0001193125-12-005890.txt : 20120109 0001193125-12-005890.hdr.sgml : 20120109 20120109072253 ACCESSION NUMBER: 0001193125-12-005890 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20120109 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120109 DATE AS OF CHANGE: 20120109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDIVATION, INC. CENTRAL INDEX KEY: 0001011835 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133863260 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32836 FILM NUMBER: 12515973 BUSINESS ADDRESS: STREET 1: 201 SPEAR STREET, 3RD FLOOR CITY: SAN FRANCISCO STATE: CA ZIP: 94105 BUSINESS PHONE: 415-543-3470 MAIL ADDRESS: STREET 1: 201 SPEAR STREET, 3RD FLOOR CITY: SAN FRANCISCO STATE: CA ZIP: 94105 FORMER COMPANY: FORMER CONFORMED NAME: ORION ACQUISITION CORP II DATE OF NAME CHANGE: 19960408 8-K 1 d279302d8k.htm FORM 8-K Form 8-K

 

 

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 9, 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)

Registrant’s 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 9, 2012, Medivation, Inc. and Astellas Pharma Inc. issued a joint press release entitled “Data from Phase 3 AFFIRM Trial of MDV3100 in Advanced Prostate Cancer to be Highlighted in Late-Breaking Presentation at ASCO GU.” 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 9, 2012, entitled “Data from Phase 3 AFFIRM Trial of MDV3100 in Advanced Prostate Cancer to be Highlighted in Late-Breaking Presentation at ASCO GU.”

 

-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 9, 2012     By:  

/s/ C. Patrick Machado

      C. Patrick Machado
      Chief Business Officer and Chief Financial Officer


EXHIBIT INDEX

 

99.1    Press release, dated January 9, 2012, entitled “Data from Phase 3 AFFIRM Trial of MDV3100 in Advanced Prostate Cancer to be Highlighted in Late-Breaking Presentation at ASCO GU.”
EX-99.1 2 d279302dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

LOGO    LOGO
Medivation Contacts:    Astellas Contacts:
Patrick Machado    Jenny Kite
Chief Business & Financial Officer    Corporate Communications
(415) 829-4101    (847) 317-5405
Anne Bowdidge    Mike Beyer
Investor Relations    Sam Brown, Inc (media for both companies)
(650) 218-6900    (773) 463-4211

Data from Phase 3 AFFIRM Trial of MDV3100 in Advanced Prostate Cancer to

be Highlighted in Late-Breaking Presentation at ASCO GU

SAN FRANCISCO, CA and TOKYO – January 9, 2012 – Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. today announced that data from the Phase 3 AFFIRM trial, evaluating MDV3100 in men with advanced prostate cancer, will be highlighted in a late-breaking oral presentation at the upcoming American Society of Clinical Oncology 2012 Genitourinary Cancers Symposium in San Francisco, CA.

Details of the oral presentation are as follows:

Title: Effect of MDV3100, an androgen receptor signaling inhibitor (ARSI), on overall survival in patients with prostate cancer postdocetaxel: Results from the phase III AFFIRM study

Presenter: Howard I. Scher, M.D., chief, Genitourinary Oncology Service at Memorial-Sloan Kettering Cancer Center, and the co-principal investigator of the AFFIRM study

 

   

Thursday, February 2 from 10:15-11:45am PT

 

   

General Session II: Castration-Resistant Prostate Cancer — Treatment Sequencing and Implementation

About the AFFIRM Trial

The Phase 3 AFFIRM trial is a randomized, double-blind, placebo-controlled, multinational trial evaluating MDV3100 (160 mg/day) versus placebo in 1,199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy. In November 2011, the Independent Data Monitoring Committee overseeing the AFFIRM trial informed the companies of positive overall survival results from the planned interim analysis and recommended that the study be stopped early and that all patients who received placebo be offered MDV3100. MDV3100 has been granted Fast Track designation by the FDA for the post-chemotherapy indication.

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 partners Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer and mild-to-moderate Alzheimer’s disease. 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 MDV3100. For more information on Astellas Pharma Inc., please visit our website at www.astellas.com/en.

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