HRA PHARMA BEGINS PHASE III TRIAL OF EMERGENCY CONTRACEPTIVE

HRA Pharma has announced the start of a pivotal, multicenter, Phase III study evaluating its proprietary second-generation emergency contraceptive, Ella. The study will be conducted in 16 clinics affiliated with Planned Parenthood Federation of America (PPFA) in seven states.

The purpose of the open-label investigation is to confirm the safety and efficacy of Ella (CDB-2914) as an emergency contraceptive. More than 1,000 women will volunteer to participate in the trial. Women over 18 years old who request emergency contraception from one of the participating sites within 120 hours (five days) of unprotected sexual intercourse or a contraceptive failure may be eligible for the study. HRA Pharma expects to complete the study by the end of 2007 and, upon FDA approval, to launch Ella in the U.S. by 2009.

"CDB-2914 is the first compound ever to have been developed expressly with emergency contraception in mind" Vanessa Cullins, PPFA vice president for medical affairs, said.

Results of a successful double-blind comparison of CDB-2914 and levonorgestrel for emergency contraception were published in the November issue of Obstetrics & Gynecology.