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Johnson & Johnson Prostate Cancer Drug Approved by U.S. FDA

Johnson & Johnson’s abiraterone acetate, a pill to be marketed as Zytiga, was approved by U.S. regulators for use in patients with late-stage prostate cancer who had previously received chemotherapy.

The drug targets a protein to reduce levels of testosterone, a male hormone that fuels prostate cancer growth, the Food and Drug Administration said today in a statement on its website announcing the approval.

The drug may generate sales of $800 million by 2015, Larry Biegelsen, an analyst at Wells Fargo & Co., said today in a note to clients. Along with treatments being developed for hepatitis C, strokes and AIDS, J&J may launch four drugs this year that may boost profits above the company’s estimates, he said. J&J predicted earnings of $4.90 a share to $5 a share on April 19.

Insurers’ payments for abiraterone “will be fairly broad given the limited available treatment options and the reasonable pricing, which could lead to upside to J&J’s conservative 2011 guidance,” Biegelsen said.

J&J is likely to sell the drug for an average wholesale price of $5,000 a month, with typical treatments lasting eight months, he said.

An FDA advisory panel today also voted to recommend marketing clearance for telaprevir, the hepatitis drug whose rights are shared by J&J and Vertex Pharmaceuticals Inc. of Cambridge, Massachusetts. The medicine works sufficiently to outweigh risks of skin rash and anemia, the advisers said at a hearing in Silver Spring, Maryland.

Cougar Purchase

J&J fell 19 cents to $65.38 at 4:02 p.m. in New York Stock Exchange composite trading. The shares have gained 1.2 percent in the past 12 months.

The prostate treatment, approved two months ahead of its scheduled FDA decision date, was acquired in J&J’s $878 million purchase of Cougar Biotechnology in July 2009.

It will compete with Dendreon Corp.’s Provenge, an immune therapy for late-stage prostate cancer that may have annual sales of $2 billion in 2014, according to the average estimate of five analysts surveyed by Bloomberg.

“Zytiga prolonged the lives of men with late-stage prostate cancer who had received prior treatments and had few available therapeutic options,” Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.

In a study, 1,195 patients with advanced prostate cancer patients who received abiraterone, along with the steroid prednisone, lived a median of 3.9 months longer than those treated with prednisone alone, according to company-sponsored findings presented Oct. 11 at the European Society for Medical Oncology meeting in Milan.

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