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updated: 9/27/2012 5:24 PM

Bayer, Onyx win FDA approval for cancer drug

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Bloomberg News

WASHINGTON -- Bayer, Germany's largest drugmaker, and Onyx Pharmaceuticals won regulatory approval Thursday for an advanced-colorectal cancer drug for patients whose disease progressed after trying standard therapies.

The Food and Drug Administration said in a statement Thursday that it cleared the treatment, called Stivarga, a month ahead of schedule. The two companies said they will jointly promote regorafenib in the United States, with South San Francisco-based Onyx receiving royalties of 20 percent on global sales of the drug.

Cancer that starts in the colon or rectum is the third-most common cancer in the U.S., excluding skin tumors, affecting about 140,000 men and women each year, according to the American Cancer Society. Stivarga may generate $536 million in sales in 2016 for Bayer and $251 million for Onyx, according to the averages of analyst estimates compiled by Bloomberg.

"Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients' lives and is the second drug approved for patients with colorectal cancer in the past two months," Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, said in the statement.

The FDA approved Zaltrap, made by Paris-based Sanofi and Regeneron Pharmaceuticals Inc. of Tarrytown, N.Y., for advanced colorectal cancer Aug. 3.

Onyx rose 2.6 percent to $84.64 at 4 p.m. New York time, adding to an 88 percent gain in the stock this year through Wednesday. Leverkusen, Germany-based Bayer climbed 1.3 percent to 68.40 euros.

People who took Stivarga lived a median 6.4 months longer, compared with five months for patients who were given a placebo and treatments for pain and other symptoms, Bayer said in a study presented in January.

Stivarga is approved with a boxed warning on severe and fatal liver toxicity.

Bayer also has asked the FDA to expand use of the drug to treat a form of stomach tumors in patients whose disease progressed despite taking other treatments. The drug has the potential to reach peak annual sales of 1 billion euros ($1.3 billion) with multiple approved uses, Bayer said in a December statement.

An estimated 103,000 Americans will develop colon cancer this year and 40,000 will get rectal cancer, according to the Atlanta-based American Cancer Society. The group said that about 52,000 people in the U.S. will die from the disease in 2012.

Excluding skin afflictions, the two most common types of cancer for men are of the prostate and lung, according to government data. For women, breast and lung cancer are the leading types.

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