Repros Therapeutics Inc. ("we", "us" or "our") was organized on August 28, 1987. We are a development stage biopharmaceutical company focused on the development of oral small molecule drugs to address major unmet medical needs in male and female health.
Our current product pipeline (with the respective status of development) consists of the following:
Proellex® (female reproductive health)
On August 3, 2009, Repros Therapeutics announced it voluntarily suspended dosing of all patients in its clinical trials of Proellex. On August 4, 2009, the United States Food and Drug Administration (FDA) informed Repros that the Company’s Investigational New Drug Applications (INDs) for Proellex had been placed on clinical hold for safety reasons.
- Phase 3 — three-month pre-surgical treatment for women with anemia due to excessive menstrual bleeding associated with uterine fibroids, or anemia associated with uterine fibroids, who may consider having a subsequent hysterectomy
- Phase 3 — chronic treatment of symptoms associated with uterine fibroids
- Phase 2 — chronic treatment of symptoms associated with endometriosis
Androxal® (male reproductive health)
- Phase 2b proof-of-concept trial in men being treated for low testosterone levels who want to improve or maintain their fertility and/or sperm number and function
- We intend to file an Investigational New Drug Application, or IND, in the second half of 2009 for Androxal as a potential treatment for type 2 diabetes
Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and previously was primarily being developed for the chronic treatment of symptoms associated with uterine fibroids and endometriosis. During the first quarter of 2008 we filed an Investigational New Drug application for Proellex for a new indication as a three-month pre-surgical treatment for women with anemia due to excessive menstrual bleeding associated with uterine fibroids.
Uterine fibroids, anemia associated with uterine fibroids and endometriosis affect a significant number of women of childbearing age in the developed world. There is no currently-approved effective long-term drug treatment for uterine fibroids or endometriosis. In the United States alone, approximately 300,000 women per year undergo a hysterectomy as a result of severe uterine fibroids.
Our common stock is traded on the NASDAQ Global Market under our ticker symbol, RPRX.
Available Information
For additional information please visit the Securities and Exchange Commission (SEC) Internet site (www.sec.gov) which makes available free of charge to all interested parties our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments to those reports, as well our proxy information and statements and all other reports and schedules filed electronically with the SEC. The SEC website can also be accessed through this website under Investors and Media – SEC Filings.