-----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, TC3NjhwRmM3WMhf4gfLmtwXd7hR3AyCHkMdl5qFbd/l8sNqnAxmZPN5zxcT3jP2D LOHJKpqe6qF9drdOfLFh0w== 0001193125-06-109125.txt : 20060511 0001193125-06-109125.hdr.sgml : 20060511 20060511163349 ACCESSION NUMBER: 0001193125-06-109125 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060510 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060511 DATE AS OF CHANGE: 20060511 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: 06830543 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

May 10, 2006

(Date of earliest event reported)

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)

501 Second Street, Suite 211

San Francisco, CA 94107

(Former name or former address, if changed since last report)

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 May 10, 2006, 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 May 10, 2006.


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: May 11, 2006

   

By:

 

/s/ C. Patrick Machado

       

C. Patrick Machado

Senior Vice President and

Chief Financial Officer

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

 

Contacts:

 

Medivation, Inc.

 

Lippert/Heilshorn & Associates

Patrick Machado, Chief Financial Officer

 

Bruce Voss/Don Markley

(415) 543-3470 x201

 

(310) 691-7100

MEDIVATION PROVIDES UPDATE ON HUNTINGTON’S DISEASE IND

SAN FRANCISCO (May 10, 2006) – Medivation, Inc. (AMEX: MDV) today announced that on May 8, 2006 it received a letter from the U.S. Food and Drug Administration (FDA) regarding its investigational new drug (IND) application to begin human testing of Dimebon for Huntington’s disease. The letter confirmed the information initially communicated by the FDA in a February 28, 2006 telephone call that additional rat toxicology data are required before human clinical trials can begin. The FDA expressed the concern that the dose levels of Dimebon used in one of Medivation’s rat toxicology studies did not result in sufficient toxicity to define a maximum tolerated dose. This information might provide additional guidance to physicians regarding the potential toxicities of Dimebon in humans.

To address the FDA’s concern, in March 2006 Medivation initiated additional rat toxicology studies to evaluate Dimebon at higher doses than those used in the prior study. Medivation expects to have sufficient data in the third quarter of 2006 to request the FDA to allow initiation of the proposed Phase 1-2a clinical study of Dimebon in patients with Huntington’s disease.

About Medivation

Medivation, Inc. acquires promising pharmaceutical and medical device technologies in the late preclinical development phase, and develops those technologies quickly and cost-effectively through human first proof-of-efficacy studies (generally the end of Phase 2 clinical trials). Depending on the indication, Medivation will either seek to sell or partner successful programs with larger pharmaceutical, biotechnology and medical device companies for late-stage clinical studies and commercialization, or alternatively conduct those activities internally. The Company intends to build and maintain a portfolio of 4 to 6 development programs at all times.

Medivation’s current portfolio consists of small molecule drugs in development to treat 3 large, unmet medical needs – Alzheimer’s disease, Huntington’s disease and hormone-refractory prostate cancer, the last two of which are likely Orphan Drug indications. Dimebon™, with a 20-year record of human use and demonstrated efficacy in animal studies of both Alzheimer’s disease (AD) and Huntington’s disease (HD) and in a pilot clinical study of AD, is in a randomized, double-blind, placebo-controlled Phase 2 study in AD patients in Russia, the results of which are expected to be available in Q3 2006. Medivation also expects to initiate a Phase 1-2a study of Dimebon in HD patients in 2006, and a Phase 1-2a study of


the lead MDV300 series compound in hormone-refractory prostate cancer patients in the first half of 2007. Further information about Medivation can be found on its website (www.medivation.com).

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding the anticipated timing of regulatory and clinical milestones on the Company’s Alzheimer’s disease, Huntington’s disease and hormone-refractory prostate cancer programs, 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. Our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-KSB for the year ended December 31, 2005, include more information about factors that could affect our financial and operating results.

# # #

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