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Biogen, Teva, Other Drug Makers Face Stock Catalysts in October


Biogen Idec is expected to release key data on an MS drug, Teva faces an FDA panel and Bristol-Myers braces for a rejection for its diabetes drug.

October is shaping up to be an eventful month for biotech and drug stock catalysts. One of the most highly anticipated events for October is Biogen Idec's (BIIB) release of its late-stage clinical trial of an experimental multiple sclerosis pill BG-12.

The Biogen study tested the medicine against Teva Pharmaceutical Industries' (TEVA) Copaxone. Analysts expect the data to be released middle of the month. The results will give investors a sense of how big a drug BG-12 can be. Novartis' (NVS) Gilenya became the first oral MS drug approved in the US last year. If approved, Biogen's drug would compete with Gilenya. The Biogen study results will go along way toward influencing the medical and investor communities' views of the drug's potential.

Elsewhere, the Food and Drug Administration is expected to decide in October whether an experimental diabetes treatment developed by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN) should be approved in the US.

It would be a shocker if the drug, dapagliflozin, was approved given the thumbs down from government advisers in July due to safety concerns. (See Bristol-Myers, AstraZeneca Dealt Setback on Diabetes Drug) Otherwise, it's a relatively quiet month for FDA actions, though there have been surprises recently. The agency has been handing down decisions sooner than expected. For instance, Alexion Pharmaceuticals' (ALXN) Soliris was approved for expanded use this month even though an FDA ruling wasn't expected until October.

October also marks the beginning of earnings season as companies begin to release their third-quarter results. Check company websites for release dates and conference call information.

Here are some more highlights for this month. As always, the dates are subject to change.

October 17

Teva faces an FDA advisory panel that will consider the company's bid to expand use of its drug Azilect for treatment of Parkinson's patients.

October 21

A number of companies -- including Exelixis (EXEL), Medivation (MDVN), Optimer Pharmaceuticals (OPTR) and Sangamo BioSciences (SGMO), will present at BioCentury's NewsMakers in the Biotech Industry conference in New York.

October 28
Bristol and AstraZeneca are expected to hear from the FDA on possible approval of their diabetes treatment dapagliflozin.

Pacira Pharmaceuticals (PCRX) awaits word from the FDA on approval of the drug Exparel for pain management after surgery. The agency earlier this year delayed a decision on the drug. Pacira's stock has risen 40% since the company went public in February.

Merck (MRK) will announce its third-quarter earnings and hold a conference call.

Other potential catalysts:
Exelixis is expected to release key late-stage study data for its experimental drug cabozatinib for thyroid cancer. The company has said it will reveal the data early in the fourth quarter.

Teva hopes to gain clearance for its takeover of Cephalon (CEPH).
No positions in stocks mentioned.
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