September 25, 2007
On Friday, Bayer (NYSE: BAY ) and Onyx Pharmaceuticals (Nasdaq: ONXX ) moved one step closer to being able to market their cancer-fighting drug Nexavar for its second indication -- at least in Europe.
The European Committee for Medicinal Products for Human Use (CHMP) recommended that Nexavar be approved for treating liver cancer. CHMP is akin to an FDA advisory committee, in that the European Commission will take its recommendation into consideration when it takes action on the companies' application that was filed in June.
The companies also have a label-expanding application filled with the FDA. That application was given priority review status in August. So, based on the June application date, the companies should hear back from the FDA by the end of the year.
If you sense that there's a rush here, it's partially because the companies are trying to get as far ahead of Pfizer's (NYSE: PFE ) Sutent as they can. Sutent has been competing well against Nexavar in the kidney-cancer market, but it remains in phase 2 trials for liver cancer.
Given that the Nexavar trial was stopped early because the clinical trial data was so stunning, its FDA application will almost certainly be approved. The only real question is how quickly the agencies can process the applications so that they can start to market the drug. Some off-label sales may have already started, but being able to talk to oncologists about the drug's effectiveness in treating liver cancer should boost sales substantially. The new indication is especially important for Onyx, which currently relies completely on sales of Nexavar for its revenue. It would be wise to keep a close eye on the developments to come.