Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that shareholders of Columbia Laboratories, Inc. (Nasdaq: CBRX) have approved the terms and conditions of the previously announced acquisition by Watson of the U.S. rights to Columbia's CRINONE® and PROCHIEVE® progesterone gel product line and 11,200,000 shares of Columbia common stock.
The acquisition remains subject to customary closing conditions. After the close of the acquisition, Watson intends to immediately begin marketing CRINONE® and PROCHIEVE® in the U.S. to reproductive endocrinologists and Ob/Gyns through Watson's Brand Sales Forces as well as expanding its sales effort with the addition of approximately 19 sales representatives that marketed these products for Columbia. The acquisition is expected to close within three business days.
CRINONE® is currently used for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with a progesterone deficiency. Patient preference for CRINONE® has been demonstrated in five clinical trials. The product is also available under the trade name PROCHIEVE® and available in both a 4% and 8% concentrations. PROCHIEVE® 4% is indicated for the treatment of secondary amenorrhea.
A Phase 3 clinical program called the PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study is currently underway to evaluate the safety and efficacy of PROCHIEVE® 8% (progesterone gel) to reduce the risk of pre-term birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint of this study is a reduction in the incidence of pre-term birth at less than or equal to 32 weeks gestation vs. placebo. With enrollment in the program complete, preliminary top-line study results are expected at the end of 2010. If the data are positive, a NDA filing will follow in 2011. Pre-term birth occurs in one of every eight live born infants, and short cervix is the single most important predictor of pre-term birth. There are currently no products approved for the prevention of pre-term birth.
Watson Pharmaceuticals, Inc.