UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 17, 2012
MEDIVATION, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-32836 | 13-3863260 | ||
(State or other jurisdiction of incorporation) |
(Commission File No.) |
(IRS Employer Identification No.) |
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:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01. | Other Events. |
On January 17, 2012, Medivation, Inc. and Pfizer Inc. issued a joint press release entitled Medivation and Pfizer Announce Results from Phase 3 CONCERT Trial of Dimebon in Alzheimers Disease. A copy of the joint press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits. |
99.1 | Press release, dated January 17, 2012, entitled Medivation and Pfizer Announce Results from Phase 3 CONCERT Trial of Dimebon in Alzheimers Disease. |
-1-
SIGNATURE
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.
MEDIVATION, INC. | ||||
Dated: January 17, 2012 | By: | /s/ C. Patrick Machado | ||
C. Patrick Machado | ||||
Chief Business Officer and Chief Financial Officer |
EXHIBIT INDEX
99.1 | Press release, dated January 17, 2012, entitled Medivation and Pfizer Announce Results from Phase 3 CONCERT Trial of Dimebon in Alzheimers Disease. |
Exhibit 99.1
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Medivation Contacts: Patrick Machado Chief Business & Financial Officer (415) 829-4101
Anne Bowdidge Investor Relations (650) 218-6900 |
Pfizer Contacts: MacKay Jimeson Corporate Media Relations (212) 733-2324
Suzanne Harnett Investor Relations (212) 733-8009 |
MEDIVATION AND PFIZER ANNOUNCE RESULTS FROM PHASE 3 CONCERT TRIAL OF DIMEBON IN ALZHEIMERS DISEASE
Dimebon did not meet primary efficacy endpoints
SAN FRANCISCO, CA and NEW YORK, NY January 17, 2012 Medivation, Inc. (NASDAQ: MDVN) and Pfizer Inc. (NYSE: PFE) today announced results from the CONCERT trial, which is a Phase 3 trial that evaluated dimebon (latrepirdine) when added to ongoing treatment with donepezil HCL tablets in patients with mild-to-moderate Alzheimers disease. Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimers Disease Assessment Scale cognitive subscale (ADAS-cog), which measures cognitive ability, or the Alzheimers Disease Cooperative Study Activities of Daily Living (ADCS-ADL), which measures self care and daily function.
We are disappointed in the CONCERT results and the implications for Alzheimers disease patients and their caregivers, said David Hung, M.D., president and CEO of Medivation. I would like to extend my sincere thanks to the patients, their physicians and study teams involved in this trial.
Dimebon was generally well tolerated in the study. A full analysis of the results from CONCERT will be conducted and submitted for presentation at an upcoming scientific congress.
Medivation and Pfizer will discontinue development of dimebon for all indications and will terminate the ongoing open label extension study in Alzheimers disease. The companies also announce that they will terminate their collaboration to co-develop and market dimebon pursuant to the terms of their Collaboration Agreement.
We recognize Alzheimers is a very complex disease, said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. Despite this disappointing result, Pfizer remains committed to advancing the science of Alzheimers disease, with the ultimate goal of delivering innovative and meaningful new treatment options to patients.
The Phase 3 CONCERT trial was a 12-month global randomized, double-blind, placebo-controlled trial that enrolled 1,003 patients with Alzheimers disease. Patients on a stable dose of donepezil for at least four months were randomized to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times per day or placebo.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. Together with its corporate partner Astellas, Medivation currently has its investigational drug MDV3100 in Phase 3 development to treat advanced prostate cancer. For more information, please visit us at www.medivation.com.
Pfizer Inc.: Working together for a healthier world
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the worlds best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the worlds leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at Pfizer.com.
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