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Top 10 Biotech Events to Watch 2009.03  

2009-03-06 18:03:56|  分类: Bio-Pharma |  标签: |举报 |字号 订阅

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Adam Feuerstein

Between now and the end of April, I count 10 big events with biotech stock-moving potential on the calendar. We all know that the health of the biotech group can swing on sentiment, so the outcomes of these 10 events could set the course for the sector as we transition from winter to spring.

Don't expect all of these events to result in happy endings. This is biotech, after all, which translated into Sanskrit means "high-risk of failure." [I bet you didn't know I spoke Sanskrit.] But hopefully, we'll get enough good news in the next eight weeks to put investors in a giving mood that pushes the biotech sector back out front of the market where it belongs.

Here are my 10 biotech events, listed in a subjective order of importance:

1. Adjuvant Avastin: The fate of the Roche takeover bid for Genentech(DNA Quote - Cramer on DNA - Stock Picks) may rest on the outcome of a single clinical trial. Genentech expects results in April from a large study of colon cancer patients treated with Avastin in the post-surgery, or adjuvant, setting. A positive outcome sets Genentech on the path toward another $5 billion in Avastin revenue and all but guarantees that Roche will have to make a serious upward adjustment to its $86.50-a-share bid if it wants to complete the acquisition.

2. Provenge: Are we all tired of Dendreon(DNDN Quote - Cramer on DNDN - Stock Picks) yet? If not, then this event is for you. "Final" results from the phase III study of the company's Provenge cancer vaccine in prostate cancer patients are due in April. I put "final" in quote because with Dendreon, no event, no matter how large, ever seems to be able to put this story to bed

3. Obesity, take three: Arena Pharmaceuticals(ARNA Quote - Cramer on ARNA - Stock Picks) should be releasing results by the end of March from a phase III study of obesity drug lorcaserin. We've seen phase III data from Vivus(VVUS Quote - Cramer on VVUS - Stock Picks) and Orexigen Therapeutics(OREX Quote - Cramer on OREX - Stock Picks) (both obesity drug competitors to Arena) this year already, neither of which impressed much. Will Arena's drug be the winner?

4. Multiple sclerosis pills: The American Academy of Neurology annual meeting, being held April 25-May 2 in Seattle, will be where drugmakers Novartis(NVS Quote - Cramer on NVS - Stock Picks) and Merck KGaA present data on their respective oral pills for multiple sclerosis. The data from these drugs have important implications for multiple sclerosis patients, who would probably flock to a pill over the regular injections required today to keep their disease at bay. But from the biotech angle, Biogen Idec(BIIB Quote - Cramer on BIIB - Stock Picks) and Elan(ELN Quote - Cramer on ELN - Stock Picks) would also be affected because they market two of the leading injectable drugs for multiple sclerosis.

5. United Therapeutics(UTHR Quote - Cramer on UTHR - Stock Picks): Setbacks and delays to the company's efforts to develop an oral version of its mainstay drug Remodulin for patients with pulmonary arterial hypertension (PAH) have magnified the importance of parallel work on an inhaled form the drug. The U.S. Food and Drug Administration is currently reviewing inhaled Remodulin, with an approval decision expected on April 30.

6. A better interferon for hepatitis C: Later this month, Human Genome Sciences(HGSI Quote - Cramer on HGSI - Stock Picks) will release results from an important phase III study of its long-acting interferon, Albuferon, in patients with genotype 1 hepatitis C, the most common form of the disease in the U.S. and Europe. Albuferon is dosed every two weeks instead of once weekly for currently prescribed long-acting interferons.

7. Diabetes: The FDA is convening an advisory committee meeting April 2-3 to review liraglutide, a once-daily injectable diabetes drug developed by Novo Nordisk. Safety, particularly the risk of pancreatitis associated with liraglutide and other drugs in the so-called GLP-1 class, will probably be topic No. 1 at the meeting. Amylin Pharmaceuticals(AMLN Quote - Cramer on AMLN - Stock Picks) will see some activity around this FDA meeting as well, since the company sells a competing GLP-1 diabetes drug, Byetta, and is developing a longer-acting version of the drug.

8. Still more hepatitis C: The European Association for the Study of Liver Disease, scheduled for April 22-26, is one of two major hepatitis C drug meetings held each year. As with meetings past, this year's EASL will be where companies like Vertex Pharmaceuticals(VRTX Quote - Cramer on VRTX - Stock Picks) and InterMune(ITMN Quote - Cramer on ITMN - Stock Picks) show off the latest data on their experimental hepatitis C drugs.

9. Discovery Labs(DSCO Quote - Cramer on DSCO - Stock Picks): Can this drug maker finally convince the FDA to sign off and approve Surfaxin, a treatment for the prevention of respiratory distress in premature infants? Discovery has tried three times previously to obtain Surfaxin's approval, so perhaps shot No. 4 will be the one that finally gets the drug across the finish line. We'll know on April 17.

10. Dyax(DYAX Quote - Cramer on DYAX - Stock Picks): Another FDA approval decision date, this time March 23, for Dyax's DX-88, which the company seeks to market as a treatment for hereditary angioedema. In early February, an FDA advisory panel voted by a narrow margin to recommend DX-88's approval.

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