Medivation, Inc. (MDVN) and partner, Astellas Pharma Inc., received a major boost with the US Food and Drug Administration (FDA) granting approval for their prostate cancer candidate, Xtandi (enzalutamide).
The FDA approved Xtandi for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. Approval came well ahead of the Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012.
Per the requirements of the FDA, Medivation and Astellas have agreed to conduct an open label safety study of Xtandi at the approved dose of 160 mg per day in patients who are at high risk for seizure. The companies have agreed to provide results from this study, which will involve about 350 patients, in 2019. We note that the “warnings and precautions” section of the product label mentions that about 0.9% of patients in the Xtandi arm experienced a seizure compared to none in the placebo arm of a randomized study.
Meanwhile, Medivation also announced that its marketing application for Xtandi in the EU has been accepted for review. With the FDA approval of Xtandi and the acceptance of the EU filing, Medivation stands to receive total milestone payments of $35 million from Astellas. About 10% of these milestone payments will be paid to UCLA as per the terms of Medivation’s licensing agreement with UCLA.
Xtandi could very well be a game-changer for Medivation. The prostate cancer market represents huge commercial potential. According to the American Cancer Society, prostate cancer is the most commonly diagnosed cancer among men in the US, other than skin cancer. It is estimated by the American Cancer Society that about 241,740 new cases of prostate cancer will be diagnosed in the US in 2012 with 28,170 men expected to die from the disease.
Medivation and Astellas expect to launch Xtandi in mid-September at a wholesale acquisition cost of $7,450 for a 30-day supply. While Medivation has a 60-person sales force in place for promoting Xtandi, Astellas will be using a 90-person sales force to promote the product.
Currently approved prostate cancer treatments include Sanofi’s (SNY) Jevtana and Johnson and Johnson’s (JNJ) Zytiga among others.
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