Bayer to file for Nexavar approval for liver cancer
FRANKFURT (Reuters) - German drugmaker Bayer <BAYG.DE> plans to file this year for market approval for Nexavar to treat liver cancer after a study showed the drug significantly prolongs life for patients in the advanced stages of the disease.
The German firm and its U.S. partner Onyx Pharmaceuticals <ONXC.PK> said on Monday the study had been stopped after a review by an independent data monitoring committee showed the pivotal Phase III trial had met its primary aims.
Bayer and Onyx said all patients enrolled in the trial would now have access to Nexavar.
Both companies want to file for market approval this year for Nexavar's use in treating liver cancer in the United States and Europe, where it is already approved for the treatment of advanced kidney cancer.
Analysts were optimistic the drug would gain the extended approval.
"We are quite confident that Nexavar will be approved for the treatment of primary liver cancer based on the positive statements from the independent data monitoring committee," said
Bayer shares were down 0.5 percent at 44.37 euros by 0923 GMT, outperforming the German DAX index <.GDAXI>, which was down 0.8 percent.
Liver cancer is the fifth most common cancer in the world and is often seen as difficult to treat.
Bayer has said it expects peak sales of about 500 million euros ($649.6 million) from Nexavar in the treatment of kidney, liver and skin cancer. If approved for other cancers such as lung cancer, the firm has said the drug could generate sales of around 1 billion euros.
In the third quarter of 2006, Bayer saw Nexavar sales of 37 million euros and for the full year the firm expects more than 100 million euros in revenue from the drug.
