-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DGmFLOLMn3sN6RkYnSJMvB3ADKj6e/abRQuCI8wlbUYQgw/rGzvtfkCA93McEffC umAS76OjB8Fm4JblwgPpDg== 0001193125-08-188847.txt : 20080903 0001193125-08-188847.hdr.sgml : 20080903 20080903073117 ACCESSION NUMBER: 0001193125-08-188847 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080829 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080903 DATE AS OF CHANGE: 20080903 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: 081052660 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 d8k.htm FORM 8-K Form 8-K

 

 

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 29, 2008

MEDIVATION, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-32836   13-3863260
(State of jurisdiction)   (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 (see General Instruction A.2. below):

 

¨ 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 1.01 Entry into a Material Definitive Agreement.

On August 29, 2008, Medivation, Inc. (“Medivation”) entered into a Collaboration Agreement with Pfizer Inc. (“Pfizer”), pursuant to which Medivation and Pfizer will develop and commercialize Dimebon, Medivation’s investigational drug for treatment of Alzheimer’s disease and Huntington’s disease. The agreement is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Dimebon currently is being evaluated in an international, confirmatory Phase III trial in patients with mild-to-moderate Alzheimer’s disease. Medivation and Pfizer will collaborate on development of Dimebon for Alzheimer’s disease and Huntington’s disease for the United States market, including associated regulatory filings with the United States Food and Drug Administration. In addition, following FDA approval and launch of Dimebon in the United States, Medivation and Pfizer will co-promote Dimebon to specialty physicians in the United States, and Pfizer will promote Dimebon to primary care physicians in the United States. Pfizer will be responsible for development and seeking regulatory approval for, and commercialization of, Dimebon outside the United States. After a period of transition to Pfizer, it will be responsible for all manufacture of product for both clinical and commercial purposes. Both parties have agreed not to commercialize any product directed to the same primary molecular target as Dimebon for a specified time period, subject to certain exceptions.

The agreement establishes several joint committees consisting of an equal number of representatives from both parties that will operate by consensus to oversee the collaboration. In the event that a joint committee is unable to reach consensus on a particular issue, then depending on the issue, a dispute may be decided at the joint committee level by the party with the final decision on the issue or escalated to senior management of the parties. If a dispute is escalated to senior management and no consensus is reached, then the dispute may be decided by the party with the final decision on such issue. Other issues can only be decided by consensus of the parties, and unless and until the parties’ representatives reach agreement on such issue, no decision on such issue will be made, and the status quo will be maintained.

Medivation will receive an up-front cash payment of $225 million. Medivation also is eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional milestone payments upon the achievement of certain net sales levels for the product. Medivation and Pfizer will share the costs and expenses of developing and commercializing Dimebon for the United States market on a 60%/40% basis, with Pfizer assuming the larger share, and the parties will share profits (or losses) resulting from the commercialization of Dimebon in the United States in such proportions. Outside the United States, Pfizer will bear all development and commercialization costs and will pay Medivation tiered royalties on the aggregate net sales of Dimebon.

Medivation is permitted to terminate the Collaboration Agreement for an uncured material breach by Pfizer. Pfizer has a right to terminate the Collaboration Agreement unilaterally, after 18 months following Dimebon’s first commercial sale, but can earlier terminate at its discretion with advance written notice to Medivation if clinical data for Dimebon

 

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generated after the effective date does not meet certain specified criteria or if regulatory approval is conditioned or delayed. In the event of an uncured material breach of the Collaboration Agreement by Medivation, Pfizer may elect either to terminate the Collaboration Agreement or to keep the Collaboration Agreement in place, but terminate Medivation’s right to participate in development, commercialization (other than co-promoting Dimebon) and other activities for Dimebon, including the joint committees and decision making for Dimebon. However, such termination would not affect Medivation’s financial return or, unless there is an uncured material breach by Medivation of its co-promotion obligations, Medivation’s co-promotion rights. Following any termination of the Collaboration Agreement, all rights to develop and commercialize Dimebon will revert to Medivation, and Pfizer will grant a license to Medivation to enable Medivation to continue such development and commercialization, and will supply product to Medivation during a specified transition period.

A copy of the joint press release issued by the Company and Pfizer, entitled “Pfizer and Medivation Enter Into Global Agreement to Co-Develop and Market Dimebon for the Treatment of Alzheimer’s and Huntington’s Diseases,” announcing the transaction is filed as Exhibit 99.1 hereto and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

99.1    Press release, dated September 3, 2008, entitled “Pfizer and Medivation Enter Into Global Agreement to Co-Develop and Market Dimebon for the Treatment of Alzheimer’s and Huntington’s Diseases.”

 

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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: September 3, 2008     By:   /s/ C. Patrick Machado
      C. Patrick Machado
      Senior Vice President, Chief Financial Officer


EXHIBIT INDEX

 

99.1    Press release, dated September 3, 2008, entitled “Pfizer and Medivation Enter Into Global Agreement to Co-Develop and Market Dimebon for the Treatment of Alzheimer’s and Huntington’s Diseases.”
EX-99.1 2 dex991.htm PRESS RELEASE, DATED SEPTEMBER 3, 2008 Press release, dated September 3, 2008

Exhibit 99.1

 

  Pfizer Contacts:
 

Joan Campion (media)

 

(212) 733-2798

 

Joan.Campion@Pfizer.com

 

Suzanne Harnett (investors)

 

(212) 733-8009

 

Suzanne.Harnett@Pfizer.com

  Medivation Contacts:
 

Patrick Machado

 

(415) 829-4101

 

patrick.machado@medivation.com

 

Daryl Messinger

 

(415) 999-2361

 

dmessinger@wcpglobal.com

PFIZER AND MEDIVATION ENTER INTO GLOBAL AGREEMENT TO CO-

DEVELOP AND MARKET DIMEBON FOR THE TREATMENT OF ALZHEIMER’S

AND HUNTINGTON’S DISEASES

— Medivation to Host Conference Call/Webcast Today at 8:30 a.m. Eastern Time —

NEW YORK, NY and SAN FRANCISCO, CA, September 3 – Pfizer Inc. (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) announced today that they have entered into an agreement to develop and commercialize Dimebon, Medivation’s investigational drug for treatment of Alzheimer’s disease and Huntington’s disease. Dimebon currently is being evaluated in an international, confirmatory Phase III trial in patients with mild-to-moderate Alzheimer’s disease (www.connectionstudy.com).

