Medivation Emerges With New Prostate Cancer Drug

5/31/12Follow @xconomy

San Francisco-based Medivation doesn’t quite have the brand name recognition of its rivals in the world of prostate cancer drug development, but that could be starting to change, as soon as this weekend.

Medivation (NASDAQ: MDVN) has been on a big-time roll since November, when it released results from a study of 1,200 patients, called Affirm, that showed an experimental drug could extend the lives of men with terminal prostate cancer for a median time of 4.8 months compared with a placebo. Six months later, the drug is still generating buzz heading into this weekend’s big cancer drug confab, the American Society of Clinical Oncology. Investors can’t seem to get enough, as the stock has been on a truly spectacular run, climbing from a low of $14.32 in the past year to close at $85.01 a share yesterday.

While Medivation doesn’t have another earthshaking news update to provide on its drug at ASCO, it’s clear that this pill, and what it can do for prostate cancer patients, will be one of the hot topics of conversation at the big cancer meeting in Chicago. The burning question is whether Medivation and its partner Astellas Pharma can build on the early momentum, by winning FDA approval for its product enzalutamide (MDV3100), and whether it can show its drug also works for a larger group of prostate cancer patients with a less advanced form of the disease. If Medivation can do that—and most analysts are betting it will—then it will truly be on a collision course against marketed drugs from Seattle-based Dendreon (NASDAQ: DNDN) and New Brunswick, NJ-based Johnson & Johnson (NYSE: JNJ) that have shown an ability to prolong lives in the past couple of years.

Johann de Bono

Even though there is a lively ongoing debate about how aggressively to screen for prostate cancer, and whether widespread medical interventions cause more harm than good for this slow-moving malignancy, analysts still see a multi-billion dollar market emerging. About 30,000 men in the U.S. die from prostate cancer each year, according to the American Cancer Society.

“There’s an urgent need for more patients to get an improved outcome. For 50 years we had very little progress, and in the last five years, we’ve had five new agents that improve survival,” says Johann de Bono, a professor at the Institute of Cancer Research in London, and the lead investigator of the 1,200-patient study, which Medivation called Affirm. The Medivation drug is a particular standout, he says, because at least in the Affirm study, “these patients are dying but at least they are living longer, with better quality of life. These were patients with only months left to live. These results were particularly impressive because of that.”

Even though most of the key details on the Affirm study were released at a smaller ASCO conference in February, physicians were still buzzing about it earlier this month at the American Urological Association meeting in Atlanta. The study enrolled patients whose prostate cancer had spread, and no longer responded to traditional chemical castration therapies that shut off the supply of male hormones that help fuel tumor growth. The patients had also previously gotten docetaxel (Taxotere) chemotherapy, often considered the last-ditch therapy.

Despite how sick those patients were, the Medivation drug passed the study with flying colors. Patients lived a median time of 18.4 months on the drug, compared with 13.6 months on a placebo. Medivation’s product also showed it could reduce prostate-specific antigen (PSA) scores by at least half for most patients (54 percent) while that only happened for 1.5 percent of placebo patients. The drug kept tumors from spreading for 8.3 months compared with 3 months for the placebo. Medivation’s product also met the criteria for quality of life improvement in 43 percent of patients, compared with about 18 percent of the patients on placebo. All of those findings were statistically significant, meaning there’s little chance the results were a fluke.

“There is no doubt that enzalutamide (MDV3100) is the next big thing in urology,” said David Miller, president of Biotech Stock Research, in a note to clients May 22 at the end of the AUA conference. “No other drug we see comes close.”

Each of the new drugs for prostate cancer is designed … Next Page »

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