Medivation’s Prostate Cancer Drug Approved by U.S. FDA

Medivation Inc., a biotechnology company whose shares have jumped sixfold in the past 12 months, won approval from U.S. regulators for a late-stage prostate cancer treatment.

The drug, to be sold under the name Xtandi, was developed with Tokyo-based Astellas Pharma Inc., and the companies will split sales. The approval may increase San Francisco-based Medivation’s sales to $357 million in 2013 from $60 million last year, according to data compiled by Bloomberg.

Medivation’s therapy, approved three months before the scheduled decision date, is designed for patients whose cancer has advanced beyond the prostate even with previous treatments, the Food and Drug Administration said today in a statement. Xtandi extended patients’ survival to 18.4 months, compared with 13.6 months for those on a placebo in a clinical trial.

“The need for additional treatment options for advanced prostate cancer continues to be important for patients,” Richard Pazdur, the FDA director of the Office of Hematology and Oncology Products, said in the statement. “Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life.”

Medivation’s Xtandi will compete with Johnson & Johnson’s Zytiga and Dendreon Corp.’s Provenge. Medivation plans to start selling the drug in mid-September, Chief Executive Officer David Hung said. Zytiga generated $432 million in the first six months of this year. Sales of Provenge were $162 million.

Treatment Cost

Medivation will join with Astellas’s U.S. sales force, and the medicine will cost $7,450 for a 30-day supply, Hung said today on a conference call. Patients in the clinical trial used the drug for eight months. Hung called it “an historic day” for the company.

Fifteen percent of the 241,000 American men a year who are diagnosed with prostate cancer see it spread beyond the walnut-sized gland, according to the National Cancer Institute.

Medivation’s “cancer drug to me looks to be the best drug so far for prostate cancer, which is a big category, a big market,” Howard Liang, a Boston-based analyst for Leerink Swann LLC, said last month in a telephone interview. “It’s not common for a mid-cap company to be associated with a product that’s best in class for a big category.”

Medivation gained 7.6 percent to $104.86 at 4 p.m. New York time, its highest closing price since the shares began trading in 1996. The company announced Aug. 28 that it plans a two-for-one stock split on Sept. 21.

The drug has also been submitted to the European Medicines Agency, Europe’s drug regulatory body, Medivation said in a statement. The EMA submission triggers a $5 million milestone payment from Astellas, in addition to a $30 million payment for the FDA approval.

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