NVA237 Phase II Results Presented at the European Respiratory Society Annual Meeting Show Promising Efficacy and Tolerability With Potentially Faster Onset Than Tiotropium



    TOKYO and CHIPPENHAM, England, Oct. 7 /CNW/ - Sosei Group Corporation
("Sosei"; TSE Mothers Index: 4565) and Vectura Group plc ("Vectura"; LSE:
VEC), announce results of two Phase II studies evaluating the efficacy, safety
and tolerability of NVA237 presented at the annual congress of the European
Respiratory Society (ERS) in Berlin, Germany. The new data show that NVA237
(glycopyrronium bromide), a novel inhaled long-acting muscarinic antagonist
(LAMA), provides sustained 24-hour bronchodilation in patients with
moderate-to-severe chronic obstructive pulmonary disease (COPD).
    NVA237 showed similar efficacy and duration of action to tiotropium with
potentially a more rapid onset of action. In addition, studies lasting up to
28 days showed that NVA237 was safe and well tolerated with no clinically
relevant cardiovascular findings.
    NVA237 was licensed to Novartis by Sosei and Vectura in 2005 in a deal in
which the two companies could receive up to US$ 375 million in milestones as
well as royalties on product sales.
    COPD affects 210 million people worldwide and is projected to be the
third leading cause of death by 2030. It is a progressive lung disease with
symptoms including chronic bronchitis and/or emphysema which slowly progress
and eventually lead to a largely irreversible loss of lung function. While
there is no cure, bronchodilators such as LAMAs make breathing easier by
enlarging the patient's airways, and are recognized in international
guidelines as first-line treatment for COPD.
    One of the randomized, double-blind, placebo-controlled studies compared
NVA237 (12.5, 25, 50 and 100microg once-daily) with placebo and open-label
tiotropium. In the study involving 83 patients, all doses of NVA237 showed
rapid onset of action and sustained 24-hour bronchodilation over the seven-day
treatment period.
    Clinically relevant improvements (i.e. (greater than)120mL more than
placebo) in forced expiratory volume in one second (FEV1), a standard measure
of lung function, were observed with both the 50 and 100microg doses of
NVA237. Early post-dose spirometry data suggested a more rapid onset of action
than tiotropium. During the study, NVA237 was well tolerated with a good
overall safety profile.
    The other study evaluated the safety and tolerability of NVA237 (100 and
200microg once-daily) in 250 patients during 28 days of treatment. In this
study, both doses were safe and well tolerated, with no clinically significant
changes seen in vital signs or on other cardiac monitoring. NVA237 provided
sustained 24-hour bronchodilation over the study period. The authors concluded
that NVA237 should be further evaluated for the treatment of COPD.
    The results of the latest studies are consistent with previous clinical
studies with NVA237 which demonstrated a potentially faster onset of action
than tiotropium (five minutes versus 20-30 minutes) and a good overall safety
and tolerability profile.
    Mr Shinichi Tamura, President & CEO of Sosei, said: "I am pleased that
these two trials have further confirmed the clinical profile of NVA237 in
terms of low side effects and fast onset of action and that the drug has been
deemed worthy of further study."
    Dr Chris Blackwell, Chief Executive of Vectura commented: "On the back of
these encouraging results, we now look forward to the continued progress of
NVA237, and the combination therapy, QVA149."

    
    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 a third combination product is
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 http://www.sosei.com

    About Vectura

    Vectura Group plc is a product development company focused on the
development of a range of inhaled therapies principally for the treatment of
respiratory diseases. Vectura develops products to treat respiratory diseases
such as asthma, chronic obstructive pulmonary disease (COPD) and cystic
fibrosis, a market which is forecast to double over the next ten years from
$23 billion in 2007 to $46 billion by 2017. Vectura also develops products for
non-respiratory diseases where optimised delivery via the lungs could provide
significant benefits, such as a rapid onset of action, improved efficacy and
improved tolerability compared with current therapies.
    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. The Company seeks to develop
certain programmes further through development to optimise value through
licensing at a later stage. Vectura also offers its formulation and inhalation
technologies to other pharmaceutical companies on a licensing basis where this
complements Vectura's business strategy.
    Vectura has development collaborations with several pharmaceutical
companies including Boehringer Ingelheim, Novartis and Sandoz. The acquisition
of Innovata in January 2007 brought established alliances with a number of
additional companies, such as Baxter, GlaxoSmithKline (GSK), Merck Generics
(part of Mylan Inc), UCB and Otsuka, as well as providing revenue streams,
complementary products and critical mass. For further information, please
visit Vectura's website at http://www.vectura.com

    Forward-Looking Statements

    This press release contains "forward-looking statements", including
statements about the discovery, development and commercialisation of products.
Various risks may cause Sosei's or Vectura'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 statement. 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: 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, Fax: +81-3-5210-3291; 1F London BioScience Innovation Centre,
2 Royal College Street, London, NW1 0NH, Shinichi Tamura, Chief Executive
Officer, 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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