Sosei Group Corporation: First in Class Once-Daily Dual Bronchodilator Ultibro Inhalation Capsules (QVA149) Approved for the

  Sosei Group Corporation:First in Class Once-Daily Dual Bronchodilator
  Ultibro Inhalation Capsules (QVA149) Approved for the Treatment of COPD in
  Japan

  *Once-daily Ultibro^® Inhalation Capsules (QVA149) (glycopyrronium /
    indacaterol), delivered through the Breezhaler^® device, approved for
    relief of various symptoms due to airway obstruction in COPD
  *IGNITE data showed QVA149 significantly improved lung function and
    patient-reported outcomes including breathlessness and rescue medication
    use, compared to current standards of care^1-3
  *QVA149 significantly reduced the rate of all COPD exacerbations compared
    to glycopyrronium 50 mcg and open-label tiotropium 18 mcg^3

Business Wire

TOKYO -- September 20, 2013

Sosei Group Corporation (“Sosei”)(TOKYO:4565) confirms that the Japanese
Ministry of Health, Labour and Welfare (MHLW) approved once-daily Ultibro^®
Inhalation Capsules (glycopyrronium 50 mcg / indacaterol 110 mcg), delivered
through the Breezhaler^® device, for relief of various symptoms due to airway
obstruction in chronic obstructive pulmonary disease (COPD). Ultibro
Inhalation Capsules were developed by Novartis under the name of QVA149 and 
will be available to the 5.3 million Japanese patients who may be living with
COPD^4. The approval triggers a $2.5m milestone payment to Sosei.

Dual bronchodilation with QVA149 is expected to set a new standard of care in
COPD by combining the proven efficacy and safety benefits of two established
Novartis COPD treatments, the LABA*, Onbrez^® Inhalation Capsules
(indacaterol), and the LAMA**, Seebri^® Inhalation Capsules (glycopyrronium
bromide). Both these components are delivered through the Breezhaler^® device,
as is QVA149, and are widely available in many countries around the world
including Japan.

The efficacy and safety of QVA149 is supported by the comprehensive IGNITE
Phase III clinical trial program, one of the largest international trial
programs in COPD comprising 11 studies in total with more than 10,000 patients
from 52 countries^1-3,5-14.

From the eight IGNITE studies which completed in 2012^1-3,5-9, data showed
that QVA149 significantly improved lung function versus several current
standard treatments^1,3,5 and showed significant symptomatic improvements
versus placebo in breathlessness, exercise tolerance, rescue medication use
and health-related quality of life^1,2,5. QVA149 also demonstrated
statistically significant symptomatic improvements in breathlessness, rescue
medication use and health-related quality of life compared to open-label (OL)
tiotropium 18 mcg^1. The rate of all COPD exacerbations (mild, moderate and
severe) was significantly improved with QVA149 compared to glycopyrronium 50
mcg and OL tiotropium 18 mcg^3.

In clinical studies, QVA149 demonstrated an acceptable safety profile with no
meaningful differences between the treatment groups (placebo, indacaterol 150
mcg, glycopyrronium 50 mcg, OL tiotropium 18 mcg, salmeterol / fluticasone
(SFC) 50 mcg / 500 mcg) in the incidence of adverse and serious adverse
events^1-3,5. The safety profile was characterized by typical anticholinergic
and beta-adrenergic effects related to the individual components of the
combination^1-3,5-9.

In July, the European Medicines Agency’s Committee for Medicinal Products for
Human Use (CHMP) adopted a positive opinion for approval of QVA149. US
submission is anticipated at the end of 2014.

Ultibro^®, ^ Seebri^®, Onbrez^® and Breezhaler^® are registered trademarks of
Novartis AG.

