MDV3100 in New Phase III Study - Analyst Blog

Medivation, Inc. (MDVN) and Astellas Pharma recently moved their prostate cancer candidate, MDV3100, into another phase III study. The company initiated a phase III trial (PREVAIL) that will evaluate MDV3100 in advanced prostate cancer patients who are yet to receive chemotherapy.

The randomized, placebo-controlled, double-blind, multi-national trial will enroll approximately 1,700 patients across the United States , Canada , Europe, Australia and Israel . The study has two primary endpoints: overall survival and progression-free survival. Secondary endpoints include time to first skeletal-related event and time to initiation of cytotoxic chemotherapy.

MDV3100 is an investigational therapy in clinical development for the treatment of advanced prostate cancer. The candidate is currently in another phase III trial, AFFIRM, that is evaluating MDV3100 in advanced prostate cancer patients who were previously treated with Sanofi-Aventis’ (SNY) Taxotere (docetaxel)-based chemotherapy. Medivation expects to finish enrolling patients for the AFFIRM study by year-end. Top-line results should be out by 2012.

Preclinical studies have demonstrated that MDV3100 provides more complete suppression of the androgen receptor pathway compared to AstraZeneca’s (AZN) Casodex (bicalutamide), the most commonly used anti-androgen.

Medivation has an agreement with Japanese company, Astellas Pharma, for the development and commercialization of MDV3100 for the treatment of prostate cancer. Medivation stands to receive a milestone payment for the initiation of the latest phase III study, PREVAIL.

The prostate cancer market represents significant commercial potential for the company and the successful development of MDV3100 for the treatment of early-stage prostate cancer patients would be a major boost. According to the company, prostate cancer is the most commonly diagnosed cancer among men in the United States , other than skin cancer.

Neutral on Medivation

We currently have a Neutral recommendation on Medivation, which is supported by a Zacks #3 Rank (short-term “Hold” rating). The company 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. 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.

Meanwhile, we are positive on the company’s collaboration agreement with Astellas for MDV3100. Not only has this agreement brought in cash, Astellas’ strong presence in the urology market should be a major boon once MDV3100 is launched.