Biotech Investors, Mark Your Calendars

Labor Day is upon us, which means summer is over and Wall Street can get back to work. Given their grounding in academia, the biotech and drug sectors tend to take the summer off, but that will change with September bringing the start of the school year.

As measured by the Amex Biotech Index, biotech stocks had a pretty good August, up 3% and outperforming the Nasdaq Composite. Whether the sector can maintain this momentum will largely depend on the outcome of a fall calendar filled with anticipated Food and Drug Administration decisions, clinical trial data releases and important medical meetings.

Here, then, is a calendar (lengthy, but not necessarily exhaustive) of important events in the biotech and drug sectors for the next four months:

September

  • AstraZeneca (AZN): An FDA advisory panel will review AstraZeneca's blood-thinning drug Exanta on Sept. 10. The European drugmaker has a lot riding on getting Exanta approved here (it's already approved in Europe). Peak sales forecasts for the drug top $3 billion, which is revenue AstraZeneca desperately needs to replace slumping sales of former blockbuster drugs like the ulcer pill Prilosec, which has gone the way of cheap generics. But Exanta's approval is not a slam dunk by any means. While Exanta has some big advantages over Warfarin, the most commonly prescribed blood thinner, Exanta also comes with potentially serious side effects of its own, namely liver toxicity. The FDA advisory panel will be charged with sorting out all the issues and voting on whether to recommend Exanta for approval or not.
  • Meet and greet: The fall means banking conference season starts up again, and that gives drug and biotech firms a chance to strut their stuff in front of institutional money managers. BioCentury, a biotech trade magazine, and Thomson Financial are sponsoring the 11th annual Newsmakers in the Biotech Industry meeting on Sept. 9. Bear Stearns and UBS Securities hold their own health care investment conferences, Sept. 13-14 and Sept. 27-30, respectively.
  • Connetics (CNCT): The FDA is set to issue its approval decision Sept. 26 for Extina, the company's potential new skin treatment for seborrheic dermatitis.
  • Allergan (AGN): The FDA is also set to issue an approval decision on Sept. 26 for Tazoral, the company's oral drug to treat psoriasis. Recall, however, that an FDA advisory panel on July 12 voted to recommend that the agency not approve the drug.
  • Valentis (VLTS): Top-line data are expected to be released in the last week of September from an important phase II study (dubbed "Delta-1") of the company's lead drug, Deltavasc. It is being developed as a treatment for peripheral arterial disease, which manifests itself as poor blood flow in the arteries.
  • AtheroGenics (AGIX): Shares in this company will rise much higher -- or sink an equal amount -- on the basis of results from a phase II study of its lead heart drug, AGI-067, which is being developed to treat atherosclerosis (the narrowing of arteries caused by the buildup of fatty deposits). AtheroGenics is expected to release results from the "CART-2" study before the end of the third quarter, possibly at the end of September. AtheroGenics has been wooing Big Pharma to sign a partnership, so results from this AGI-067 study will go a long way toward helping or hurting a deal.
  • Maxim Pharmaceuticals (MAXM): Results of a pivotal phase III study of its melanoma (skin cancer) drug Ceplene are expected at the end of September, at the earliest.
  • Cancer conference: The European Organization for the Research and Treatment of Cancer holds a closely watched meeting in Geneva Sept. 28-Oct. 1. While much of the cancer research presented at this meeting is early stage, Wall Street still attends, and that will put an investor spotlight on cancer drug stocks.
  • Biogen Idec (BIIB) and Elan Pharmaceuticals (ELN): Much of the attention focused on the companies' experimental drug Antegren has been on its use in multiple sclerosis, but Antegren is also a promising drug for Crohn's disease, a gastrointestinal ailment. New Antegren data in Crohn's will be presented at a European gastroenterology meeting on Sept. 29.
  • October

  • Biogen Idec and Elan: The companies have already announced -- with some controversy -- that they will not be presenting Antegren data at the annual meeting of the European Committee for the Treatment and Research of Multiple Sclerosis Oct. 6-9 in Vienna. But that doesn't mean Antegren won't be discussed at this closely watched medical meeting.
  • Amgen (AMGN) and NPS Pharmaceuticals (NPSP): Both companies will be making their presence felt at the annual meeting of the American Society of Bone and Mineral Research, being held Oct. 1-5. Amgen is developing AMG-162 for osteoporosis, one of the biotech giant's most promising late-stage drug candidates. NPS Pharma is expected to file its osteoporosis drug, Preos, with the FDA by the end of the year.
  • La Jolla Pharmaceuticals (LJPC): The FDA is expected to issue an approval decision by Oct. 16 for the company's lupus drug, Riquent.
  • Genentech (DNA) and Biogen Idec: Rituxan is already a blockbuster cancer drug, and now these companies are trying to expand the drug's use to treat rheumatoid arthritis. While there won't be much in the way of important new data on Rituxan presented at the American College of Rheumatology meeting Oct. 17-21, the drug will get some buzz nonetheless.
  • AstraZeneca: The FDA is expected to issue its approval decision on the blood-thinning drug Exanta on Oct. 23. (See the above-mentioned discussion of the Sept. 10 FDA advisory panel.)
  • Shire Pharmaceuticals (SHPGY): The FDA will rule on the approvability of Fosrenol on Oct. 26. Fosrenol is being developed for use in patients with end-stage kidney disease. If Fosrenol is approved for use in the U.S., that would affect Genzyme's (GENZ) competing drug, Renagel.
  • Merck (MRK): The FDA is expected to issue an approval decision on Arcoxia, Merck's next-generation painkiller. Arcoxia is a new drug in the class of blockbuster painkillers known as Cox-2 inhibitors, which include Merck's Vioxx and Pfizer's (PFE) Celebrex. But Merck has been hurt recently by concerns about heart problems in patients taking Vioxx.
  • November

  • Heart confab: The annual scientific meeting of the American Heart Association runs Nov. 7-10 in New Orleans. This is one of the most important medical meetings of the year. Look for news from Pfizer regarding expanded use of Viagra in pulmonary arterial hypertension, as well as important data from Valentis, Atherogenics, Corgentech (CGTK) and NitroMed (NTMD).
  • Biogen Idec and Elan: The FDA is expected to issue its approval decision on the multiple sclerosis drug Antegren on Nov. 25.
  • December

  • Blood cancer in the spotlight: The American Society of Hematology holds its annual meeting Dec. 1-4, which highlights drug and biotech companies developing treatments for blood-related illnesses, including cancer. Genentech always has a big role at this meeting; this year Genta (GNTA) is also expected to finally release data from another two pivotal phase III studies of its cancer drug Genasense. Efforts to get Genasense approved for use in skin cancer failed earlier this year.
  • Sepracor (SEPR): An FDA decision is expected Dec. 15 on the approvability of Estorra, the company's insomnia drug. Sepracor received an "approvable" letter from the FDA for Estorra in February, requesting additional information before the drug could receive final approval.
  • Eyetech Pharmaceuticals (EYET) and Pfizer: The FDA is expected to issue an approval decision Dec. 17 for Macugen, the companies' drug to treat wet age-related macular degeneration. An FDA advisory committee earlier this month reviewed the drug favorably.
  • Genzyme and Bioenvision (BIVN): The FDA is expected to rule on the approvability of their cancer drug Clofarabine on Dec. 30.
  • It's going to be a busy fall, so rest up over the holiday weekend.


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    Adam Feuerstein writes regularly for RealMoney.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. He invites you to send your feedback to adam.feuerstein@thestreet.com.

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