Sosei Announces Start of AD 923 Phase III Studies in Europe

    TOKYO, Feb. 12 /CNW/ - Sosei Group Corporation ("Sosei"; TSE Mothers
Index: 4565), a biopharmaceutical company, today announces that it has
commenced Phase III studies for its fentanyl sublingual spray (AD 923), an
opioid analgesic for the treatment of cancer breakthrough pain.
    The trial is a multi-centre, randomised, double-blind, double-dummy,
crossover study to evaluate the safety and efficacy of AD 923 against an
active comparator (morphine sulphate immediate release (MSIR)) for the
treatment of breakthrough pain in patients with malignancies. The primary
endpoint is the well established summary of pain intensity difference (SPID)
measure over the first 30 minutes from initial dosing.
    Overall, the European Phase III programme will involve some 300 patients
in two studies, involving an active comparator, across 10 European countries.
These will then be followed by a single combined open label study to assess
the long term effectiveness, safety and tolerability of AD 923.
    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.
    Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that
we are able to announce the start of Phase III studies. AD 923 has been
optimised to meet the well recognised need for a safe and effective method of
delivering fentanyl for the rapid relief of breakthrough pain in malignant and
also non-malignant conditions."

    Notes for 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 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. The recent European Pain in Cancer Survey (EPIC)
results reveal that cancer related pain is widespread in Europe, with one in
two (56%) cancer patients enduring moderate to severe pain (n=5,084). The
second, detailed phase of the survey reveals that cancer breakthrough pain or
inadequate pain relief is a common problem for many patients - 63% of patients
in Europe prescribed analgesia, report that they are affected by breakthrough
pain (n=441). It also highlights that breakthrough pain can be a frequent
occurrence - 26% experiencing it at least once a day (n=279). For further
information please visit
    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

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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