Sosei Announces Completion of Phase II Trial of AD 337 in Fibromyalgia Syndrome



    TOKYO, Sept. 18 /CNW/ - Sosei Group Corporation ("Sosei"; TSE Mothers
Index: 4565), the biopharmaceutical company, today announces that AD 337, an
enantiomer of an approved, centrally acting, non-opioid, analgesic, has
completed a Phase II proof of principle trial for the treatment of
fibromyalgia syndrome (FMS).
    The trial, a multi-centre, randomised, double-blind, placebo controlled,
parallel group exploratory study, investigated the efficacy, safety and
tolerability of AD 337 in the treatment of fibromyalgia in female subjects. In
total, the trial enrolled 103 patients across 18 centres in the UK and
Australia with the primary study endpoint being the difference in the
Fibromyalgia Impact Questionnaire (FIQ) score, between active and placebo,
after 4 weeks of treatment.
    Results show that the study did not achieve a statistically significant
outcome in its primary endpoint at 4 weeks. However statistical significance
in FIQ was achieved at the 1 week time point and positive trends were seen
throughout the study. In addition statistically significant measures in other
efficacy assessments such as the Short Form McGill Pain Questionnaire and the
Fibromyalgia Health Assessment Questionnaire (FHAQ) were seen at early time
points. On balance it is concluded that AD 337 has some potential in the
treatment of fibromyalgia syndrome.
    AD 337 was well tolerated and there were no clinically significant
changes in vital signs, biochemistry, haematology and cardiovascular
parameters.
    Commenting on these results Shinichi Tamura, CEO, said "This proof of
principle study with an unoptimised formulation and dosing schedule and
limited to four weeks in duration has demonstrated a degree of activity. Sosei
will be evaluating these results to determine its approach to the possible
further development of AD 337 in FMS and other potential indications."

    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 http://www.sosei.com.

    About Fibromyalgia

    Fibromyalgia syndrome predominantly affects women between the ages of 35
and 60 with an estimated prevalence of 2% in the USA. The disease is
characterised by widespread musculoskeletal pain that presents with a number
of co-morbidities including fatigue, sleep disturbance and depression. The
aetiology of the syndrome is not well understood but serotonin (5-HT) and
noradrenalin (NA) dysfunction is believed to be a contributory factor. To date
only one drug, Lyrica (pregabalin) is specifically indicated for FMS and
approval in the USA was only granted in June 2007. Accordingly, therapy
continues to be based on a variety of treatments used to deal with various
fibromyalgia symptoms.
    The global market for such treatments is currently worth some $350m and
is expected to grow to around $1.7 billion in the next 10 years as further new
therapeutic options specifically indicated for fibromyalgia become available.





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; Sosei R&D Ltd, Chesterford Research Park, Saffron Walden,
CB10 1XL England; John Daffurn, EVP Corporate Development, E-mail:
daffurnj@sosei.com, Tel: +44-(0)1799-532-350; Financial Dynamics, Julia
Phillips, Tel: +44-(0)207-831-3113; The Trout Group, Thomas Fechtner, Tel:
(646) 378-2915, Brandon Lewis, Tel: (646) 378-2931

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