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VIDEOUpcoming Catalysts for Biotech Stocks
Vivus, Arena, and Javelin among others are facing stock-moving events this fall.
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Late August/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 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.
October 3Javelin Pharmaceuticals' (HSP) Dyloject for the treatment of moderate to severe pain, mostly used after operations, will face approval by the FDA. It will be the first non-steroidal anti-inflammatory approved for this purpose in 20 years.
October 11
Alexza Pharmaceuticals (ALXA) is awaiting approval of it schizophrenia drug AZ-004. The drug is an inhaled formulation of the drug loxapine. The Canadian biotech Biovail (BVF) acquired the right to the drug in February and will market it in North America if it gets approved. Analysts believe the drug could have a market of $500 million.
Jazz Pharmaceuticals (JAZZ) will also face an FDA decision on this day for its fibromyalgia drug JZP-6. The drug will be scrutinized by the Arthritis and Drug Safety and Risk Management Advisory Committees on August 20. The drug is already approved for the treatment of narcolepsy. The drug is highly susceptible to abuse; this could become an issue at the committee meeting.
October 12Alkermes (ALKS) expects an approval decision for its opioid addiction treatment Vivitrol on this date. The drug is already approved as an injectible treatment for alcohol dependence. In November, the biotech announced positive results of a phase 3 study that showed Vivitrol helped patients stay off opioids.
October 22
Later in the month, Alkermes will face the FDA again, along with Eli Lilly (LLY) and Amylin Pharmaceuticals (AMLN). The companies will be looking for the approval of Bydureon -- the long-acting formulation of their diabetes drug Byetta. The once-weekly injectible was passed over once by the regulatory agency, which wanted more information on the risks of the drug. It will face stiff competition from Novo Nordisk's (NVO) Victoza if it finally gets to market. Victoza has gained 27% of the GLP-1 market since it was approved in January.
Arena's obesity drug will face approval on this day as well. The approval of the drug will be contingent on how well the advisory committee meeting goes in September. While the FDA isn't required to follow the decisions of its advisory committees, it often does.
October 28
The FDA will make its decision on Vivus' Qnexa. An advisory panel to the FDA voted against approval in July. The panel thought that risks surrounding pregnancy and cardiovascular issues were too great to allow the drug to reach the market without more testing.Twitter: @biowriterchik
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