Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237

    - Study Triggers $7.5m Milestones for Both Companies

    CHIPPENHAM, England and TOKYO, June 29 /CNW/ - Sosei Group Corporation
("Sosei"; TSE Mothers Index: 4565) and Vectura Group plc ("Vectura"; LSE: VEC)
announce the commencement of a Phase III clinical study by Novartis, with
NVA237, a once-daily, long-acting muscarinic antagonist (LAMA) for the
treatment of chronic obstructive pulmonary disease (COPD). NVA237 is a dry
powder formulation for oral inhalation of glycopyrronium bromide, a LAMA with
a rapid onset of activity. The study has now appeared on
and will be recruiting in the next few weeks when the first patient first
visit will trigger a $7.5 million milestone payment to both Sosei and Vectura.
    The trial is a randomised, double-blind, placebo-controlled,
parallel-group design, including an open-label tiotropium bromide arm, and
will assess efficacy, safety and tolerability of NVA237 in patients with COPD.
It will include approximately 1000 patients with moderate to severe COPD from
study centres across the USA, Europe and other territories. Each patient will
be randomised to receive a once-daily dose of placebo, tiotropium bromide or
50microg of NVA237 for a 52-week period. The primary endpoint of the study
will be the change from baseline in FEV1 (forced expiratory volume in one
second) over 12 weeks of treatment. A number of secondary endpoints will also
be evaluated.
    NVA237 was licensed to Novartis in April 2005 by Sosei and its
co-development partner Vectura. Novartis intends to launch NVA237 as a
once-daily monotherapy for COPD and also in combination with Novartis'
investigational once-daily, long-acting beta2-agonist (LABA) indacaterol
(QAB149), which was filed for approval with the regulatory authorities as a
monotherapy treatment for COPD at the end of 2008. The combination of NVA237
and indacaterol is known as QVA149. NDA submissions are expected to be filed
by Novartis for both NVA237 and QVA149 in 2011.
    Mr Shinichi Tamura, President & CEO of Sosei, commented:
    "This represents an important milestone in the clinical development of
NVA237 and we look forward also to the anticipated commencement of the Phase
III study for QVA149 towards the end of this year."
    Dr Chris Blackwell, Chief Executive of Vectura, added: "The Phase II
studies demonstrated that NVA237 provides sustained 24-hour bronchodilation in
patients with moderate to severe COPD. As it now enters the final stage of
clinical development before market, confidence in the product is at a new high
as we anticipate confirmation of such benefit in a large target patient

    Notes for Editors:

    About the NVA237 and QVA149 licence agreement with Novartis

    Sosei and Vectura Group plc concluded a global development and
commercialisation agreement with Novartis in April 2005 for their
collaborative product NVA237. Novartis is responsible for developing and
commercializing NVA237 both as a monotherapy and in combination with
indacaterol, its once daily, long-acting beta-2 agonist, as QVA149.
    Under the terms of the agreement, Sosei and Vectura to date have each
received $15 million and will each receive up to $172.5 million for achieving
pre-agreed clinical, regulatory and commercialisation targets for both the
monotherapy and combination product. These potential milestones total up to
$375 million. In addition, royalties on product sales will be paid for the
monotherapy and the combination product. If additional combination products
are developed by Novartis, using NVA237, further milestones and royalties will
be payable.

    About COPD

    COPD is a chronic obstruction of the airways which in the developed world
is caused primarily by smoking. Symptoms include chronic bronchitis and/or
emphysema which slowly progress and eventually lead to a largely irreversible
loss of lung function. COPD is currently the fourth most common cause of death
and by 2030 is predicted to become the third most common cause of death and
the fourth most important disability causing illness. The total financial
burden of lung disease in Europe amounts to nearly EUR102 billion with COPD
contributing almost one half of this figure. Around three-quarters of patients
with advanced COPD are unable to perform normal everyday activities. The
market for COPD drug therapy was estimated to be worth around $5.7 billion in
2007 with a compound average growth rate of 19% over the preceding 5 years.
Further significant growth can be anticipated as a result of better diagnosis
and treatment and the introduction of high value new products.

    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 Vectura

    Vectura Group plc is a product-focused Group that develops inhaled
therapies principally for the treatment of respiratory diseases. Vectura's
main products target diseases such as asthma and chronic obstructive pulmonary
disease (COPD); a growing market that is currently estimated to be worth $20
billion. Vectura also develops products for other lung pathologies and
non-respiratory diseases.
    Vectura has eight products marketed by its partners and a portfolio of
drugs in clinical and pre-clinical development, some of which have been
licensed to major pharmaceutical companies. Vectura seeks to develop certain
programmes itself where this will optimise value. Vectura's formulation and
inhalation technologies are available to other pharmaceutical companies on an
out-licensing basis where this complements Vectura's business strategy.
    Vectura has development collaborations with several pharmaceutical
companies, including Boehringer Ingelheim, Novartis, Sandoz (the generics arm
of Novartis), Baxter, GlaxoSmithKline (GSK), Mylan, UCB and Otsuka. Vectura
has been included in the FTSE 250 index since 23 March 2009.
    For further information, please visit Vectura's website at

    Forward-Looking Statements

    This press release contains "forward-looking statements", including
statements about the discovery, development and commercialisation of products.
Various risks may cause Vectura's or Sosei's actual results to differ
materially from those expressed or implied by the forward-looking statements,
including adverse results in clinical development programmes; failure to
obtain patent protection for inventions; commercial limitations imposed by
patents owned or controlled by third parties; dependence upon strategic
alliance partners to develop and commercialise products and services;
difficulties or delays in obtaining regulatory approvals to market products
and services resulting from development efforts; the requirement for
substantial funding to conduct research and development and to expand
commercialisation activities; and product initiatives by competitors. As a
result of these factors, prospective investors are cautioned not to rely on
any forward-looking statements. We disclaim any intention or obligation to
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.

For further information:

For further information: Sosei Group Corporation, Ichiban-cho FS Bldg.,
8 Ichiban-cho, Chiyoda-ku, Tokyo 102-0082 Japan, Hidetoshi TORAMI,
Representative Director, E-mail:, Tel: +81-3-5210-3399, Fax:
+81-3-5210-3291; 1F London BioScience Innovation Centre, 2 Royal College
Street, London NW1 0NH, Non OSAKABE, PA to CEO, E-mail:,
Tel: +44-20-7691-2081, Fax: +44-20-7209-2484; Vectura Group plc, Tel: + 44 (0)
1249 667700, Chris Blackwell, Chief Executive, Anne Hyland, Chief Financial
Officer, Julia Wilson, Director of Investor Relations, Financial Dynamics,
Tel: + 44(0)207-831-3113, David Yates, Ben Atwell

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