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ASKA Pharmaceutical and HRA Pharma Announce Exclusive Licensing Agreement for ellaOne(R) in Japan


5/19/2011 10:56:48 AM

Tokyo, Japan and Paris, France – May 19th, 2011 – ASKA Pharmaceutical Co., LTD and HRA Pharma have announced the conclusion of exclusive licensing agreements for ASKA Pharmaceutical to develop and market ulipristal acetate in Japan in response to multiple women’s reproductive health issues, in particular emergency contraception.

Ulipristal acetate for emergency contraception, known as ellaOne® in Europe as well as ella® in the United States, has undergone an exhaustive program of trials in both the USA and Europe. HRA Pharma partnered with the American National Institute of Health first beginning its work to develop the emergency contraceptive pill nearly 12 years ago. Since that time it has undergone pre clinical and full clinical tests in over 4,000 women. The European Medicines Agency (EMA) approved ellaOne® in 2009 following its submission and the US regulatory authorities granted its license mid of last year. It is now available to women in the UK, France, Germany, and 23 other major European countries.

Ulipristal acetate is a first-in-class, orally active selective progesterone receptor modulator that reversibly blocks the progesterone receptors in targeted tissues. 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 existing levonorgestrel-based methods.

The European Medicines Agency review of the company’s recent pivotal clinical efficacy data in 2010 concluded that ellaOne® is significantly more effective than levonorgestrel in reducing pregnancy risk. ellaOne® is the first and only oral emergency contraceptive indicated for 5 days and this outcome officially recognises ellaOne’s unique product profile as the most effective alternative for oral emergency contraception.

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 Japan will now have access to ellaOne®. HRA Pharma is keen to partner with like-minded pharmaceutical companies and we look forward to working with ASKA Pharmaceutical. They are well placed to help successfully realise the full therapeutic potential of molecules such as ulipristal acetate for various gynecological indications.”

Dr Yamaguchi, CEO of ASKA Pharmaceutical, said: “We are delighted to be entering into a licensing agreement with HRA Pharma and foresee substantial market potential for ulipristal acetate in Japan. We are expecting ellaOne® to follow on NorLevo® (levonorgestrel) another product related to emergency contraception to which ASKA also has the marketing rights in Japan”

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.

About ASKA

ASKA Pharmaceutical Co., Ltd. located in Tokyo, Japan, is a research and development (R&D) oriented company, which contributes to the society by developing and providing innovative pharmaceutical products with concentrating its management resources to the specific therapeutic areas. Additional information on ASKA Pharmaceutical Co., Ltd. is available through its corporate website http://www.aska-pharma.co.jp/english/index.html.


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