Sosei and Vectura Announce Start of Phase II Studies of QVA149 for the Treatment of COPD



    TOKYO, Japan and CHIPPENHAM, England, Nov. 15 /CNW/ - Sosei Group
Corporation ("Sosei"; TSE Mothers Index: 4565) and Vectura Group plc
("Vectura"; LSE: VEC) announce the start, by Novartis, of a Phase II safety
study of QVA149 for the treatment of chronic obstructive pulmonary disease
(COPD). QVA149 is a combination of NVA237, a once-daily long-acting muscarinic
antagonist (LAMA) and indacaterol, a once-daily long-acting beta-2 agonist
(LABA).
    The randomised, double-blind, placebo-controlled, multi-centre study will
determine the effect of QVA149 and indacaterol on mean 24-hour heart rate in
patients with moderate to severe COPD.
    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. Indacaterol was discovered by Novartis and
is currently in Phase III trials for COPD. NDA submissions have been projected
for 2010.
    Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that
QVA149 has now entered Phase II clinical development. This once-daily
LAMA/LABA combination has the potential to be a best in class treatment."
    Dr Chris Blackwell, Chief Executive of Vectura added: "Chronic
respiratory diseases like COPD are often sub-optimally treated, and patients
don't always receive effective therapies. The market for COPD therapy is
predicted to double in size to $11 billion by 2011. The progress Novartis is
making with both NVA237 and QVA149 is therefore of interest to many."

    Notes for Editors:

    About the NVA237 licence agreement with Novartis

    Sosei and its co-development partner 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 have already received
$15 million each and will receive up to $172.5 million each for achieving
pre-agreed clinical, regulatory and commercialisation targets for both the
monotherapy and combination product. These potential milestones thus 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 may 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 2020 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 current market for COPD drug therapy is estimated to be worth around
$6 billion per annum and is forecast to grow to $11 billion by 2011 as a
result of increasing diagnosis and treatment and the growth of high value new
products.

    About Sosei

    Sosei 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 is a pulmonary drug development company focused principally on
the development of a range of inhaled therapies for the treatment of
respiratory and neurological diseases. The respiratory market is forecast to
achieve sales of $32 billion by 2011. Vectura develops products to treat
respiratory diseases such asthma, COPD and cystic fibrosis. Vectura also
develops products where optimised delivery via the lungs into the blood stream
can provide significant benefits, such as a rapid onset of action, improved
efficacy and improved tolerability compared with current therapies.
    Vectura has eight marketed products and a portfolio of drugs in clinical
and pre-clinical development, some of which have been licensed to major
pharmaceutical companies. The Company also seeks to develop certain programmes
further through development to optimise value at a later licensing 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 a broad range of
pharmaceutical companies including Boehringer Ingelheim, Novartis, and Chiesi.
The acquisition of Innovata in January 2007 brought established alliances with
a number of additional companies, such as Baxter, GSK, Merck Generics (part of
Mylan Inc), UCB and Otsuka as well providing revenue streams, complementary
products and critical mass.
    For further information, please visit Vectura's website at
http://www.vectura.com





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: hmaekawa@sosei.com, Tel:
+81-3-5210-3399; Sosei R&D Ltd: Chesterford Research Park, Saffron Walden,
CB10 1XL, England, John DAFFURN, SVP Corporate Development, E-mail:
daffurnj@sosei.com, Tel: +44(0)1799-532-350; The Trout Group: Thomas Fechtner,
Tel: (646) 378-2915; Brandon Lewis, Tel: (646) 378-2931; Vectura Group plc:
Chris Blackwell, Chief Executive, Anne Hyland, Chief Financial Officer, Julia
Wilson, Director of Investor Relations & Corporate Communications, Tel:
+44(0)1249-667700; Financial Dynamics: David Yates, Tel: +44(0)207-831-3113

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