TOKYO, October 22 /PRNewswire-FirstCall/ -- Sosei Group Corporation , the biopharmaceutical company, today announced that Sosei Co., Ltd., its wholly owned Japanese subsidiary, has entered into a binding letter of agreement with ASKA Pharmaceuticals Co., Ltd. for the commercialization of the emergency contraceptive pill SOH-075 (NorLevo(R)).
NorLevo(R) is an oral emergency contraceptive "morning after pill" which is used to prevent unwanted pregnancy after unprotected intercourse. NorLevo(R) contains only levonorgestrel as an active ingredient. The dosing is started within 72 hours after unprotected sexual intercourse. NorLevo(R) was first launched in Europe in 1999 and is currently approved in some 60 countries; the product being both safe and effective as an oral emergency contraceptive for post-coital use. Sosei acquired the exclusive distribution rights to the product in Japan from HRA Pharma. The Phase III study was completed in October 2008, and filing of the NDA in Japan is planned for the first half of 2009.
Under the terms of the agreement Sosei will be responsible for Development and registration and ASKA for sales and marketing. A joint committee will be established to oversee all the commercialisation activities. As part of the deal structure, Sosei will receive upfront and milestone payments as well as a significant portion of net sales. ASKA will also acquire shares of Sosei.
With its current product line-up, which includes oral contraceptive pills and infertility drugs, ASKA has taken a significant share of the Japanese obstetric and gynaecologic market. Now, as the anticipated marketing of a menopause disorder patch at the beginning of 2009 approaches, ASKA is focusing on further enhancement of its position in these therapeutic areas.
The agreement underscores Sosei's wish to make a contribution to women's health in Japan.
Notes to Editors
ECP is necessary for women who may be concerned about the possibility of an unwanted pregnancy following unprotected intercourse. Two large multinational studies, aiming to test a 12-24h regimen (Lancet, 1999) and a single administration (Lancet, 2002), both performed by the World Health Organisation (WHO) demonstrated that levonorgestrel mono therapy, such as NorLevo(R), was safe and more effective than the Yuzpe method (ethinyl estradiol and levonorgestrel), a traditional emergency contraception method used since 1977. Levonorgestrel mono therapy for emergency contraception is listed as an essential drug by the WHO.
Sosei Group is a leading international biopharmaceutical company with significant expertise in product discovery and development. It has established a reduced risk business model primarily upon identifying new uses for established drugs and exploiting its unique position within Japanese, European and North American pharmaceutical markets by acquiring compounds from, and bringing compounds into, Japan.
For further information about Sosei, please visit http://www.sosei.com
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