Sosei Announces Approval to Start AD 923 Phase III Studies in Europe

    TOKYO, Nov. 28 /CNW/ - Sosei Group Corporation ("Sosei"; TSE Mothers
Index: 4565), a biopharmaceutical company, today announces that it has
received approval from the UK Medicines and Healthcare products Regulatory
Agency (MHRA) for the Phase III clinical trial programme for its fentanyl
sublingual spray (AD 923), an opioid analgesic for the treatment of cancer
breakthrough pain.
    The clinical trial authorisation (CTA) covers two multi-centre pivotal
Phase III efficacy studies followed by an open label safety study. Patient
enrolment in the UK is expected to commence before the end of the year and
will be the subject of a separate announcement. Applications have been made in
other European countries and further patient recruitment will be initiated as
soon as approval is received from the relevant local regulatory body.
    This first CTA in a major European country will also trigger the receipt
of a project milestone payment under the AD 923 Licence Agreement signed with
Mundipharma in June 2006.
    Mr Shinichi Tamura, President & CEO of Sosei, said: "Receipt of our first
Phase III CTA represents an important milestone in the evolution of Sosei and
the continuing progress of the AD 923 development programme. We look forward
to enlisting our first patients in the trial".

    Notes to Editors:

    About Sosei

    Sosei Group Corporation 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 AD 923

    AD 923 is an optimised, sublingual formulation of the strong opioid
analgesic fentanyl. It has been specifically designed to provide rapid onset
of analgesia in a device that is easy to use by either the patient or their
care giver. An additional benefit is the lockout system that prevents
inadvertent overdosing. Sosei has concluded a range of studies that confirm
the potential of this novel product.
    In June 2006, Sosei entered into an agreement with Mundipharma
International Corporation Limited for the development and commercialisation of
AD 923 in Europe and other international markets, excluding North America and
Japan. Sosei is currently evaluating its commercialisation options for the
un-partnered territories.

    About Cancer Breakthrough Pain

    Cancer breakthrough pain is characterised by temporary exacerbations of
moderate to severe pain in cancer patients that "breakthrough" their
around-the-clock opioid treatments. Each episode may be spontaneous or
incidental to an activity. It is estimated that the condition is prevalent in
approximately 60% of cancer pain patients across Europe, the US and Japan,
representing a total population size of 2.3 million. Most current treatments
for cancer breakthrough pain are considered sub-optimal. The market seeks
products which have a rapid onset of action and are easy to use. The current
worldwide market for cancer breakthrough pain drug treatment is estimated to
be worth $1.5bn and represents a growing market opportunity.

For further information:

For further information: 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; Sosei R&D Ltd.: Chesterford Research
Park, Saffron Walden, CB10 1XL England, John DAFFURN, EVP Corporate
Development, E-mail:, Tel: +44-1799-532-350, Fax:
+44-1799-532-351; The Trout Group: Seth Lewis, Tel: (617)583-1308; Brandon
Lewis, Tel: (646) 378-2915

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