Onyx Shares Fall on Cancer Drug Filing

	Tweet

Shares of Onyx Pharmaceuticals Inc. plunged after it and partner Bayer Pharmaceuticals Corp. said Monday they will use ongoing late-stage clinical trial data to seek marketing approval of their kidney cancer treatment rather than using mid-stage clinical trial results.

Shares of Onyx fell $11.02, or 27 percent, at $29.79 Nasdaq. American depositary receipts of Bayer AG, Bayer Pharmaceuticals parent company, fell 32 cents, or 1.1 percent, to $27.85.

The decision to use the mid-stage data to support late-stage clinical trial data, which is still being enrolled, puts a possible U.S. launch date into 2006, later than if the companies would have started the filing process with mid-stage data. The Phase III study is expected to enroll more than 800 patients with the primary endpoint being overall patient survival.

The Phase II clinical study showed that patients treated with the drug BAY 43-9006 were more likely not to have progression of their disease than those on placebo during 12 weeks of treatment.

The companies said 70 percent of patients in the study had tumor shrinkage or disease stabilization but that the study had been designed to look tumor stabilization, not tumor shrinkage.

RELATED STORIES:
Researchers Discover New Effect for Insulin   New Antibiotic Shortens Tuberculosis Treatment Time   Paxil Results Depressing Some Americans   Drug Companies Issue Michael Moore Warning   Roswell Park research aids development of myeloma drug   Statins may cut stroke disability, deaths   Statins do not prevent cancer, study says   Blood Pressure Drug Approved to Counter Heart Failure   Chinese to get easier access to ED drugs   FDA clears next-generation schizophrenia pill   FDA’s new statin label warning about diabetes risk may have little effect   Doctors question safety of U.S. drugs

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]