Under the terms of the agreement, Medivation will receive an up-front cash payment of $225 million. Medivation also is eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional undisclosed commercial milestone payments. Medivation and Pfizer will collaborate on the Phase III program in


Alzheimer’s disease, Huntington’s disease development and regulatory filings in the United States. The companies will share all U.S. development and commercialization expenses along with U.S. profits/losses on a 60 percent/40 percent basis, with Pfizer assuming the larger share of both expenses and profit/losses. In addition, Medivation will co-promote Dimebon to specialty physicians in the U.S.

Pfizer will have responsibility for development, regulatory and commercialization outside the U.S. and will pay Medivation tiered royalties on commercial sales outside of the U.S. The agreement is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. J.P. Morgan served as financial advisor, and Cooley Godward Kronish LLP served as legal advisor, to Medivation on this transaction.

Alzheimer’s disease leads to the death of brain cells and the loss of nerve connections in areas of the brain that govern memory, thinking and behavior. Alzheimer’s disease gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry-out daily activities. No currently marketed Alzheimer’s disease drug appears to stop brain cell death and prevent or restore lost nerve connections.

Dimebon is an orally-available, small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer’s disease and Huntington’s disease, making it a potential treatment for these and other neurodegenerative conditions. Based on preclinical data generated to date, Dimebon appears to improve the function of mitochondria, the energy generators in cells that play a vital role in governing brain cell health, growth and overall function. Dimebon also has been shown to stimulate the outgrowth of nerves from brain cells, or neurites, a process that is believed to play an important role in restoring or generating new brain cell connections.

“With more than 18 million people worldwide suffering from the debilitating and ultimately fatal effects of Alzheimer’s disease, Pfizer has made this devastating illness one of our highest priorities,” said Dr. Martin Mackay, president, Pfizer Global Research and Development. “We are working to develop new medicines that improve memory and halt or significantly slow the disease’s progression. We look forward to collaborating with Medivation to bring Dimebon to patients as rapidly as possible.”


“After a rigorous process that garnered substantial interest, we believe that Pfizer is the ideal partner, sharing our vision for Dimebon and capable of maximizing its potential globally,” said Dr. David Hung, president and chief executive officer of Medivation. “As one of the leaders in Alzheimer’s disease, Pfizer is an optimal partner because of its extensive experience developing new medicines; its marketing and commercialization track record; and, its significant global capability to effectively reach primary care physicians, who today prescribe the vast majority of Alzheimer’s disease medications in the U.S.”

About Dimebon’s Clinical Program

Results from the first pivotal trial of Dimebon in Alzheimer’s disease showed that patients treated with Dimebon experienced statistically significant improvements compared to placebo in key aspects of the disease — memory and thinking, activities of daily living, behavior and overall function. Dimebon’s benefit over placebo continued to increase throughout the 12-month treatment period. At the end of 12 months, Dimebon-treated patients were on average functioning as well or better than they had been at the start of the study on each of 5 clinical endpoints. These results were published in the July 19, 2008 issue of The Lancet, and are noteworthy as untreated Alzheimer’s patients progressively deteriorate over time in these areas.

On July 7, 2008, Medivation announced positive safety and efficacy results from its Phase 2 trial of Dimebon in Huntington’s disease, which was conducted in collaboration with the Huntington Study Group. Dimebon appeared to be well tolerated and showed statistically significant benefit versus placebo in cognition as measured by the Mini-Mental State Examination, a secondary endpoint in the study.

Conference Call Information

Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 877-681-3375 for domestic callers and 1-719-325-4933 for international callers. In addition, this call is being Webcast and can be accessed at Medivation’s website at www.medivation.com.


About Pfizer Inc.

Founded in 1849, Pfizer is the world’s largest research-based pharmaceutical company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. Pfizer also partners with healthcare providers, governments and local communities around the world to expand access to medicines and to provide better quality health care and health system support. For more information visit www.pfizer.com.

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. The Company’s current clinical development program includes a pivotal and confirmatory Phase 3 trial of Dimebon in Alzheimer’s disease and a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer. Medivation recently announced that it plans to continue further development of Dimebon in patients with mild-to-moderate Huntington’s disease based on the positive results seen in its Phase 2 trial. For more information, please visit us at http://www.medivation.com.

Forward Looking Statements

Pfizer Forward Looking Statements: The information contained in this release is as of September 3, 2008. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about an agreement between Pfizer and Medivation to develop and commercialize a product candidate, Dimebon, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for Dimebon as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.


A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and in its reports on Form 10-Q and Form 8-K.

Medivation Forward Looking Statements: This press release contains forward-looking statements, including statements regarding future clinical development plans and milestones, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release 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 Medivation’s actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation’s clinical trials, difficulties or delays in obtaining regulatory approval, enrollment of patients in Medivation’s clinical trials, partnering of Medivation’s product candidates, manufacturing of Medivation’s product candidates, competition with Medivation’s product candidates should they receive marketing approval, the adequacy of Medivation’s financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation’s filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q filed August 11, 2008 with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

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