-----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, Ps/1wBPxPts/Sbu9tAxA8FIehQT2rjDyzy1oPamla5wCUL6cMKGCE0o0c+ATZXag LylhW4Yi/KVq6F1BiBjWqg== 0001193125-07-148366.txt : 20070702 0001193125-07-148366.hdr.sgml : 20070702 20070702165049 ACCESSION NUMBER: 0001193125-07-148366 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20070614 ITEM INFORMATION: Other Events FILED AS OF DATE: 20070702 DATE AS OF CHANGE: 20070702 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: 07956001 BUSINESS ADDRESS: STREET 1: 501 SECOND STREET STREET 2: SUITE 211 CITY: SAN FRANCISCO STATE: CA ZIP: 94107 BUSINESS PHONE: 415-543-3470 MAIL ADDRESS: STREET 1: 501 SECOND STREET STREET 2: SUITE 211 CITY: SAN FRANCISCO STATE: CA ZIP: 94107 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) June 14, 2007

 

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.)

55 Hawthorne Street, Suite 610 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 June 14, 2007 we received notification from the U.S. Food and Drug Administration (FDA) that we may proceed with our Phase 2 randomized, double-blind, placebo-controlled study of three-months of Dimebon treatment in patients with Huntington’s disease. The Phase 1 portion of the study already has been completed. The FDA also allowed us to increase enrollment by 20% to 90 patients in the Phase 2 portion of this study, while we previously had expected to enroll only 75 patients. We expect to enroll the first Phase 2 patient in July 2007. Based upon the anticipated start date and the increased number of patients to be enrolled in the Phase 2 study, we now expect to report study data in the first half of 2008. We continue to expect that Phase 3 studies in Huntington’s disease will begin in 2008 if the Phase 2 study results are supportive.

On June 29, 2007, we received clearance from the FDA to begin our Phase 1-2a clinical trial of MDV3100 in patients with hormone-refractory prostate cancer. We expect to enroll the first patient in July 2007 and remain on target to report data from the first subset of patients in this trial in the second half of 2007.

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.

 

    MEDIVATION, INC.
Dated: July 2, 2007   By:  

/s/ C. Patrick Machado

    C. Patrick Machado
    Senior Vice President and Chief Financial Officer
 -----END PRIVACY-ENHANCED MESSAGE-----