Repros Therapeutics Inc. Announces Amendment to NIH License Agreement
2009 JUL 20 - (NewsRx.com) -- Repros Therapeutics, Inc. (NasdaqGM:RPRX) ("Repros" or the "Company") announced that it entered into the Sixth Amendment to its Agreement (the "Agreement") with the National Institutes of Health ("NIH") (the "Amendment") relating to the Company's lead product Proellex. The Amendment clarified that certain cancers related to the human reproductive system are within the scope of the licensed field, amended the development and commercialization benchmarks that the Company is required to meet under the Agreement and added or modified certain milestone payments due to NIH on the achievement of certain benchmarks. Most significantly, the Amendment revised the dates by which certain development and commercialization benchmarks must be met. These revisions include an extension of the date by which the Company is required to submit to the Food and Drug Administration a new drug application ("NDA") covering a licensed product in the United States for a first indication from June 30, 2009 to June 30, 2011. Notwithstanding this extension, as previously reported, Repros remains committed to its target date for an initial submission of an NDA for Proellex in the second half of 2010. In addition, under the Amendment, the Company is required to obtain financing, upfront licensing consideration, or any combination thereof, of no less than a combined total of $6,000,000 by September 30, 2009. The Amendment also (1) extended the dates by which certain other benchmarks must be met, including benchmarks relating to filing for approval of a licensed product in Europe and Japan, the filing of an NDA for a licensed product in a second indication in the United States, and the application for regulatory approval for a licensed product in a second indication in Europe and Japan, and (2) added benchmarks relating to initiation of Phase 3 clinical trials in Europe and Japan for a licensed product in a second indication. Failure to meet these benchmarks could result in modification or termination of the Agreement. The Company is obligated to pay NIH an amendment issue royalty in the amount of $100,000 in connection with the Amendment. A copy of the Amendment will be filed as an Exhibit to a Current Report on Form 8-K to be filed by the Company with the Securities and Exchange Commission and the foregoing summary of certain terms of the Amendment is qualified in its entirety by reference to the actual Amendment. About Repros Therapeutics Repros focuses on the development of oral small molecule drugs for major unmet medical needs associated with male and female reproductive disorders. Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. We are also developing Proellex as a short course pre-surgical treatment for anemia associated with excessive menstrual bleeding related to uterine fibroids. There is no currently approved orally administered drug for the long-term treatment of uterine fibroids or endometriosis. In the United States alone, 300,000 women per year undergo a hysterectomy as a result of severe uterine fibroids. Keywords: , Health, Biotechnology, Clinical Trials, Pharmaceutical, Asia, Food, JapanBiotechnology, Drug Development, Marketing and Licensing Agreements, Regulatory Actions, Therapy, Treatment, Repros Therapeutics Inc. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.
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