SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 10, 2010
(Exact name of registrant as specified in its charter)
201 Spear Street, 3rd Floor
San Francisco, California 94105
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (415) 543-3470
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Item 8.01 Other Events.
On September 9, 2010, a unit of Johnson and Johnson publicly disclosed that in a pre-specified interim analysis its investigational drug abiraterone acetate improved overall survival in a Phase 3 trial of patients with castration-resistant prostate cancer who had previously failed chemotherapy. The Johnson and Johnson unit also publicly disclosed its intent to make abiraterone acetate available under an expanded access program prior to receipt of marketing approval. The patient population studied in the abiraterone acetate trial is the same patient population being studied in the ongoing Phase 3 AFFIRM trial of the investigational drug MDV3100 being conducted by Medivation and its partner Astellas. Questions have arisen regarding the potential impact of the abiraterone acetate expanded access program on the ongoing AFFIRM trial, including the question whether patients in the AFFIRM trial may elect to leave the trial to begin treatment with abiraterone acetate. Medivation has been aware of the abiraterone acetate development program since before initiating the AFFIRM trial, and has designed and conducted that trial on the assumption that the abiraterone acetate data would be positive. Medivation has specific measures in place to mitigate any potential impact of the abiraterone acetate data on the ongoing AFFIRM trial. However, for competitive reasons, Medivation will not be discussing publicly what those specific measures are. Medivation expects to complete enrollment in the AFFIRM trial by the end of this year.
This report contains forward-looking statements, including statements regarding the clinical development of Medivations MDV3100 product candidate, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivations actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivations clinical trials, including the risk that adverse clinical trial results could alone or together with other factors result in the delay or discontinuation of some or all of Medivations product development activities, enrollment of patients in Medivations clinical trials, partnering of Medivations product candidates, including Medivations dependence on the efforts of and funding by Astellas for the development of MDV3100, the achievement of development, regulatory and commercial milestones under Medivations collaboration agreements, the manufacturing of Medivations product candidates, the adequacy of Medivations financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivations filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended June 30, 2010, filed with the SEC on August 9, 2010. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this report. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this report.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.