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Amgen, Vivus, Chelsea Therapeutics Prep for Key Catalysts in February


The biotechs face FDA panels as they push for market approval of their drugs. Watson Pharmaceuticals, others await word on US decisions.

January was chock full of big news for biotech and drug companies with drug approvals, acquisitions and a host of other items of interest to investors.

There are several events in February that will help determine whether new drugs reach the US market. Diet pill maker Vivus (VVUS) will go before a Food and Drug Administration panel of experts as the company tries again to sway US officials to approve its drug Qnexa. Also, the trade group Biotechnology Industry Organization holds an investor conference in New York, which will feature a number of company presentations.

Some of the month's highlights are listed below. Dates are subject to change.

February 8
Amgen (AMGN) will face an FDA panel reviewing the drug Xgeva for treatment of men with advanced prostate cancer. Amgen wants to win a new use for the treatment -- preventing prostate cancer from spreading to a patient's bones. The drug is already approved to reduce bone fractures in cancer patients and to treat osteoporosis in women.

February 9
Neurogesx (NGSX) will face a panel of FDA advisers who will discuss the small-cap company's application to sell its Qutenza Patch for nerve pain in HIV patients. The product already is approved to treat pain related to shingles.

February 13
The two-day Bio CEO & Investor Conference begins in New York. The event bills itself as the largest investor conference focused on publicly traded biotech companies.

February 17
Corcept Therapeutics (CORT) expects to hear word on US approval of its drug Korlym for the treatment of the rare hormonal disease Cushing's Syndrome. There's no drug approved for the disorder. Korlym is actually a new name for the older drug mifepristone, aka the "morning after pill" used to terminate pregnancy.

February 22
Vivus goes before an advisory committee of the FDA for a second time as it tries to win approval for its diet drug Qnexa. Vivus is one of three companies -- along with Arena Pharmaceuticals (ARNA) and Orexigen Therapeutics (OREX) -- attempting to sell the first new weight-loss drug in the US in more than a decade. (See Diet Pill Scorecard: Vivus, Arena, Orexigen Still Chasing Market Approvals.) The FDA has been very cautious about the safety of these drugs. Vivus would market the drug to men and women who are unlikely to become pregnant due to concern over potential birth defects.

February 23
Chelsea Therapeutics (CHTP) will try to convince an FDA panel that its drug Northera should be approved to treat neurogenic orthostatic hypotension, or NOH, in patients with Parkinson's disease and other nervous system disorders. NOH is a condition that can cause dizziness, fatigue and fainting.

February 26
Watson Pharmaceuticals (WPI) and Columbia Laboratories (CBRX) expect a decision on possible US approval of the drug Prochieve to reduce the risk of preterm births. The odds don't appear to be in the companies' favor. An FDA panel recommended rejecting the drug's market application and the agency's staff was critical of the product. (See FDA Staff Critical of Treatment to Reduce Preterm Births.)

While most of the largest drug and biotech companies already announced quarterly earnings in January, some companies still have yet to report. For instance, Human Genome Sciences (HGSI), which pre-announced disappointing fourth-quarter sales of its lupus drug Benlysta, has not yet disclosed full results. Regeneron (REGN), which announced robust early sales of its new drug Eylea, plans to report earnings on February 16.

Twitter: @brettchase

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