0001171843-12-001910.txt : 20120516 0001171843-12-001910.hdr.sgml : 20120516 20120516160415 ACCESSION NUMBER: 0001171843-12-001910 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20120516 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120516 DATE AS OF CHANGE: 20120516 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPROS THERAPEUTICS INC. CENTRAL INDEX KEY: 0000897075 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 760233274 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-15281 FILM NUMBER: 12848854 BUSINESS ADDRESS: STREET 1: 2408 TIMBERLOCH PL STREET 2: SUITE B-7 CITY: WOODLANDS STATE: TX ZIP: 77380 BUSINESS PHONE: 2817193400 MAIL ADDRESS: STREET 1: 2408 TIMBERLOCH PLACE B-7 CITY: THE WOODLANDS STATE: TX ZIP: 77380 FORMER COMPANY: FORMER CONFORMED NAME: REPROS THERAPEUTICS INC DATE OF NAME CHANGE: 20060503 FORMER COMPANY: FORMER CONFORMED NAME: ZONAGEN INC DATE OF NAME CHANGE: 19930208 8-K 1 document.htm FORM 8-K FILING DOCUMENT Form 8-K Filing

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) May 16, 2012 


Repros Therapeutics Inc.
(Exact name of registrant as specified in its charter)


Delaware

001-15281

76-0233274
(State or other jurisdiction
of incorporation)
(Commission File Number) (IRS Employer Identification No.)



2408 Timberloch Place, Suite B-7
The Woodlands, Texas

77380
(Address of principal executive offices) (Zip Code)

Registrant's telephone number, including area code:   (281) 719-3400



________________________________________________________________________________
(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 16, 2012 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

    Exhibit 99.1.       Press release dated May 16, 2012


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.

    Repros Therapeutics Inc.
(Registrant)


May 16, 2012
(Date)
  /s/   JOSEPH PODOLSKI
Joseph Podolski
President and CEO


  Exhibit Index
  99.1 Press release dated May 16, 2012






EX-99 2 newsrelease.htm PRESS RELEASE FDA Receives Repros' Submission for Special Protocol Assessment Documentation for Pivotal Studies for Androxal(R)

EXHIBIT 99.1

FDA Receives Repros' Submission for Special Protocol Assessment Documentation for Pivotal Studies for Androxal(R)

  • Submission starts 45 day PDUFA response clock for FDA comments
  • Expecting to commence screening subjects for open label study

THE WOODLANDS, Texas, May 16, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced it has received confirmation of delivery of the required documentation for Special Protocol Assessment ("SPA") of its Androxal® Phase 3 pivotal studies to the FDA. Per the Prescription Drug User Fee Act ("PDUFA"), the FDA has 45 calendar days to provide comments back to Repros.

"We believe that Repros has addressed all of the issues and recommendations the Agency raised during the May 9th meeting held to discuss the registration program for Androxal®," stated Joe Podolski, President and Chief Executive Officer of Repros Therapeutics. "Repros is now required to wait for FDA comment before starting the pivotal studies. While there can be no assurances that the first submission will be successful, we are optimistic about the outcome of our discussions with the Agency."

In other news, the Company expects to commence screening subjects next week in a 500 patient open label study designed to demonstrate the safety of Androxal® as well as complete a draft of a one year DEXA study for submission to FDA for review. The Company has initiated over 25 US clinical sites for the open label study and is reviewing which sites will be appropriate for the SPA studies as currently designed. Neither the open label nor DEXA studies are part of the SPA review process.

Depending on the SPA review process, study enrollment and the completion of the DEXA trial, the Company believes it may be able to submit an NDA around the end of 2013.

About Repros Therapeutics Inc.

Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.

The Repros Therapeutics Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7738

Any statements made by the Company that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including the ability to raise additional needed capital on a timely basis in order for it to continue to fund development of its Androxal® and Proellex® programs, have success in the clinical development of its technologies, the reliability of interim results to predict final study outcomes, and such other risks which are identified in the Company's most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information, please visit the Company's website at http://www.reprosrx.com.

CONTACT: Repros Therapeutics Inc.
         Joseph Podolski (281) 719-3447
         President and Chief Executive Officer

         Investor Relations:
         The Trout Group
         Thomas Fechtner
         (646) 378-2931