A decent article from TSC on what's upcoming in biotech. It omits a significant near-term regulatory event - the FDA decision on MEDI's 'flu vaccine. (We'll find out by the end of the month whether the FDA will be giving it a 2 month or 6 month review. The 2 month review still gives them a small shot at launching this 'flu season.)
Billions at Stake in Biotech's Fall Season
By Adam Feuerstein
Senior Writer
09/05/2002 07:08 AM EDT
It's been a long, slow summer in the biotech and drug sectors, but September starts what should be a busy fall season, filled with stock-moving news events.
Not to get anyone nervous, but there are billion of dollars on the line in the next few months. In the cancer drug arena, there will be not-to-be-missed news from AstraZeneca (AZN:NYSE - news - commentary - research - analysis), Genentech (DNA:NYSE - news - commentary - research - analysis) and ImClone Systems (IMCL:Nasdaq - news - commentary - research - analysis).
On the regulatory front, there will be plenty of action at the Food and Drug Administration and its advisory panels. Medical meetings will have Wall Street pros crisscrossing the country; while drug-coated stents and their blockbuster sales potential will take center stage as the hottest commodity among followers of medical devices.
And if the news is good, the stars align and the overall market cooperates (a lot of ifs, for sure) the biotech and drug sectors might just rebound from what has truly been an annus horribilis for health care investors.
Here, then, a fall preview:
AstraZeneca and its experimental cancer drug, Iressa, will be the center of attention at a FDA cancer-drug advisory panel meeting on Sept. 24. This is a huge event: Iressa is the first of the class of targeted cancer drugs known as EGF inhibitors to be reviewed by the FDA. AstraZeneca is seeking approval for Iressa as a last-resort treatment for lung cancer patients who have exhausted all other medical options. But the Iressa story is complicated by the poor test results in less-sick lung cancer patients released last month.
Does Avastin work or not? Investors will get some answers about Genentech's highly anticipated cancer drug later this month. (Click here for a primer on what to expect from the phase III breast cancer study.)
The annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy takes over the San Diego Convention Center, Sept. 27-30. From Wall Street's perspective, the meeting is not expected to yield major news, with the exception of Versicor (VERS:Nasdaq - news - commentary - research - analysis), which will be presenting new data on its lead antibiotic dalbavancin from a phase II clinical study.
Gilead (GILD:Nasdaq - news - commentary - research - analysis) and Trimeris (TRMS:Nasdaq - news - commentary - research - analysis) also will have a presence at the meeting, talking up their respective drugs, Adefovir for hepatitis B (now known as Hepsera) and the AIDS drug T-20 (also known as Fuzeon.) And speaking of Adefovir, the FDA is expected to issue its decision on the drug's approval by Sept. 21.
Another FDA advisory panel to watch: The Sept. 26-27 gathering of the Endocrinologic and Metabolic Drugs Advisory Committee. The panel will be reviewing competing drugs from Genzyme General (GENZ:Nasdaq - news - commentary - research - analysis) and Transkaryotic Therapies (TKTX:Nasdaq - news - commentary - research - analysis) for the treatment of Fabry disease, a rare genetic disorder. While there aren't many people who suffer from Fabry disease, the treatments carry a price tag of about $175,000, so the market opportunity for both companies is extremely rich. And this panel meeting has some added drama because, due to orphan drug status rules, there stands a good chance that the FDA approves one drug and freezes out the other. Sounds a bit like "Survivor: The Biotech Edition."
New Orleans is the site of this year's meeting of the American College of Rheumatology, scheduled for Oct. 25-29. The biggest potential sleeper hit of this meeting will be the cancer drug Rituxan, which might just get another shot at stardom thanks to some promising early data in rheumatoid arthritis. A full airing of this data will be unwrapped at this meeting, which, if positive, could provide a nice lift to Genentech and partner Idec Pharmaceuticals (IDPH:Nasdaq - news - commentary - research - analysis). Amgen (AMGN:Nasdaq - news - commentary - research - analysis), Johnson & Johnson (JNJ:NYSE - news - commentary - research - analysis) and Abbott Laboratories (ABT:NYSE - news - commentary - research - analysis), and their respective rheumatoid arthritis drugs, also will make their presence felt at ACR this year.
Johnson & Johnson will release long-awaited data on its drug-coated stent Cypher at the Transcatheter Cardiovascular Therapeutics medical meeting from Sept. 24-28. A stent is a wire-mesh tube inserted to keep a patient's arteries open after angioplasty. Cypher takes the technology one step further, by adding a drug coating designed to better prevent restenosis, or the reclogging of arteries. J&J will be presenting data on the rate of restenosis in a 1,100-patient U.S. clinical study known as SIRIUS. Cypher has been approved in Europe. An FDA advisory panel will review the device on Oct. 22, with a full FDA decision possibly coming by the end of the year.
Remember Erbitux, the supposed blockbuster cancer drug? Finally, after months of ImClone news that focused only on the shenanigans of Sam Waksal and Martha Stewart, investors should see some actual clinical data on the drug itself. ImClone's European partner, Merck KgaA, should release results from a late-stage trial testing Erbitux on colon cancer patients by the end of the year.
CV Therapeutics (CVTX:Nasdaq - news - commentary - research - analysis) is expected to file an approval application for its heart drug, Ranolazine, by the end of the year. Genentech should also have its FDA filings ready for the psoriasis treatment, Raptiva, and the asthma drug, Xolair.
Peter |
