Bloomberg News

Onyx Falls After FDA Rejects Faster Review for Cancer Drug

December 14, 2011

(Updates shares in first and second paragraphs.)

Dec. 12 (Bloomberg) -- Onyx Pharmaceuticals Inc., maker of the kidney cancer drug Nexavar, dropped the most in about six weeks after U.S. regulators declined to give the company’s experimental carfilzomib an accelerated review.

Onyx fell 4 percent to $39 at the close of trading in New York, its largest single-day decline since Nov. 1. Shares of the South San Francisco, California-based company have increased 5.8 percent this year.

The Food and Drug Administration said Onyx hadn’t conducted the clinical trials necessary for the quicker review of carfilzomib, the company said yesterday in a statement. The agency scheduled a target date of July 27, four months later than under an accelerated approval, to decide whether to clear the drug for patients with multiple myeloma, a cancer of plasma cells, Onyx said. The company submitted its application in September.

“We are surprised by the FDA’s timeline, but remain confident that carfilzomib will be approved and recommend purchase of Onyx on weakness,” Gene Mack, an analyst with Mizuho Securities in New York, wrote in a research note today.

Mack said he anticipates an oncology drug advisory panel to review the medicine in June, and lowered his estimate for 2012 sales to $50 million from $70 million because of the delay.

“We feel comfortable that we have addressed the key risks and that this is a compound that deserves to be approved either on an accelerated basis or a full basis,” Chief Executive Officer Tony Coles told analysts on a conference call today. “Carfilzomib could become an integral part of the treatment options available to multiple myeloma patients.”

Ted Love, Onyx’s head of research and development, said the company was preparing for a panel hearing, and that Onyx didn’t yet know if the FDA would require one.

--Editors: Andrew Pollack, Bruce Rule

To contact the reporters on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net; Meg Tirrell in New York at mtirrell@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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