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Watson Confirms Columbia Laboratories Shareholder Approval of Proposed Acquisition of Progesterone-related Assets
Date:7/1/2010

erway 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.

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 active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated 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 generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health.  Watson has operations in many of the world's established and growing international markets.

In the U.S., the Watson Brand portfolio includes RAPAFLO®, GELNIQUE®, Oxytrol®, TRELSTAR® and INFeD®.  In addition, Watson ma
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SOURCE Watson Pharmaceuticals, Inc.
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