Watson Pharmaceuticals, Inc 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 US women, and its unique efficacy profile will give women an additional therapeutic alternative for preventing unintended pregnancy," said Fred Wilkinson, executive VP, 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 US 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.