermes (ALKS) expects an approval decision for its opioid addiction treatment Vivitrol by October 12, but before this it will have to get past an FDA Advisory Committee on September 16. The drug is already approved as an injectible treatment for alcohol dependence. In November, the biotech announced positive results of a phase III study that showed Vivitrol helped patients stay off opioids, but the study was conducted in Russia and the FDA has concerns about how that will translate to US patients. But investors shouldn’t be too worried; this doesn’t seem like a large hurdle to overcome.
September 20-24
Bristol-Myers Squibb (BMY) and AstraZeneca will be in focus at the annual meeting of the European Association for the Study of Diabetes in Stockholm this year. The Big Pharma companies are expected to present late-stage data for their diabetes drug dapagliflozin. Hapoalim Securities analysts write, “The EASD meeting released a Phase III abstract for dapagliflozin versus glipizide, showing that, as add-on therapy, in patients with type 2 diabetes, dapagliflozin was non-inferior to glipizide at lowering HbA1c. Dapagliflozin continues to impress, and in our view will be the next major new way to treat type 2 diabetes."
Twitter: @biowriterchik
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