MORRISTOWN, N.J., June 1 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that Columbia Laboratories, Inc. has filed with the Securities and Exchange Commission a definitive proxy seeking Columbia shareholder approval of the previously announced agreement under which Watson would acquire the U.S. rights to Columbia's CRINONE® and PROCHIEVE® product line and 11,200,000 shares of Columbia common stock.
Additionally, Watson confirmed that it has entered into a $15 million loan agreement with Columbia to support Columbia's ongoing investment in the clinical development of the pre-term birth indication for PROCHIEVE®, as well as other Columbia capital requirements. If the acquisition transaction with Columbia closes before December 31, 2011, all principal and accrued interest on the loan will be forgiven.
"Filing the proxy represents a significant step towards the closing of our acquisition, which will permit both Watson and Columbia shareholders to begin to realize the value of our proposed partnership," said Paul Bisaro, Watson's President and Chief Executive Officer. "Our forgivable loan to Columbia demonstrates Watson's commitment to supporting the clinical development activities related to PROCHIEVE's expanded pre-term birth indication and to our collaboration with 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 malignancy of the breast or genital organs.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company 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 markets the following brands under co-promotion agreements: AndroGel®, with Solvay Pharmaceuticals, Inc., and Femring®, with Warner Chilcott Limited. The Watson Brand pipeline portfolio includes a number of products, including URACYST®, under development for cystitis; and four novel new contraceptives. All other trademarks are property of their respective owners.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. For example, any statements in this press release concerning the anticipated closing of the acquisition, the anticipated benefits of the acquisition, future approvals or other events related to products or future products and Watson's strategic initiatives and business plans are forward-looking statements. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting the acquisition or Watson's business. These factors include, among others, the risk of not completing the acquisition for any reason, including as result of third party intervention; successful integration of the Columbia products and product rights; the impact of competitive products and pricing; timely and successful consummation and implementation of strategic initiatives; the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; costs and efforts to defend or enforce intellectual property and contractual rights; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson, their third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's annual report for the year ended December 31, 2009 and quarterly report for the period ended March 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
SOURCE Watson Pharmaceuticals, Inc.