HRA Pharma Granted European Marketing Authorization For EllaOne(R) - Next Generation Emergency Contraceptive

Main Category: Sexual Health / STDs
Article Date: 29 May 2009 - 4:00 PDT

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HRA Pharma, a privately-held, European pharmaceutical company that designs products, devices and supporting services in reproductive health and endocrinology, announced today that ellaOne(R) (ulipristal acetate), its next generation emergency contraceptive, has been granted marketing authorization by the European Commission. The unanimous decision by all member states enables HRA Pharma to begin marketing ellaOne throughout the European Union, making it the only approved product to have been specifically designed and developed for use as an emergency contraceptive.

"This milestone is testimony to emergency contraception as a real therapeutic need and to the potential of ulipristal acetate as a viable solution," said Dr. Erin Gainer, CEO of HRA Pharma. "Our goal is to ensure that ellaOne is available to the millions of women who might need it, and we plan to put our sales and marketing infrastructure as well as our privileged partnerships into action to accompany this roll-out."

The European Commission's marketing authorization follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency in March 2009. ellaOne will be progressively launched and marketed throughout the entire European Union, directly by HRA Pharma in the UK, Germany, Italy and France and via partner companies elsewhere.

Current hormonal emergency contraception (based on levonorgestrel) is very well tolerated, but its efficacy decreases significantly as time elapses after unprotected intercourse. Based on the new chemical entity ulipristal acetate, ellaOne has been shown to have sustained efficacy and has thus been approved for use up to five days after unprotected intercourse, without compromising the safety or tolerability profile of levonorgestrel.

HRA Pharma has long been a leader in emergency contraception, providing solutions to unmet needs for millions of women in over 50 countries since the launch of its pioneering product NorLevo. The company plans to file for marketing approvals in countries worldwide under the trademarks ellaOne and ella, and continues to research pharmaceutical developments in the field of reproductive health that are better adapted to women's lifestyles. HRA Pharma is currently developing its compound ulipristal acetate for other indications outside of emergency contraception, including uterine fibroids.

Source
HRA Pharma