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Medivation Prostate Cancer Drug Works Well, Appears Safe in Study


The next step for CEO David Hung is to apply for US approval of his experimental treatment.

Signs are pointing positive for Medivation's (MDVN) experimental prostate cancer pill, a potential blockbuster if it can win US approval.

According to a briefing by researchers from Memorial Sloan-Kettering Cancer Center, the company's drug appears to be effective and generally safe. On Thursday, researcher Dr. Howard Scher will present study data at a meeting in San Francisco.

"Looking at the totality of the data, I think this drug has an attractive profile," Medivation CEO David Hung says in an interview. "The data speaks for itself."

Medivation is studying the drug in the last of three phases of study generally needed for US approval. The company is expected to apply for US Food and Drug Administration approval soon.

If approved, Medivation would compete with Johnson & Johnson's (JNJ) Zytiga, which was approved in the US last year, and Dendreon's (DNDN) vaccine Provenge to treat men in the advanced stages of prostate cancer. Medivation, which is developing its drug with partner Astellas of Japan, hopes to sell what would be the first in a new class of drugs known as androgen receptor signaling inhibitors. It's aimed at treating men who have already received chemotherapy.

"MDV3100 not only has the best efficacy profile but also the best safety profile" among drugs for patients in late stages of the disease, William Blair analyst Katherine Xu says in a note.

Hung says company studies that the drug is safe. A small number of patients taking Medivation's drug had seizures during testing. But the percentage is so small -- less than 1% -- it's unlikely to cause serious concern, some analysts say.

In a study of almost 1,200 men with advanced prostate cancer, Medivation's drug was shown to increase survival by more than 18 months, or almost 5 months longer than a placebo. The drug was generally well tolerated by the patients. In November, the company said it stopped the study early because it met its goal. Men who were taking placebos in the study were offered the Medivation drug.

Following the initial report of MDV3100's success in November, the company's stock surged. (See Medivation's Stock Doubles on Prostate Cancer Success.) Shares of Medivation are up almost 300% over the past 12 months, trading Tuesday at $55.41. They are up 15% premarket Wednesday.

Winning approval for treatment of advanced prostate cancer is just the first step for Medivation's drug. The company also is testing the treatment on men who have not yet received chemotherapy, a much larger patient population.

"That's a very, very important unmet need and the largest opportunity for this drug," Hung says.

The company is in late stages of testing the drug for that use but Hung declined to be more specific about the progress of the research.

Twitter: @brettchase

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