Agreement follows FDA approval of ella(R) in the U.S., where Watson will market the product
PARIS and MORRISTOWN, N.J., Sept 17, 2010 /PRNewswire via COMTEX/ --
HRA Pharma, a privately-held, European pharmaceutical company that develops healthcare solutions in reproductive health and endocrinology and makes them available worldwide, and Watson Pharmaceuticals, Inc. (NYSE: WPI) announced today that they have entered into a licensing agreement for the commercialization of HRA Pharma's next generation emergency contraceptive ulipristal acetate in Canada.
This agreement marks the next step for the commercialization of ulipristal acetate in North America and the second collaboration between the two companies in the field of reproductive health. Recently, the U.S. Food and Drug Administration (FDA) approved ulipristal acetate, which Watson will market in the U.S. under the name ella(R), as a prescription-only emergency contraceptive. HRA Pharma plans to file a New Drug Submission for ulipristal acetate with Health Canada before the end of 2010. If approved, Watson will be responsible for marketing and commercialization of ulipristal acetate in Canada.
"HRA Pharma strives to improve reproductive health with products and services that are accessible to women worldwide, and Watson continues to share this mission with us," said Dr. Erin Gainer, CEO, HRA Pharma. "We are excited to expand our partnership with Watson for ulipristal acetate into Canada. Our two companies share the commitment to making emergency contraception with ulipristal acetate available to women across North America."
"As Watson continues to prepare for the fourth quarter 2010 launch of the ella(R) (ulipristal acetate) emergency contraceptive in the U.S., we are pleased that if approved in Canada, Watson will be responsible for bringing this important emergency contraceptive to women across North America," said Fred Wilkinson, Executive Vice President, Watson Global Brands. "We are committed to expanding our women's health product franchise, and expanding our marketing presence globally with products that offer additional options and meet unmet medical needs. Extending our marketing relationship with HRA into Canada represents continued progress in achieving our vision for Watson as a leader in women's health."
Ulipristal acetate is a novel oral emergency contraceptive designed and developed by HRA Pharma. It was approved in May 2009 by the European Commission and in August 2010 by the FDA as safe and effective in preventing unintended pregnancy for up to 120 hours - or five days - post- unprotected intercourse or contraceptive failure. Marketed since October 2009 in Europe under the brand name ellaOne(R), Watson plans to launch the product in the U.S. market as ella(R) in the fourth quarter of 2010.
Important Safety Information
The most common side effects of ella(R) (ulipristal acetate) tablets include headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%), and dizziness (5%). ella(R) is contraindicated in women with a known or suspected pregnancy, and should not replace a regular method of contraception. Repeated use of ella(R) within the same menstrual cycle is not recommended. ella(R) is not indicated for termination of an existing pregnancy. Women who become pregnant or complain of lower abdominal pain after taking ella(R) should be evaluated for ectopic pregnancy. ella(R) may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out. A rapid return of fertility is likely following treatment with ella(R). Therefore, routine contraception should be continued or initiated as soon as possible to ensure ongoing prevention of pregnancy. ella(R) does not protect against STI/HIV.
About HRA Pharma
HRA Pharma is a privately-held European pharmaceutical company that develops healthcare solutions in reproductive health and endocrinology and makes them available worldwide. The company is committed to understanding evolving health needs and to developing innovative solutions and actions that allow for equal access to its products amongst patients and physicians throughout the globe. Founded in 1996, HRA Pharma is a pioneer in emergency contraception. Its product ulipristal acetate can be taken for up to five days after unprotected sexual intercourse and is the only product licensed in the European Union (ellaOne(R)) and in the U.S. (ella(R)) for this indication. Headquartered in Paris, France and with offices in Germany, Italy, Spain, France and the UK, HRA Pharma has built a strong network of R&D, manufacturing, distribution and NGO partners in over 50 countries. For more information, visit http://www.hra-pharma.com.
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(R), GELNIQUE(R), Oxytrol(R), TRELSTAR(R), Crinone(R) and INFeD(R). In addition, Watson markets the following brands under co-promotion agreements: AndroGel(R), with Solvay Pharmaceuticals, Inc., and Femring(R), with Warner Chilcott Limited. The Watson brand pipeline portfolio includes a number of products, including URACYST(R), under development for cystitis; and three novel new contraceptives in addition to ella(R).
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
HRA Pharma Disclaimer
This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements.
Watson Forward-Looking Statement
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 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, Health Canada, 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 and similar laws in Canada 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 June 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
CONTACTS: For HRA Pharma:
+33 (0)1 42 22 24 10
Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc.
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SOURCE Watson Pharmaceuticals, Inc.; HRA Pharma