-----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, KUYY8h4Gg6uAGTTg6KSVrJH+1tmUUCzLAHc961gDVkown9/Ym/GZnksr0c/RrK/V 0Doz+15gApSHIMwJ9Pc1CQ== 0001193125-08-012823.txt : 20080128 0001193125-08-012823.hdr.sgml : 20080128 20080128081539 ACCESSION NUMBER: 0001193125-08-012823 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080128 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080128 DATE AS OF CHANGE: 20080128 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: 08552403 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

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 28, 2008

MEDIVATION, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-32836   13-3863260

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

201 Spear Street, 3rd Floor

San Francisco, CA 94105

(Address of principal executive offices) (Zip Code)

(415) 543-3470

(Registrant’s telephone number, including area code)

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 8.01. Other Events.

On January 28, 2008, Medivation, Inc. issued a press release, a copy of which is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

99.1    Press Release dated January 28, 2008.


SIGNATURES

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.

Dated: January 28, 2008

 

MEDIVATION, INC.
By:   /s/ C. Patrick Machado
Name:   C. Patrick Machado
Title:   Senior Vice President & Chief Financial Officer


EXHIBIT INDEX

 

99.1    Press Release dated January 28, 2008.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

 

Contacts:  
Medivation, Inc.   WeissComm Partners
Patrick Machado, Chief Financial Officer   Jani Bergan
(415) 829-4101   (415) 946-1064

MEDIVATION PLANS TO INITIATE PIVOTAL CONFIRMATORY PHASE 3 TRIAL OF

DIMEBON FOR ALZHEIMER’S DISEASE IN SECOND QUARTER OF 2008

— Conference Call Today at 4:30 p.m. Eastern Time —

SAN FRANCISCO (January 28, 2008) – Medivation, Inc. (NASDAQ: MDVN) today announced that, based on its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company plans to begin a pivotal confirmatory Phase 3 trial of Dimebon for mild-to-moderate Alzheimer’s Disease in the second quarter of 2008.

The FDA informed Medivation that the company’s previously completed trial conducted in Russia can be used as one of the two pivotal studies required to support the approval of Dimebon to treat mild-to-moderate Alzheimer’s disease, as long as a significant proportion of the sites in the confirmatory Phase 3 trial are located in the United States.

“We are now a Phase 3 company with clear regulatory guidance on the pivotal trials required to seek marketing approval for Dimebon in the United States,” said David T. Hung, M.D., president and chief executive officer of Medivation. “This is a significant step forward for Medivation, and validates our strategy to advance Dimebon directly into a pivotal Phase 3 trial.”

The Phase 3 clinical trial will enroll approximately 525 patients with mild-to-moderate Alzheimer’s disease at sites in the United States, Europe and South America. Patients will be randomized to one of three treatment groups: Dimebon 20 mg three times per day (TID); Dimebon 5 mg TID; and placebo. Patients will be treated for six months and may not be taking any other Alzheimer’s disease drugs. The primary endpoints are the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Clinician’s Interview-Based Impression of Change plus caregiver interview (CIBIC-plus).

In the previously completed trial Dimebon-treated patients were significantly improved over placebo patients on both the ADAS-cog and CIBIC-plus, with p values of less than 0.0001. This level of statistical significance is several times better than what is required to obtain marketing approval.

“We changed as little as possible in the design of the Phase 3 trial given the highly statistically significant results of our previous trial,” said Lynn Seely, M.D., chief medical officer of Medivation. “The primary endpoints, duration of treatment and patient inclusion and exclusion criteria are all substantially identical to the previous trial. The primary differences are that the Phase 3 trial will be global and will test two doses of Dimebon – the dose studied in the previous trial plus a lower dose to address the regulatory recommendation that minimum effective dose be explored in the development of investigational drugs.”


Medivation expects to complete the pivotal confirmatory Phase 3 trial and apply for marketing approval in 2010.

Conference Call Details

To access the live conference call today at 4:30 p.m. Eastern Time via phone, please dial 877-627-6590 from the United States and Canada or +1-719-325-4868 internationally. Please dial in approximately 10 minutes prior to the start of the call. Individuals interested in listening to the live call via webcast may do so by visiting www.medivation.com and clicking on the “Investor Relations” section. A replay of the webcast will be available on the Company’s website for 30 days.

About Medivation

Medivation, Inc. is a biopharmaceutical company with small molecule drugs in clinical development to treat three large, unmet medical needs – Alzheimer’s disease, Huntington’s disease and hormone-refractory prostate cancer. For more information, please go to www.medivation.com.

This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties that could cause actual results to differ significantly from those projected. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. None of the Company’s product candidates has been approved for sale, significant additional animal and human testing is required in order to seek marketing approval for any of its product candidates, and Medivation cannot assure you that marketing approval can be obtained for any of its product candidates. Furthermore, as is typically the case at this stage of the regulatory review process, the FDA has not yet performed an in-depth review of Medivation’s preclinical and clinical data, so its views remain subject to change. Medivation’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2006, include information about additional factors that could affect the Company’s financial and operating results.

# # #

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