Medivation, Inc. (MDVN) and Astellas Pharma, Inc. recently announced the initiation of a phase II study with their prostate cancer candidate, MDV3100. The study will evaluate MDV3100 as a monotherapy in hormone-naïve prostate cancer patients.
The open-label, single-arm study (n=60) is being conducted in Europe. MDV3100 is currently in another phase II (head-to-head) study (TERRAIN), which is comparing MDV3100 with AstraZeneca’s (AZN) Casodex (bicalutamide).
In addition to these two studies, MDV3100 is in two phase III studies – AFFIRM and PREVAIL. The phase III AFFIRM study is being conducted in men with castration-resistant prostate cancer who were previously treated with Sanofi-Aventis’ (SNY) Taxotere (docetaxel)-based chemotherapy.
Medivation received permission from the FDA to move the candidate 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. However, data could be available in 2011 itself if Medivation and Astellas decide to conduct an interim analysis.
The second phase III study (PREVAIL) is being conducted in men with chemotherapy-naïve castration-resistant prostate cancer.
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 major development setbacks with its late-stage pipeline candidate, dimebon, which failed to achieve its primary endpoints in phase III studies for Alzheimer’s and Huntington disease. Given the disappointing track record of dimebon, we are concerned about partner Pfizer’s (PFE) commitment towards the collaboration. With dimebon failing in two phase III studies, we expect investor focus to shift to the development of MDV3100.
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