Shares of Onyx Pharmaceuticals soared Monday after it and its partner Bayer reported positive results from the final trial of a treatment for advanced liver cancer, paving the way for approval of the drug.
In an interview on CNBC, Onyx Chief Executive Hollings Renton said the company was meeting with regulators and expecting to file a supplementary application for approval of the drug, Nexavar, "as quickly as we can."
Earlier, German drugmaker Bayer said a study showed Nexavar significantly prolonged life for patients in the advanced stages of liver cancer.
The companies said 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. All patients enrolled in the trial would now have access to Nexavar, the cmpanies said.
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
Merck Finck analyst Carsten Kunold.
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.