0001193125-12-012837.txt : 20120117 0001193125-12-012837.hdr.sgml : 20120116 20120117070753 ACCESSION NUMBER: 0001193125-12-012837 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20120117 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120117 DATE AS OF CHANGE: 20120117 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: 12528080 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 d284122d8k.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 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)

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 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 Alzheimer’s 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 Alzheimer’s 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 Alzheimer’s Disease.”
EX-99.1 2 d284122dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

LOGO   LOGO

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 ALZHEIMER’S 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 Alzheimer’s disease. Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog), which measures cognitive ability, or the Alzheimer’s 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 Alzheimer’s 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 Alzheimer’s 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 Alzheimer’s 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 Alzheimer’s 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 Alzheimer’s 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 world’s 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 world’s 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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