Watson and HRA Pharma Announce Exclusive Licensing Agreement to Commercialize Novel Emergency Contraceptive in the U.S.
MORRISTOWN, N.J., Feb. 1 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) and HRA Pharma today announced an exclusive licensing agreement for Watson to become the commercial partner for ulipristal acetate (UPA), a selective progesterone receptor modulator in the U.S. UPA is a novel next-generation emergency contraceptive developed by HRA Pharma specifically for emergency contraceptive use that is approved and marketed by HRA Pharma in Europe as ellaOne® since October 2009. UPA is at the New Drug Application (NDA) stage in the U.S.
According to the data recently published in The Lancet, which evaluated the efficacy of UPA as compared to levonorgestrel for emergency contraception among 1696 women in the United Kingdom, Ireland and the United States, UPA provides effective, alternative emergency contraception for up to five days after unprotected sexual intercourse.
Under the terms of the licensing agreement, Watson will make payments to HRA Pharma, based on the achievement of certain milestones. In addition, Watson will also pay HRA Pharma a royalty on U.S. sales of the product. Watson will be responsible for all U.S. commercialization and marketing expenses.
"The opportunity to collaborate with HRA Pharma on the U.S. commercialization of UPA fits nicely within our broader strategy to expand our emerging position in women's health care and to provide women with a vast array of safe, effective treatment options in contraception as well as other important therapeutic areas," said Fred Wilkinson, Watson's executive vice president, Global Brands. "The published clinical results are significant, and we are optimistic about the prospects of providing U.S. women with a new emergency contraceptive option."
"We are excited to further our international expansion by partnering with Watson to bring UPA to the U.S.," said Erin Gainer, CEO of HRA Pharma. "For over a decade, our mission has been to design custom-made solutions in women's health that fill therapeutic gaps and improve overall patient health. Our first step into the U.S. with Watson, who shares this same commitment to women's health care, represents a crucial milestone for us in our vision of making UPA available to women worldwide."
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® LA and TRELSTAR® Depot 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 a six-month formulation of TRELSTAR®, for the treatment of advanced prostate cancer which is currently under review by the FDA; URACYST®, under development for cystitis; and two novel new oral 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.
About HRA Pharma
HRA Pharma is a privately-held European pharmaceutical company that designs products, devices and supporting services in niche areas of health and makes them available to doctors and patients worldwide. The company targets therapeutic gaps in the areas of reproductive health and endocrinology, and uses innovative marketing solutions and socially-conscious programs, such as contraception education in developing countries, to promote healthy management of drugs and diseases. A pioneer in emergency contraception, its product ellaOne can be taken for up to five days after unprotected sexual intercourse and is the only product licensed in the European Union for this indication. Headquartered in Paris, France and with offices in Germany, Italy, Spain and the UK, HRA Pharma has built a strong network of R&D, manufacturing, distribution and NGO partners which enables it to satisfy critical patient needs and improve patient health in over 50 countries across the globe. Visit http://www.hra-pharma.com for more information.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. For instance, any statements in this press release concerning prospects related to Watson's strategic initiatives, product introductions and anticipated financial performance are forward-looking statements. It is important to note that Watson's goals and expectations are not predictions of actual performance. Watson's performance, at times, will differ from its goals and expectations. 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 impact of competitive products and pricing; 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; the uncertainty associated with the identification and successful consummation of external business development transactions; market acceptance of and continued demand for Watson's products; costs and efforts to defend or enforce intellectual property 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's 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 period ended December 31, 2008 and quarterly report on Form 10-Q for the period ended September 30, 2009. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
SOURCE Watson Pharmaceuticals, Inc.