Sosei Announces Completion of Phase III Trial for NorLevo(R)

    TOKYO, July 10 /CNW/ - Sosei Group Corporation ("Sosei"; TSE Mothers
Index: 4565), the biopharmaceutical company, today announced the completion of
a Japanese Phase III clinical trial for the emergency contraceptive pill (ECP)
SOH-075 (NorLevo(R)). Sosei acquired the exclusive distribution rights to the
product in Japan from HRA Pharma.
    The clinical study was designed to evaluate the safety and prevented
pregnancy rate of SOH-075 in Japanese adult female subjects who require
emergency contraception. No serious adverse events were reported during the
    Further announcement will be made when all study results are fully
    NorLevo(R) is an oral emergency contraceptive "morning after pill" which
is used to prevent 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 well-tolerated and effective as an oral emergency
contraceptive for post-coital use.
    "We are delighted to announce the completion of Phase III trial of
SOH-075, which will be the first ECP to be introduced into Japan. We believe
that this product will meet one of the needs of Japanese women and that the
trial will confirm that NorLevo(R) is as safe and effective in this population
as has already been demonstrated in other countries," said Mr Shinichi Tamura,
Chief Executive Officer of Sosei.
    Andre Ulmann, CEO of HRA Pharma added: "We're very proud of reaching this
important milestone in Japan. We hope that, access to emergency contraception
will benefit Japanese women and families by improving reproductive health."

    Editor's notes:


    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 well-tolerated 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

    About HRA Pharma

    HRA Pharma creates innovative medicines and products for women's and
reproductive health, endocrine diseases, and cell-based therapies. The Company
discovers, develops and markets its own products and licenses-in third party
products as well. The company markets its products in more than 50 countries
either through its own sales force or through a network of distributors and
    For further information please visit the website at

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:, Tel:
+81-3-5210-3399, Fax: +81-3-5210-3291; 1F London BioScience Innovation Centre,
2 Royal College Street, London, NW1 0NH, Tina HARBIGE, PA to CEO, E-mail:, Tel: +44-20-7691-2081 Fax: +44-20-7209-2484

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