BUDAPEST, HUNGARY and MORRISTOWN, New Jersey – 16 December, 2010 — Gedeon Richter Plc. (“Richter”) and Watson Pharmaceuticals, Inc. (NYSE: WPI) (“Watson”) today announced that PregLem, S.A., (“Preglem”) the wholly owned subsidiary of Richter has entered into an exclusive licensing agreement with Watson’s subsidiary, Watson Laboratories, Inc. 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.
“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 commercialization 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.
“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 Gedeon Richter and PregLem for future opportunities between our companies.”
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 it 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.
For more information: www.preglem.com
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 more information: www.watson.com
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