It's been a long, slow summer in the biotech and drug sectors, butSeptember starts what should be a busy fall season, filled with stock-movingnews events.
Not to get anyone nervous, but there are billion of dollars on the linein the next few months. In the cancer drug arena, there will benot-to-be-missed news from
On the regulatory front, there will be plenty of action atthe Food and Drug Administration and its advisory panels. Medical meetingswill have Wall Street pros crisscrossing the country; while drug-coatedstents and their blockbuster sales potential will take center stage as thehottest commodity among followers of medical devices.
And if the news is good, the stars align and the overall marketcooperates (a lot of ifs, for sure) the biotech and drug sectors might justrebound from what has truly been an
for health careinvestors.
Here, then, a fall preview:
- AstraZeneca and its experimental cancer drug, Iressa, will be thecenter of attention at a FDA cancer-drug advisorypanel meeting on Sept. 24. This is a huge event: Iressa is the first of theclass of targeted cancer drugs known as EGF inhibitors to be reviewed by theFDA. AstraZeneca is seeking approval for Iressa as a last-resort treatment for lung cancerpatients who have exhausted all other medical options. But the Iressa story iscomplicated by the poor test results inless-sick lung cancer patients released last month.
- Does Avastin work or not? Investors will get some answers aboutGenentech's highly anticipated cancer drug later this month. (Click here for a primer on what to expect from thephase III breast cancer study.)
- The annual meeting of the Interscience Conference on AntimicrobialAgents and Chemotherapy takes over the San Diego Convention Center, Sept.27-30. From Wall Street's perspective, the meeting is not expected to yieldmajor news, with the exception of Versicor (VERS) , which will be presenting newdata on its lead antibiotic dalbavancin from a phase II clinical study.
- Gilead (GILD) - Get Gilead Sciences, Inc. (GILD) Report and Trimeris (TRMS) also will have a presence at the meeting,talking up their respective drugs, Adefovir for hepatitis B (now known asHepsera) and the AIDS drug T-20 (also known as Fuzeon.) And speaking ofAdefovir, the FDA is expected to issue its decision on the drug's approvalby Sept. 21.
- Another FDA advisory panel to watch: The Sept. 26-27 gathering of theEndocrinologic and Metabolic Drugs Advisory Committee. The panel will be reviewing competing drugs from Genzyme General (GENZ) and Transkaryotic Therapies (TKTX) for the treatment of Fabrydisease, a rare genetic disorder. While there aren't many people who sufferfrom Fabry disease, the treatments carry a price tag of about $175,000, sothe market opportunity for both companies is extremely rich. And this panelmeeting has some added drama because, due to orphan drug status rules, therestands a good chance that the FDA approves one drug and freezes out theother. Sounds a bit like "Survivor: The Biotech Edition."
- New Orleans is the site of this year's meeting of the American Collegeof Rheumatology, scheduled for Oct. 25-29. The biggest potential sleeper hitof this meeting will be the cancer drug Rituxan, which might just getanother shot at stardom thanks to some promising early data in rheumatoid arthritis. A full airing of this data willbe unwrapped at this meeting, which, if positive, could provide a nice liftto Genentech and partner Idec Pharmaceuticals (IDPH) . Amgen (AMGN) - Get Amgen Inc. Report, Johnson & Johnson (JNJ) - Get Johnson & Johnson (JNJ) Report and Abbott Laboratories (ABT) - Get Abbott Laboratories Report, and theirrespective rheumatoid arthritis drugs, also will make their presence felt atACR this year.
- Johnson & Johnson will release long-awaited data on its drug-coatedstent Cypher at the Transcatheter Cardiovascular Therapeutics medicalmeeting from Sept. 24-28. A stent is a wire-mesh tube inserted to keep apatient's arteries open after angioplasty. Cypher takes the technology onestep further, by adding a drug coating designed to better preventrestenosis, 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, aftermonths of ImClone news that focused only on the shenanigans of Sam Waksaland Martha Stewart, investors should see some actual clinical data on thedrug itself. ImClone's European partner, Merck KgaA, should releaseresults from a late-stage trial testing Erbitux on colon cancer patients bythe end of the year.
- CV Therapeutics (CVTX) is expected to file an approval applicationfor its heart drug, Ranolazine, by the end of the year. Genentech shouldalso have its FDA filings ready for the psoriasis treatment, Raptiva, andthe asthma drug, Xolair.