Bayer HealthCare Pharmaceuticals said its foray into the oncology business is showing progress, supported by regulatory approvals and promising clinical trials.
The New Jersey-based division of Bayer AG showcased its oncology portfolio last weekend at the annual meeting of the American Society of Clinical Oncology, in Chicago.
Bayer shared results from late-stage on clinical trials on Nexavar, a drug being developed to treat thyroid cancer. Nexavar, which is being co-developed with Onyx Pharmaceuticals Inc., already is approved to treat kidney and liver cancer.
Bayer plans to use new data showing effectiveness of Nexavar for certain thyroid cancer as a basis for filing a new drug approval from the U.S. Food and Drug Administration later this year. Additional submissions are planned for global markets.
Bayer has also begun late-stage clinical trials of applying Stivarga to treat liver cancer. Stivarga received FDA approval in September to treat metastatic colorectal cancer, a form of colon cancer. The drug also treats gastrointestinal stromal cancer.
Progress on Nexavar and Stivarga follow the FDA's approval last month of Xofigo, which treats patients with castration-resistant prostrate cancer that has spread to the bone.
Bayer, a company long known for aspirin, said the developments bode well for its nascent oncology business, which the company formed in 2005.
"The velocity at which we are quickly turning into a significant oncology player is remarkable," said Shannon Campbell, vice president and general manager of Bayer's oncology business, in prepared comments. "We are very excited about it."
Campbell said it's too early to project revenue from its oncology drugs, but the company believes Nexavar has blockbuster potential and "we certainly have very high expectations and aspirations for Stivarga, as well."
Bayer HealthCare is in the process of centralizing area operations from four sites — in Wayne, Montville and Morristown, in New Jersey, plus a building Tarrytown, N.Y. — to one location in the Whippany section of Hanover. Spokeswoman Rosemarie Yancosek said the consolidation is planned for completion later this year.