Medivation Gets OK; New Competitor for Provenge

Updated as of Sept. 4.

Dendreon has another competitor for its drug Provenge to worry about now that the Food and Drug Administration (FDA) has approved Medivation’s late-stage prostate cancer treatment.

The drug, jointly developed by Medivation and Astellas Phama, is approved to treat men with prostate cancer that has spread or returned after prior treatment with docetaxel. The drug, brand name Xtandi, will be a direct competitor of Dendreon’s Provenge.

"The need for additional treatment options for advanced prostate cancer continues to be important for patients," Richard Pazdur, director of hematology and oncology products at the F.D.A.’s drug evaluation and research center, said in a statement. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life."

Dendreon was down 1.3% for the day, while Medivation was up 1.41% until shares were halted just before the FDA announcement. When trading resumed, the finished out the day up 8%. On Monday at opening bell Medivation stock was up another 4.7% to $109.63, hitting a new 52-week high.

Trading was halted just after 1 p.m. on Friday when the FDA announced the approval and resumed around 3:40 p.m. On Monday, the stock was up 4% at the opening bell.

Medivation’s stock is up 110% on the year. Dendreon is down 39.95%. Dendreon’s Provenge was already struggling with lagging sales because of another competitor: Johnson & Johnson’s Zytiga. JNJ fell slightly at the news of the FDA’s approval, but was still up .22%.

In November, Medivation had reported that Xtandi improved median survival by 4.8 months in a study. The most common side effects with Xtandi were weakness, fatigue and back pain.

"We believe XTANDI has the potential to play an important role in the treatment of advanced prostate cancer," Stephen Eck, M.D., Ph.D., vice president of Medical Oncology, Astellas Pharma Global Development, said in a statement.