Tags: onyx | fda | cancer | drug

Onyx Shares Soar as FDA Panel Clears Cancer Drug

Thursday, 21 June 2012 09:48 AM

Shares of Onyx Pharmaceuticals Inc. rose 40 percent in early trading Thursday after winning support from a U.S. advisory panel for its drug to treat a deadly blood cancer that affects 50,000 Americans.

Onyx jumped to $62.15 at 7:34 a.m. New York time, after gaining 29 percent in the 12 months before Thursday. Ligand Pharmaceuticals Inc., which has an agreement with Onyx to explore an IV version of the medicine, increased 6.5 percent to $15.49 in early trading.

Food and Drug Administration advisers voted 11 to 0, with one abstention, that the benefits of Onyx’s multiple myeloma treatment, called carfilzomib, outweigh its risks. If approved by the agency, annual sales may be $523 million in 2016, according to the average of five analysts’ estimates compiled by Bloomberg, more than doubling the South San Francisco-based company’s $447 million revenue last year.

“This is an unmet need in a group that has really run out of options,” said Wyndham Wilson, the panel chairman and chief of lymphoma therapeutics at the National Cancer Institute. “There is a pretty convincing signal here that is likely, I believe, to be confirmed in confirmatory trials.”

The agency, scheduled to make a decision by July 27, isn’t required to follow the recommendation of the panel, which met yesterday in Silver Spring, Maryland. Onyx applied for accelerated approval of the treatment based on the second of three phases of trials typically needed for market clearance.

Tumors Shrunk

The medicine, with the proposed name Kyprolis, shrunk tumors in 22 percent of multiple myeloma patients, which may not offer enough of an advantage in light of the side effects, FDA staff said in a June 18 report.

Five patients died from heart ailments, the agency said. If approved, annual sales for the drug may be $523 million in 2016, according to the average of five analysts’ estimates compiled by Bloomberg, more than doubling Onyx’s $447 million revenue last year.

“This is an incredibly important step in the company’s growth trajectory,” Michael King, an analyst with Rodman & Renshaw in New York, said in an e-mail. “This is a much better drug than the Street has been giving them credit for.”

The panel’s recommendation, “is an important regulatory milestone,” Ted Love, executive vice president of research and development at Onyx, said yesterday in a statement. “Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review.”

Side Effects

Side effects for the treatment included cardiac arrest, chest pain, pneumonia and shortness of breath, the FDA staff said. More than 70 percent of patients had lung complications with the drug, according to the FDA report.

Carfilzomib would be used to treat multiple myeloma patients who have first tried Celgene Corp.’s Revlimid and Takeda Pharmaceutical Co. Ltd.’s 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.

Ligand, a drugmaker based in La Jolla, California, had gained 37 percent in the 12 months before Thursday.

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Thursday, 21 June 2012 09:48 AM
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