Friday, November 4, 2011

Medivation Shares More Than Double on Prostate Cancer Drug Trial Data

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By Elizabeth Lopatto - Nov 4, 2011 3:05 AM GMT+0700

Medivation Inc. (MDVN), a company that acquires early-development drugs, more than doubled after its prostate cancer medicine proved so effective that it halted a clinical trial and gave the medicine to all participants.

Medivation rose $23.22 to $39.75 at 4:00 p.m. New York time, in the biggest percentage increase since April 2004.

The trial of the medicine, called MDV3100, was in the final stage of clinical development generally needed for U.S. marketing approval. An interim analysis showed that patients on the medicine lived 4.8 months longer than those on a placebo, according to a statement today from Medivation, based in San Francisco, and its partner, Tokyo-based Astellas Pharma Inc.

“There was a lot of anxiety about the event, so most of the investors who typically own companies like this weren’t involved,” said Geoff Porges, an analyst at Sanford C Bernstein in New York, in a telephone interview. “So now there’s a buying spree as people realize this is a real company.”

Full results will be presented at a future scientific conference, the companies said.

The drugmakers will meet with the U.S. Food and Drug Administration in “early 2012” and will update timelines on regulatory submission after that, according to the statement. Porges expects the drug to come to market in 2013, he said.

241,000 Patients

About 241,000 men will be diagnosed with prostate cancer this year, and 33,700 will die, according to the National Cancer Institute. About 1 man in 6 will be diagnosed with the cancer in his lifetime, according to the American Cancer Society.

MDV3100 was discovered at the University of California, Los Angeles. The therapy, the subject of several ongoing trials, works by suppressing the male hormones that fuel cancer, and does so more completely than AstraZeneca’s Casodex, according to data published in the journal Science in April, 2009.

The latest data, from a trial called Affirm, is meant to treat men who previously received chemotherapy. Another study, dubbed Prevail, is also in the final stage of testing, and is for men who have not yet received chemotherapy.

A phase 2 trial, called Terrain, is enrolling men whose cancer has worsened following surgical castration. Another is evaluating the drug in patients who have not received hormones for prostate cancer treatment.

“We’re very excited because of the survival benefit,” said David Hung, chief executive officer of Medivation, in a telephone interview. “18 months ago, once a man with prostate cancer failed chemo, he went to hospice. Now these men will have another treatment option.”

To contact the reporter on this story: Elizabeth Lopatto in New York at

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

taken from : China Daily

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