Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced that it intends to launch ella® (ulipristal acetate), a novel oral emergency contraceptive, in the fourth quarter of 2010. Watson's announcement follows the approval of ella® 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. ella® was developed by HRA Pharma specifically for emergency contraception and is not intended for routine contraceptive use. ella® 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 ella®'s unique efficacy profile.
ella® 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. ella® 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.
"ella® 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 NextChoice®, our generic levonorgestrel-based emergency contraceptive."
The approval of ella® is based on data from pivotal clinical studies that enrolled more than 2,600 women. Throughout its extensive clinical investigation, ella® consistently demonstrated safe and effective pregnancy prevention. Among women who were administered ella® 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 ella® 48-120 hours post-UPI, the overall pregnancy rate was 2.2% -- again, significantly lower than the expected pregnancy rate (5.5%).
ella® 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 ellaOne®.
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.
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.
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.
Watson Pharmaceuticals, Inc.