BAYER, ONYX APPLY TO MARKET KIDNEY CANCER DRUG IN EU
German drugmaker Bayer and U.S. partner Onyx Pharmaceuticals have filed to market kidney cancer drug sorafenib in the European Union (EU).
Bayer has filed marketing authorization applications with the European Medicines Agency in London to market the drug in the EU. Bayer and Onyx are co-developing the drug.
In July, the drugmakers filed a new drug application with the FDA to market sorafenib for kidney cancer in the U.S. Bayer and Onyx hope to launch the drug in the U.S. during the first half of 2006.
The promising drug may help Bayer, inventor of aspirin, regain some of its lost edge in the pharmaceutical industry. Bayer's pharmaceutical division sales were flat in the second quarter due to generic competition for its antibiotic Cipro (ciprofloxacin). Another obstacle has been the ongoing litigation related to Bayer's withdrawn cholesterol drug Baycol (cerivastatin sodium), which so far has cost Bayer more than $1 billion.
Pfizer is also seeking FDA approval to market its kidney and stomach cancer drug, Sutent (sunitinib malate), which analysts say could eclipse rival sorafenib. Both drugs attack tumors by cutting off their blood supply. The FDA has granted both drugs fast-track status as drugs that could provide significant therapeutic benefits over existing therapies. Oncologists attending the annual American Society of Clinical Oncologists meeting in May named sorafenib and Sutent "two of the most impressive treatments in clinical trials," according to a survey recently released by market research firm Market Strategies.