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): August 3, 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.) |
525 Market Street, 36th Floor
San Francisco, California 94105
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (415) 543-3470
(Former name or former address, if changed since last report)
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 August 3, 2012, Medivation, Inc. and Astellas Pharma Inc. issued a joint press release entitled Medivation and Astellas Announce PDUFA Action Date for Enzalutamide NDA. 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 August 3, 2012, entitled Medivation and Astellas Announce PDUFA Action Date for Enzalutamide NDA. |
-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: August 3, 2012 | By: | /s/ C. Patrick Machado | ||
C. Patrick Machado | ||||
Chief Business Officer and Chief Financial Officer |
EXHIBIT INDEX
99.1 | Press release, dated August 3, 2012, entitled Medivation and Astellas Announce PDUFA Action Date for Enzalutamide NDA. |
Exhibit 99.1
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Medivation Contacts: | Astellas Contacts: | |
Patrick Machado | Jenny Kite | |
Chief Business & Financial Officer | Corporate Communications | |
(415) 829-4101 | (847) 682-4530 | |
Anne Bowdidge | Mike Beyer | |
Senior Director, Investor Relations | Sam Brown, Inc (media for both companies) | |
(650) 218-6900 | (773) 463-4211 |
Medivation and Astellas Announce PDUFA Action Date for Enzalutamide NDA
San Francisco, CA and Tokyo August 3, 2012 Medivation, Inc. (Nasdaq: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012 for the review of the investigational agent enzalutamide (formerly MDV3100) New Drug Application (NDA) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy. The companies announced on July 24, 2012 that the FDA accepted the enzalutamide NDA filing for review and granted Priority Review Designation.
About Enzalutamide
Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. Enzalutamide inhibits androgen receptor signaling in three distinct ways: it inhibits 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors.
In the Phase 3 AFFIRM trial common side effects observed more frequently in enzalutamide as compared with placebo-treated patients included fatigue, diarrhea and hot flush. Seizure was reported in less than 1% of enzalutamide-treated patients. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the enzalutamide group than in the placebo group.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel therapies 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 families. For more information, please visit us at www.medivation.com.
About Astellas Pharma Inc.
Astellas Pharma Inc. is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. The organization is committed to becoming a global category leader in oncology, and has several oncology compounds in development in addition to enzalutamide. For more information on Astellas Pharma Inc., please visit our website at www.astellas.com/en.