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Watson Confirms Columbia Laboratories' Filing of Definitive Proxy Relating to Watson's Acquisition of U.S. Rights to CRINONE® Progesterone Gel Product Line
Date:6/1/2010

class="xn-location">Columbia.  If Columbia and Watson are successful in receiving FDA approval for a new pre-term birth indication, we will have the opportunity to address a significant and unmet medical need."

The acquisition remains subject to customary closing conditions, including the approval of Columbia's stockholders.  After the close of the acquisition, Watson intends to immediately begin marketing CRINONE® and PROCHIEVE® for approved indications in the U.S. to reproductive endocrinologists and Ob/Gyns through the existing Brand Sales Forces.  

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®.

A Phase 3 clinical program is currently underway in collaboration with the National Institutes of Health (NIH) to evaluate the safety and efficacy of PROCHIEVE® for the prevention of pre-term birth in women with a short cervix.  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, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignanc
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SOURCE Watson Pharmaceuticals, Inc.
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