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Watson Completes Acquisition of CRINONE® and PROCHIEVE® Product Line and Shares of Columbia Laboratories
Date:7/2/2010

competing products 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 is 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.

Important Safety Information

The most common side effects of CRINONE® include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain.  CRINONE® is contraindicated in patients with an active thrombophlebitis or thromboembolic disorders, or a history of thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company.  Watson is engaged in the development and distribution of
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SOURCE Watson Pharmaceuticals, Inc.
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