Bloomberg News

Onyx Wins U.S. FDA Approval for Blood Cancer Treatment

July 20, 2012

Onyx Wins U.S. Regulatory Approval of Blood Cancer Therapy

“We think this is just terrific for patients,” Onyx Pharmaceuticals Inc.’s Chief Executive Officer Tony Coles said in a telephone interview today. “We are prepared to launch, we have all the necessary plans in place.” Photographer: Jeremy Bales/Bloomberg

Onyx Pharmaceuticals Inc. (ONXX:US)’s treatment for a deadly blood cancer won U.S. approval, giving the company its first wholly owned drug to sell.

The medicine, called Kyprolis, was cleared for patients who have received two prior therapies, the Food and Drug Administration said today in a statement. Annual sales may be $682.7 million in 2016, according to the average of six analysts’ estimates (ONXX:US) compiled by Bloomberg, more than doubling the South San Francisco, California-based company’s $447 million revenue last year.

“We think this is just terrific for patients,” Chief Executive Officer Tony Coles said in a telephone interview today. “We are prepared to launch, we have all the necessary plans in place.”

Hospitals and clinics will be able to order the medicine by Aug. 1, which will then be available within 24 hours, Helen Torley, Onyx’s chief commercial officer said today on a company conference call. The therapy will cost $9,950 for a 28-day cycle, she said. The median time patients were taking the drug in a study was 4.4 months and Onyx estimates a cost of $40,000 for treatment.

Onyx gained (ONXX:US) 12 percent to $76.38 at the close in New York. Ligand Pharmaceuticals Inc., which has an agreement to explore an IV version of the drug, fell less than 1 percent to $17.51.

FDA advisers voted 11-0, with one abstention, in June that the benefits of Onyx’s multiple myeloma treatment, also known as carfilzomib, outweigh its risks. Onyx had applied for accelerated approval of the treatment based on the second of three phases of trials typically needed for market clearance.

Attacks Tumors

The medicine shrunk tumors in 22 percent of multiple myeloma patients. Side effects for the treatment included cardiac arrest, chest pain, pneumonia and shortness of breath, the FDA staff said in a report last month. More than 70 percent of patients had lung complications with the drug, according to the FDA report.

Kyprolis would be used to treat multiple myeloma patients who have first tried Celgene Corp.’s (CELG:US) Revlimid and Takeda Pharmaceutical Co. Ltd.’s (4502) Velcade.

About 50,000 people in the U.S. are living with the disease and 20,000 new cases are diagnosed each year. About 11,000 patients die of the blood cancer annually, according to the National Cancer Institute.

“This is great news for patients, great news for Onyx, they really did a bang-up job with this drug,” Michael King, an analyst with Rodman & Renshaw in New York, said in an e-mail.

Onyx, founded in 1992, focuses on developing cancer treatments. The company’s only other approved product is Nexavar, a kidney-and-liver-cancer drug it markets in collaboration with Bayer AG. (BAYN) Globally, Nexavar sales reached $1 billion last year, with Onyx recording $287 million in revenue from the medicine, according to a filing.

To contact the reporter on this story: Ryan Flinn in San Francisco at

To contact the editor responsible for this story: Reg Gale at

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Companies Mentioned

  • CELG
    (Celgene Corp)
    • $117.18 USD
    • 0.70
    • 0.6%
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