Onyx, Bayer expect new Nexavar decision by Dec. 25
Onyx Pharmaceuticals and Bayer said Tuesday that regulators will conduct a faster review of their pill Nexavar as a treatment for thyroid cancer.
The Food and Drug Administration is reviewing Nexavar as a treatment for locally advanced or metastatic thyroid cancer that doesn't respond to treatment with radioactive iodine. The companies said the FDA expects to complete its review by Dec. 25.
Nexavar is approved as a treatment for inoperable liver cancer and advanced kidney cancer. Onyx and Bayer market the drug together, and sales in 2012 totaled $861 million. The companies are also studying Nexavar as a treatment for breast cancer.
On Sunday, Amgen Inc. said it would buy Onyx for about $10.4 billion, or $125 per share. Onyx's other approved drugs are Stivarga, which is approved as a treatment for colorectal cancer and tumors of the intestinal tract that did not respond to other treatments, and Kyprolis, which was recently approved as a treatment for multiple myeloma, a cancer of the blood. Onyx and Bayer AG also market Stivarga together.
Amgen is the biggest biotech drug company in the world. Its sales totaled $17.27 billion in 2012. The companies expect the deal to close early in the fourth quarter.
Shares of Onyx Pharmaceuticals Inc. slipped 4 cents to $123.45 in morning trading.
Germany-based Bayer AG does not trade on the major U.S. markets.