Sosei Agrees Terms With ASKA for Commercialisation of SOH-075 (NorLevo(R))



    TOKYO, Oct. 22 /CNW/ - Sosei Group Corporation ("Sosei"; TSE Mothers
Index: 4565), 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. ("ASKA", TSE First Section
Index: 4514) 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

    levonorgestrel

    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.

    About Sosei

    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




For further information:

For further information: Enquiries: Sosei Group Corporation: Ichiban-cho
FS Bldg., 8 Ichiban-cho, Chiyoda-ku, Tokyo 102-0082 Japan, Hiroki MAEKAWA,
Representative Executive Officer, E-mail: hmaekawa@sosei.com, Tel:
+81-3-5210-3399, Fax: +81-3-5210-3291. 1F London BioScience Innovation Centre,
2 Royal College Street, London NW1 0NH, Non Osakabe, PA to CEO, E-mail:
nosakabe@sosei.com, Tel: +44-20-7691-2081, Fax: +44-20-7209-2484

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