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Sosei Announce Start of Phase III Clinical Study With QVA149

May 10, 2010

TOKYO, May 10, 2010 /PRNewswire-FirstCall/ — Sosei Group Corporation
(“Sosei”; TSE Mothers Index: 4565) announce the commencement of the Phase III
clinical programme by Novartis, with QVA149, a once-daily, dry powder
bronchodilator for inhalation combining a fixed dose of the once-daily
beta2-agonist QAB149 (indacaterol) and the long-acting muscarinic antagonist
NVA237 (glycopyrronium bromide) for the treatment of chronic obstructive
pulmonary disease (COPD). The start of Phase III triggers a $7.5m milestone
payment to Sosei.

The programme commences with two 52 week studies. The first trial, a
randomised, double-blind, parallel-group design, will assess as its primary
outcome measure the superiority of QVA149 over NVA237 alone in the rate of
exacerbations in 1,998 patients with severe or very severe COPD (GOLD stages
III or IV) from study centres across the USA, Europe and other territories.
Secondary endpoints include time to first exacerbation together with safety
and tolerability. The second trial has a randomised, double-blind,
parallel-group, placebo controlled design and will assess the long term
safety and tolerability of QVA149 in 339 patients with moderate to severe
COPD. FEV1 (forced expiratory volume in one second) is a secondary outcome
measure. In both trials patients will be randomised to receive a once-daily
dose of either the combination product or the comparator from a single dose
dry powder inhaler for a 52-week period.

NVA237 was licensed to Novartis by Sosei and its co-development partner
Vectura Group plc in a 2005 deal in which the two companies could receive up
to US$375 million in milestones as well as royalties on product sales. Phase
III trials on NVA237 commenced in June 2009 and Novartis has stated that it
expects to file for approval in 2011. Novartis received European regulatory
approval for indacaterol (Onbrez(R) Breezhaler(R) – indacaterol maleate) in
November 2009 and launched the product in Germany in December 2009 and in
Ireland and Denmark in March 2010 and have confirmed that they are on track
to file the additional data requested by the Food and Drug Administration
(FDA) in the second half of 2010.

Mr Shinichi Tamura, President & CEO of Sosei, commented:

“The data from the two Phase II QVA149 studies presented at the annual
congress of the European Respiratory Society (ERS) in Vienna in September
2009
were very encouraging and demonstrated the benefit of combining two
potent bronchodilators in a convenient once-daily therapy with an attractive
efficacy and safety profile. This is the first once daily LAMA/LABA
combination product to enter Phase III trials and, with an anticipated filing
date of 2012, could provide an important future addition to the available
treatment options for COPD.”

Notes for Editors:

About the NVA237 Licence Agreement with Novartis

Sosei and Vectura concluded a global development and commercialisation
agreement with Novartis in April 2005 for their collaborative product NVA237.
Novartis is responsible for developing and commercialising NVA237 both as a
monotherapy and in combination with QAB149 (indacaterol), its once-daily,
long-acting beta2-agonist, as QVA149.

NVA237 entered Phase III trials in June 2009 which triggered an earlier
milestone payment of $7.5m to each company. Novartis received European
regulatory approval for indacaterol (Onbrez(R) Breezhaler(R) – indacaterol
maleate) in November 2009 and launched the product in Germany in December
2009
and in Ireland and Denmark in March 2010 and have confirmed that they
are on track to file the additional data requested by the Food and Drug
Administration (FDA) in the second half of 2010.

Under the terms of the agreement, Sosei and Vectura will receive total
milestones of up to $375 million for the achievement of pre-agreed clinical,
regulatory and commercialisation targets for both the monotherapy and
combination product. 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. It 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 LAMAs and LABAs 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 http://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


Source: newswire



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