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HRA Pharma commences UK-based Phase III trial of Ella®, a second-generation emergency contraceptive Paris, France – 26 March 2007 – HRA Pharma today announced recruitment has begun into a UK-based pivotal Phase III study to evaluate the Company’s second-generation emergency contraceptive, Ella®. The study will be conducted across nine NHS family planning clinics in the UK. The purpose of this investigation is to confirm the safety and efficacy of Ella® (otherwise known as CDB-2914) as an emergency contraceptive. The trial will recruit some two thousand women over the course of nine months. Women over 16 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, following EMEA approval, to launch Ella® in Europe in 2009. 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. Dr. André Ulmann, CEO of HRA Pharma commented: “Every year millions of women worldwide find themselves in need of emergency contraception. Together, this trial and our multi-centre US trial that was launched last December are really important for these women. Our second-generation contraceptive is the first compound ever to have been developed specifically for emergency contraception. It holds a great deal of promise and offers some real advantages compared with existing emergency contraceptives.” For more information on the clinical trial and eligibility criteria or to find instructions for potential volunteers, log on to www.clinicaltrials.gov. – ENDS – 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, endocrine diseases 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 60 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 For further information please contact:
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