We recently reiterated our Neutral recommendation on biopharmaceutical company Medivation Inc. (MDVN). Medivation, which currently does not have any marketed product in its portfolio, focuses on the development of novel small molecule drugs for the treatment of serious diseases for which there are limited treatment options.
Medivation currently has two candidates in its pipeline – dimebon (latrepirdine), which is being developed for the treatment of Alzheimer's disease, and MDV3100, which is being developed for the treatment of castration-resistant prostate cancer. While dimebon is partnered with Pfizer Inc. (PFE), the prostate cancer program is partnered with Astellas Pharma. Both dimebon and MDV3100 are in phase III development.
However, Medivation suffered major development setbacks with dimebon, which failed to achieve its primary endpoints in phase III studies for Alzheimer’s and Huntington disease. The results were a huge disappointment for the company. Although dimebon is in a phase III study (CONCERT) for mild to moderate Alzheimer’s disease, we have low expectations from this study.
Moreover, we are concerned that partner Pfizer could opt out from the dimebon collaboration. We note that Pfizer already has another Alzheimer’s candidate, bapineuzumab, in its portfolio that is being developed with Johnson & Johnson (JNJ). Considering the development setbacks with dimebon, Pfizer could decide to focus its efforts towards the development of bapineuzumab.
Meanwhile, MDV3100 is currently in several studies including a phase III study (AFFIRM) in men with castration-resistant prostate cancer who were previously treated with Sanofi-Aventis’ (SNY) Taxotere (docetaxel)-based chemotherapy. An interim analysis is scheduled for 2011. We expect investor focus to remain on the interim analysis.
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