12/16/2010 6:39:38 AM
BUDAPEST, HUNGARY, Dec. 16, 2010 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) ("Watson") and Gedeon Richter Plc ("Richter") today announced that Watson's subsidiary, Watson Laboratories, Inc. has entered into an exclusive licensing agreement with PregLem, S.A., ("Preglem") the wholly owned subsidiary of Richter, to develop and market Esmya (ulipristal acetate) in the U.S. and Canada. In European studies, Esmya has been shown to be an effective and safe treatment for uterine fibroids (myoma), a condition that affects millions of women worldwide. The product is currently in late stage development in Europe and Watson expects to initiate U.S. Phase III clinical studies in 2011.
Under terms of the agreement, Watson will pay PregLem a $17 million license fee and will pay royalties based on sales in the U.S. and Canada. Watson will make additional payments based on the achievement of certain regulatory milestones. The companies will also collaborate on additional Esmya formulations, jointly sharing the development costs.
"Esmya represents a significant strategic addition to our portfolio of women's health products and is potentially the first effective treatment for uterine fibroids in more than 20 years," said Paul Bisaro, Watson's Chief Executive Officer. "The agreement enables us to maximize our expertise in developing, registering and commercializing significant therapeutic advances in diseases treated by OB/GYNs. It also forms the foundation for us to further develop a franchise of products and indications in the uterine fibroid category. We look forward to further expanding our relationship with PregLem and Gedeon Richter for future opportunities between our companies."
"I am pleased with the agreement concluded with Watson, as their specialty knowledge and marketing strength are expected to contribute to the successful development and marketing of Esmya in North America. I am convinced that via the acquisition of PregLem and the commercialisation of Esmya, we will create increasing value for our investors", said Erik Bogsch, Managing Director of Gedeon Richter Plc.
"Esmya has successfully completed clinical trials in Europe, so we have significant clinical knowledge and confidence in the development requirements as we move to late-stage trials in the U.S. and Canada," said Ernest Loumaye, CEO and Co-Founder of PregLem.
Uterine fibroids (myomas) are the most common benign, solid tumors of the female genital tract, affecting between 20 and 25 percent of women of reproductive age. The condition is characterized by excessive uterine bleeding, anemia, pain, frequent urination or incontinence, and occasional interruption of fertility. Approximately 300,000 surgical procedures are performed annually to address uterine fibroids, including approximately 230,000 hysterectomies. GnRH agonists are the only approved treatment for uterine fibroids when associated with anemia but their use has been relatively limited due to side effects resulting from the suppression of estrogen to castration levels (hot flushes, depression, mood swings, loss of libido, vaginitis and loss of bone mineral density).
Ulipristal acetate is a first-in-class, orally active selective progesterone receptor modulator which reversibly blocks the progesterone receptors in target tissues. PregLem has completed clinical trials in Europe, and is initiating the registration procedure in the EU. PregLem will market Esmya in Europe.
Richter is a leading multinational pharmaceutical company headquartered in Budapest, Hungary. With consolidated sales of approximately EUR 1 billion (US$1.3 billion) in 2009 and a market capitalization of EUR 3.2 billion (US$4.3 billion), Richter has a growing presence in the US through its strategic partners and in key EU countries through its commercial subsidiaries. The product portfolio of the company covers most therapeutic areas, including cardiovascular, central nervous system and gynaecology. Richter has the largest R&D unit in Central Eastern Europe and its original research activity focuses exclusively on CNS disorders with main clinical targets being schizophrenia, anxiety, chronic pain and depression. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the female healthcare field worldwide.
For more information: www.Richter.hu
PregLem is a Swiss speciality biopharmaceutical company, dedicated to the development and commercialization of a new class of drugs for women's reproductive health conditions. PregLem has an experienced senior management team, with a proven track record in developing, registering and commercializing reproductive health products. The company is owned by Gedeon Richter, a leading multinational pharmaceutical company headquartered in Budapest, Hungary. Visit www.preglem.com for more information.
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®, Crinone® and INFeD®. In addition, Watson markets the following brands under co-promotion agreements: AndroGel®, with Abbott Laboratories, and Femring®, with Warner Chilcott Limited. The Watson brand pipeline portfolio includes a number of products, including Prochieve®, under development with Columbia Laboratories for prevention of pre-term birth in women with a short cervix, recombinant follicle stimulating hormone (rFSH) in development with Itero Biopharmaceuticals for female infertility, and three novel new contraceptives.
For press release and other company information, visit Watson Pharmaceuticals' Web site at 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. 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 Watson's business. These factors include, among others, the difficulty of predicting the timing and outcome of product development efforts, including FDA and other regulatory approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; 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, its subsidiaries, and its 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 on Form 10-K for the year ended December 31, 2009 and Watson's quarterly report on Form 10-Q for the period ended September 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. All trademarks are the property of their respective owners.
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SOURCE Watson Pharmaceuticals, Inc.