Breaking News in Emergency Contraception: HRA Pharma Unveils Clinical Data on ellaOne

Groundbreaking clinical trials on new generation emergency contraceptive published simultaneously in The Lancet and Obstetrics & Gynecology

Paris, France – January 29, 2010 – HRA Pharma, a privately-held European pharmaceutical company that designs innovative solutions for reproductive health and endocrinology, announced today that key clinical results on its recently-approved emergency contraceptive ellaOne® (ulipristal acetate) have been published in the February issues of two leading scientific journals, The Lancet and Obstetrics & Gynecology. In The Lancet’s press release accompanying today’s publication of the article, the world's leading medical journal states: ?New research shows that the emergency contraception drug ulipristal acetate (UA) prevents more pregnancies than a widely-used alternative, levonorgestrel […]. Thus women and health-care providers now have an alternative choice for emergency contraception.?

The Lancet and Obstetrics and Gynecology reports capture the results of a broad-scale international clinical development program designed to evaluate the efficacy of ulipristal acetate, HRA Pharma’s progesterone receptor modulator, as a method of emergency contraception. Engineered and sponsored by the company, the trials were carried out in partnership with leading reproductive health experts in Europe and the United States and involved 33 investigators and 80 clinics, with more than 4,000 women participating in the trials. The product was approved by the European Union in May 2009 and has since been launched under the trademark ellaOne in 17 countries.

?The publication of this clinical data enables us to share our research results with the scientific community, as well as recognize our strong network of partners that were involved in seeing this program through to fruition,? said Dr. Erin Gainer, CEO of HRA Pharma. ?It is also a testament to HRA Pharma’s commitment to designing therapeutic solutions that satisfy critical patient needs in reproductive health, and our ability to successfully bring these solutions to market. We will continue to pursue strategic R&D opportunities and partnerships with this mission in mind—tailored projects having the potential to enable women to take greater control of their own health.?

A pioneer in emergency contraception since 1999, HRA Pharma has been committed to developing and marketing innovative and custom-made solutions to unmet therapeutic needs in the fields of reproductive health and endocrinology. As part of its pipeline, the company designed and developed ulipristal acetate for use as an emergency contraceptive. ellaOne can be taken for up to five days after unprotected sexual intercourse and is the only product licensed for this indication. HRA Pharma intends to register the product in countries worldwide. The company continues to explore potential applications for ulipristal acetate in additional areas of reproductive health, and the compound is currently undergoing clinical trials for the treatment of uterine fibroids.

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About HRA Pharma

HRA Pharma is a privately-held European pharmaceutical company that designs products, devices and supporting services in niche areas of health and makes them available to doctors and patients worldwide. A pioneer in emergency contraception, the company targets therapeutic gaps in the areas of reproductive health and endocrinology, and uses innovative marketing solutions and socially-conscious programs, such as contraception education in developing countries, to promote healthy management of drugs and diseases. Headquartered in Paris, France and with offices in Germany, Italy, Spain and the UK, HRA Pharma has built a strong network of R&D, manufacturing, distribution and NGO partners which enables it to satisfy critical patient needs and improve patient health in over 50 countries across the globe. Visit www.hra-pharma.com for more information.

Abstracts of the articles can be viewed at:

Ulipristal Acetate Taken 48–120 Hours After Intercourse for Emergency Contraception. Obstetrics & Gynecology. 115(2, Part 1):257-263, February 2010.

Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. The Lancet, Early Online Publication, 29 January 2010.


 

Posted: February 2010

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