AD 923 Commences Phase 1 Clinical Development in the USA

    TOKYO, Japan, March 5 /CNW/ - Sosei Group Corporation ("Sosei"; TSE
Mothers Index: 4565), a biopharmaceutical company, today announces that AD
923, a novel sublingual fentanyl spray for the treatment of cancer
breakthrough pain, has entered into a Phase I comparative pharmacokinetic
study in the USA under an IND regulatory submission.
    The trial is a single centre, open-label, single dose, cross-over study
to investigate the comparative pharmacokinetics of AD923 against intravenous
and oral transmucosal formulations of fentanyl in 24 healthy human volunteers.
    Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that
we have been able to announce the progression of the AD 923 development
programme into the USA. There is a major requirement for a simple and
manageable method of providing immediate-release fentanyl for the rapid relief
of breakthrough pain which AD 923 has been optimised to deliver."

    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 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 overdosage. 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 are 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, SVP Corporate
Development, E-mail:, Tel: +44-(0)1799-532-350 Fax:
+44-(0)1799-532-351; Financial Dynamics Tel: +44-(0)207-831-3113, Julia
Phillips; The Trout Group: Thomas Fechtner Tel: (646) 378-2915; Brandon Lewis
Tel: (646) 378-2931

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