Enrollment for Medivation Study - Analyst Blog

Medivation, Inc. (MDVN) and partner Astellas Pharma Inc. recently announced that they have finished enrolling patients for a phase III study of their prostate cancer candidate, MDV3100.

The phase III study, AFFIRM, is being conducted in men with castration-resistant prostate cancer who were previously treated with Sanofi-Aventis' (SNY) Taxotere (docetaxel)-based chemotherapy. Enrollment was completed on Nov 15, 2010.

The company received permission from the FDA to move MDV3100 into phase III trials based on positive interim data from a phase I/II program. Top-line results from AFFIRM should be out by 2012. Medivation and partner Astellas also have plans to study MDV3100 in early stage prostate cancer patients, which could represent a very big market for the candidate.

During the third quarter of 2010, the companies initiated a phase III study (PREVAIL) with MDV3100 that will be conducted in men with chemotherapy-naïve castration-resistant prostate cancer. Meanwhile, a head-to-head phase II study between MDV3100 and AstraZeneca's (AZN) Casodex (bicalutamide) and a phase II study in hormone-naïve patients are scheduled to commence early next year.

MDV3100, a novel, triple-acting oral androgen receptor antagonist, is being developed in collaboration with Japanese company, Astellas Pharma. We are positive on the deal which was announced in Oct 2009. In addition to receiving an upfront payment of $110 million, Medivation stands to receive up to $335 million on the achievement of development and regulatory milestones, plus $320 million in commercial milestone payments.

Moreover, Medivation is entitled to receive tiered double-digit royalties on ex-US sales. While all US development and commercialization costs and profits will be shared equally, Astellas will be responsible for the ex-US development and commercialization of the candidate. This agreement is a major positive for Medivation. Not only has it brought in cash, Astellas' strong presence in the urology market should be a major boon once MDV3100 is launched.

Neutral on Medivation

We currently have a Neutral recommendation on Medivation, which is supported by a Zacks #3 Rank (short-term Hold rating). Medivation suffered a major setback earlier this year with its lead pipeline candidate, Dimebon, failing to achieve both its primary and secondary endpoints in a phase III study. The results were a huge disappointment for the company and sent the share price plunging.

Although Medivation is continuing with the development of the candidate, we remain concerned that additional development setbacks would have a major impact on the stock. Moreover, we are concerned about partner Pfizer's (PFE) commitment towards the Dimebon collaboration.

 
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