MORRISTOWN, N.J., Aug. 13 Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced that it intends to launch ellaŽ (ulipristal acetate), a novel oral emergency contraceptive, in the fourth quarter of 2010. Watson's announcement follows the approval of ellaŽ by the FDA as safe and effective in preventing unintended pregnancy for up to 120 hours - or five days - post-unprotected intercourse (UPI) or contraceptive failure. ellaŽ was developed by HRA Pharma specifically for emergency contraception and is not intended for routine contraceptive use. ellaŽ will be marketed by Watson in the United States under terms of an exclusive distribution agreement announced earlier this year.
Watson, which has been aggressively expanding its portfolio of women's health products, recognizes a significant need for additional emergency contraceptive options and will work with physicians, health care providers and consumers to educate them on the value of ellaŽ's unique efficacy profile.
ellaŽ is a progesterone agonist/antagonist emergency contraceptive and is proven effective in helping prevent pregnancies at various stages of the menstrual cycle, including just before ovulation - the very time in a woman's cycle when the probability of pregnancy is highest. ellaŽ is effective in delaying ovulation for up to five days. This is important, because sperm can survive for up to five days in the genital tract.
Currently available over-the-counter levonorgestrel-based emergency contraceptives are indicated for use within 72 hours of unprotected intercourse or contraceptive failure and their effectiveness in preventing pregnancy decreases just prior to ovulation.(i)
"ellaŽ is an important new contraceptive option for U.S. women, and its unique efficacy profile will give women an additional therapeutic alternative for preventing unintended pregnancy," said Fred Wilkinson, Executive Vice President, Global Brands at Watson. "Beginning later this year, Watson will be offering women a novel emergency contraceptive that represents a logical, therapeutic complement to NextChoiceŽ, our generic levonorgestrel-based emergency contraceptive."
The approval of ellaŽ is based on data from pivotal clinical studies that enrolled more than 2,600 women. Throughout its extensive clinical investigation, ellaŽ consistently demonstrated safe and effective pregnancy prevention. Among women who were administered ellaŽ within 72 hours of UPI, the overall pregnancy rate was 1.9%, significantly lower than the anticipated pregnancy rate (5.6%). Among women who were administered ellaŽ 48-120 hours post-UPI, the overall pregnancy rate was 2.2% -- again, significantly lower than the expected pregnancy rate (5.5%).
ellaŽ will be available to U.S. women, by prescription only, beginning in the fourth quarter of this year and will be marketed by Watson's Global Brands division. Recent partnerships with HRA Pharma, the Population Council and Columbia Laboratories have enabled Watson to expand its branded offerings and pipeline in women's health to include infertility, emergency contraception, long-term contraception and pre-term birth.
Ulipristal acetate has been available in Europe since October 2009, where it is marketed by HRA Pharma as ellaOneŽ.
Emergency Contraception - the Unmet Need
The technology of prophylactic contraception is imperfect. Condoms break. Oral contraceptives can and do fail. Even female sterilization, assumed by many women to be 100 percent effective, is associated with a failure rate of 0.5% during the first year.(ii)
Approximately three million unintended pregnancies occur each year. Nearly half (48%) of these unintended pregnancies are among women using regular methods of birth control where a failure occurred.(iii)
According to the Centers for Disease Control and Prevention (CDC), unintended pregnancy can be associated with an increased risk of morbidity for women - as well as with health behaviors during pregnancy that are associated with adverse events, including a delay in prenatal care.(iv)
Important Safety Information
The safety and tolerability of ellaŽ have been extensively evaluated and established. Among the more than 2,600 women who have received ellaŽ 30 mg in clinical trials, the most commonly reported adverse events in the open-label and single-blind studies, respectively, were mild to moderate headache (18%/19%), nausea (12%/13%), abdominal and upper abdominal pain (15%/8%), dysmenorrhea (7%/13%), fatigue (6%/6%) and dizziness (5%/5%) - a profile similar to that of other available oral emergency contraceptives.
ellaŽ is should not be used during an existing or suspected pregnancy, and women who become pregnant or complain of lower abdominal pain after taking ellaŽ should be examined for the possibility of an ectopic pregnancy. Repeated use of ellaŽ within the same menstrual cycle is not recommended, and because a rapid return of fertility is likely following use of ellaŽ, routine contraception should be continued or initiated as soon as possible. ellaŽ does not protect against HIV (AIDS) or other sexually transmitted infections.
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 RAPAFLOŽ, GELNIQUEŽ, OxytrolŽ, TRELSTARŽ, CrinoneŽ and INFeDŽ. In addition, Watson markets the following brands under co-promotion agreements: AndroGelŽ, with Solvay Pharmaceuticals, Inc., and FemringŽ, with Warner Chilcott Limited. The Watson brand pipeline portfolio includes a number of products, including URACYSTŽ, under development for cystitis; and three novel new contraceptives in addition to ellaŽ. 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 ulipristal acetate can be taken for up to five days after unprotected sexual intercourse and is the only product licensed in the European Union (ellaOneŽ) and the U.S. (ellaŽ) 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 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 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 June 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
(i) Durand et al., 2001; Hapangama et al., 2001; Marions et al., 2002; Croxatto et al., 2004; Massai et al., 2007; Novikova et al., 2007
(ii) The Guttmacher Institute, "Facts in Brief: Facts on Contraceptive Use" available at http://www.guttmacher.org/pubs/fb_contr_use.html. Accessed on March 24, 2010.
(iii) ella(One) QA General (provided by HRA Pharma), p.1
(iv) Centers for Disease Control and Prevention, "Unintended Pregnancy Prevention: Home," available at http://www.cdc.gov/reproductivehealth/UnintendedPregnancy/index.htm. Accessed on March 24, 2010.
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SOURCE Watson Pharmaceuticals, Inc.