Update on NVA237 and QVA149 for Chronic Obstructive Pulmonary Disease

TOKYO, October 22 /PRNewswire-FirstCall/ -- Sosei Group Corporation
("Sosei"; TSE Mothers Index: 4565), announces that the Phase III trials with
NVA237, which commenced in June 2009, are proceeding to plan. Initiation of
Phase III studies with QVA149 is now expected to occur during 2010. Receipt
of the associated milestone payment of $7.5m is therefore expected during the
financial year to 31 March 2011.
QVA149 is a novel once-daily, dry powder, fixed dose, bronchodilator
combination of the once-daily beta2-agonist indacaterol and the long-acting
muscarinic antagonist NVA237 (glycopyrronium bromide), in development for the
treatment of chronic obstructive pulmonary disease (COPD). Novartis announced
on 25 September 2009 that indacaterol was recommended for approval in
European Union to treat patients with COPD following its regulatory
submission in late 2008. Furthermore, Novartis received a Complete Response
letter from the FDA on 16th October requesting additional information on the
dosing proposed for indacaterol.
Mr Shinichi Tamura, President and CEO of Sosei said: "Progress with Phase
III studies evaluating NVA237, and the rapid review and recommendation for
approval of indacaterol in Europe, are both encouraging with regard to the
development of QVA149. We were impressed with the positive data at the
European Respiratory Society meeting, and it continues to be our belief that
QVA149 has the potential to be the first once-daily LAMA/LABA combination
available to patients."
Notes for Editors:
About the NVA237 Licence Agreement with Novartis
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, long-acting muscarinic antagonist (LAMA) monotherapy for COPD and
also in combination with their once-daily, long-acting beta2-agonist (LABA)
indacaterol (QAB149). The combination of NVA237 and indacaterol is known as
QVA149.
NVA237 entered Phase III trials in June 2009 which triggered a
$7.5million milestone payment to both Sosei and Vectura. Under the terms of
the agreement, Sosei and Vectura 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 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 affects 210 million
people worldwide and is projected to be the third leading cause of death by
2030. Commonly caused by cigarette smoke and other harmful fumes COPD is a
progressive lung disease with symptoms including chronic bronchitis and/or
emphysema, which slowly progresses and eventually leads to a largely
irreversible loss of lung function. While there is no cure, bronchodilators
such as LABAs and LAMAs make breathing easier by enlarging the patient's
airways, and are recognised in international guidelines as an integral part
of the treatment for COPD.
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 www.sosei.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 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.
SOURCE Sosei Group Corporation

Enquiries: Sosei Group Corporation, Kojimachi Tsuruya Hachiman Bldg. 5F, 2-4
Kojimachi, Chiyoda-ku, Tokyo 102-0083 Japan, Hidetoshi Torami, Tel
+81-3-5210-3399, Fax +81-3-5210-3291, E-mail: htorami@sosei.com. 1F London
BioScience Innovation Centre, 2 Royal College Street, London NW1 0NH, Yumi
Yamamoto-Tyrrell, Manager, Finance and IR Europe, Tel +44-20-7691-2081, Fax
+44-20-7209-2484 , E-mail: yyamamoto@sosei.com