HRA Pharma commences US Phase III trial of second-generation emergency contraceptive
Paris, France - 7 December, 2006 - HRA Pharma today announced the start of a pivotal multi-centre Phase III study evaluating its proprietary second-generation emergency contraceptive - Ella®. The study will be conducted in sixteen clinics affiliated with Planned Parenthood Federation of America (PPFA) in seven different US states.
Dr. Andre Ulmann, CEO of HRA Pharma: “Every year millions of women find themselves in need of emergency contraception.This is therefore an important trial of a contraceptive that could offer significant benefits for many women worldwide. The drug holds a great deal of promise and may present some real advantages for emergency contraception.”
The purpose of the open-label investigation is to confirm the safety and efficacy of Ella® (otherwise known as CDB-2914) as an emergency contraceptive. Over one thousand 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 (5 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, after 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” said Vanessa Cullins, PPFA VP for Medical Affairs. ”Planned Parenthood welcomes innovations that expand contraceptive choices and increase family planning options”.
Results of a successful double-blind comparison of CDB-2914 versus levonorgestrel for emergency contraception were published by Creinin et al in the November 2006 issue of Obstetrics & Gynecology.
Full details of this clinical study and directions for potential volunteers can be found at www.clinicaltrials.gov <http://www.clinicaltrials.gov>.
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Reference: Creinin et al, ‘Progesterone receptor modulator for emergency contraception’, Obstetrics and Gynecology, Vol. 108, No 5, November 2006
About HRA Pharma
HRA Pharma is a private pharmaceutical company based in Paris, France. The Company creates innovative medicines and products for women’s and reproductive health, hormonal cancer treatments and cell-based therapies.
HRA Pharma has a proven track record of developing and commercializing products in its key therapeutic areas. Its first product, NorLevo® emergency contraception, launched in France in 1999, is now available in over 50 countries. The Company’s other products include Gymiso®, a prostaglandin for use in obstetrics and gynecology, Cicatridine® which promotes vaginal healing, Mona-Lisa®, a copper contraceptive IUD (intrauterine device), and Lysodren®, for the treatment of adrenal cortical carcinoma. Three of HRA’s products have received national awards for their usefulness to patients. In addition, HRA also has distribution rights in France for eight products from Orion Pharma's (Finland) portfolio in the fields of oncology, pneumology, gynecology and neurology.
As well as its marketed products, the Company has an internal pipeline of new products in development in women’s and reproductive health and hormonal cancer therapy. HRA is also developing cell medicines for the treatment of anal and urinary incontinence, and ocular myopathy through its alliance with Celogos, a biotech company also based in France.
HRA Pharma was founded by a team of medical specialists who genuinely care about global healthcare. The Company has invested significant effort in establishing strong links with international NGOs and local authorities, which enable it to help meet the needs of women who might otherwise be unable to afford appropriate treatments/products.
For further information please visit the website at www.hra-pharma.com <http://www.hra-pharma.com>
About PPFA
Planned Parenthood Federation of America is the nation's leading sexual and reproductive health care advocate and provider. We believe that everyone has the right to choose when or whether to have a child, and that every child should be wanted and loved. Planned Parenthood affiliates operate more than 860 health centers nationwide, providing medical services and sexuality education for millions of women, men, and teenagers each year. We also work with allies worldwide to ensure that all women and men have the right and the means to meet their sexual and reproductive health care needs.
For further information, visit www.plannedparenthood.org <http://www.plannedparenthood.org>
