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HRA Pharma and Hyundai Pharm First Launch of ellaOne(R) in Asia  
9/20/2011 10:37:19 AM

Seoul, South Korea and Paris, France – September 20, 2011 – HRA Pharma and Hyundai Pharm announced the recent launch of ellaOne® (ulipristal acetate) in South Korea, which becomes the first Asian country to have access to this new generation of emergency contraception (EC).

Heralded as the next generation of oral emergency contraception, ellaOne is a prescription-only product indicated for use within 120 hours (five days) of unprotected intercourse or a known or suspected contraceptive failure. The product has a unique profile making it a valuable alternative to existing EC methods.

An exhaustive development program, conducted in both the United States (US) and Europe with over 4,000 women, has demonstrated the product’s efficacy up to five days after unprotected intercourse while its safety and tolerability profile remains comparable to that of existing levonorgestrel-based methods. Moreover, a review of HRA Pharma’s pivotal clinical efficacy data by the European Medicines Agency has concluded that ulipristal acetate, the active ingredient of ellaOne, is significantly more effective than levonorgestrel in reducing pregnancy risk (1).

The European Medicines Agency (EMA) approved ellaOne in 2009 and the US Food and Drug Administration (FDA) granted its license in 2010. The product is now available in the United States and Europe under the brand names ella® and ellaOne® respectively. The product’s global roll-out continues with the aim of providing women worldwide with enhanced access to the newest form of emergency contraceptive.

Erin Gainer, CEO of HRA Pharma, said: “Our corporate mission is to make our products widely available on a worldwide basis and we are delighted that women in South Korea will now have access to ellaOne. HRA Pharma has been working with Hyundai Pharm to provide emergency contraception to South Korea for many years, celebrating a decade of access for women in 2012, and we are pleased to be marking this with the introduction of the next generation of emergency contraception.”

Chang-Hyun Yoon, President of Hyundai Pharm added, “We are delighted to be launching ellaOne in partnership with HRA Pharma and are expecting the product to follow on from the success of NorLevo® (levonorgestrel) which has been available here for almost ten years. We foresee substantial market potential for ellaOne in South Korea and are committed to working closely with all our doctors to make it available to as many women in need as possible”.

References

1.-ellaOne: EPAR - Product Information Last updated: 23/07/2010

About emergency contraception

Emergency contraception refers to back-up methods for contraceptive emergencies which women can use within the first few days after unprotected intercourse to prevent an unwanted pregnancy. Emergency contraceptives are not suitable for regular use

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. The company targets therapeutic gaps in the areas of reproductive health and endocrinology, and uses innovative marketing solutions and socially-conscious programmes, such as contraception education in developing countries, to promote healthy management of drugs and diseases. Headquartered in Paris, France and with offices throughout Europe, 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.


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