* a long-acting beta[2]-adrenergic agonist, ** a long-acting muscarinic
antagonist

About QVA149
QVA149 is an inhaled, once-daily, fixed-dose combination of glycopyrronium
bromide and indacaterol maleate. QVA149 was investigated for the treatment of
COPD in the Phase III IGNITE clinical trial program. IGNITE is one of the
largest international clinical trial programs in COPD comprising 11 studies in
total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON,
RADIATE, LANTERN, FLAME) with more than 10,000* patients across 52
countries^1-3,5-14. The first eight studies (ILLUMINATE, SHINE, BRIGHT,
ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON) completed in 2012^1-3,5-9. The studies
are designed to investigate the efficacy (lung function, exercise endurance,
exacerbations, shortness of breath and quality of life), safety and
tolerability, in patients treated with QVA149^1-3,5-12.

Results from the Phase III IGNITE trials ^ demonstrated statistically
significant improvements in bronchodilation with QVA149 versus comparator
treatments^1,3,5 widely used as current standards of care. Data showed that
QVA149 significantly improved bronchodilation compared to OL tiotropium 18
mcg, fixed dose combination SFC 50 mcg/500 mcg, indacaterol maleate 150 mcg,
glycopyrronium 50 mcg and placebo providing a rapid onset within five minutes,
and sustained bronchodilation during a 24 hour period which was maintained for
up to 26 weeks^2,5. In the IGNITE Phase III trial program, QVA149 also showed
symptomatic improvements versus placebo in COPD patients^1,2,5. These
symptomatic improvements included shortness of breath, exercise tolerance,
rescue medication use and health-related quality of life^1,2,5. QVA149 also
significantly improved the rate of all COPD exacerbations (mild, moderate and
severe) compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg^3.

* Total refers to all 11 IGNITE studies.

About Seebri^® Breezhaler^®
Once-daily Seebri^® Breezhaler^® / Seebri^® Inhalation Capsules
(glycopyrronium bromide) are a novel inhaled long-acting muscarinic antagonist
(LAMA; also referred to as a long-acting anticholinergic) indicated as a
maintenance bronchodilator treatment to relieve symptoms in adult patients
with COPD^15. Glycopyrronium bromide was exclusively licensed to Novartis in
April 2005 by Sosei and its co-development partner Vectura. In Phase III
studies (GLOW 1, 2 and 3), once-daily glycopyrronium 50 mcg demonstrated rapid
improvements in lung function after first dose on Day 1 which was sustained
for 24 hours and maintained over the 52 week study period compared with
placebo^16-18. Glycopyrronium 50 mcg also significantly improved shortness of
breath, health-related quality of life, exacerbation risk, and exercise
endurance versus placebo^16-18. Glycopyrronium is approved in the EU, Japan,
Switzerland, Canada, Australia and a number of other countries.

All Novartis inhaled COPD portfolio products are being developed for delivery
via a single-dose dry powder inhaler (SDDPI) called the Breezhaler^® device
which has low air flow resistance, making it suitable for patients with
airflow limitation^19. The Breezhaler^® device allows patients to hear, feel
and see that they have taken the full dose correctly^15.

About COPD
COPD is a chronic, progressive lung disease that is commonly caused by tobacco
smoking, air pollution or occupational exposure, and results in airflow
obstruction and debilitating bouts of breathlessness^20. Although the latest
figures show only 173,000 people have been diagnosed with COPD in Japan^21,
epidemiological data suggest that the total number of patients could be as
high as 5.3 million^4. There are concerns that the number of patients could
grow in Japan where smoking rates are high and many people are starting to
smoke at an increasingly early age.

About Sosei
Sosei is an international biopharmaceutical company anchored in Japan with a
global reach. It practises a reduced risk business model by acquiring
compounds from, and bringing compounds into, Japan through exploitation of its
unique position within global markets.

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.

References

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Contact:

Sosei Group Corporation
Tokyo Office
Milica STOJKOVIC,
Investor Relations
+81-(0)3-5210-3399
mstojkovic@sosei.com
or
London Office
Kathryn LYDON, PA to CEO & Corporate Communication
+44-(0)20-7691-0983
klydon@sosei.com