First in Class Once-Daily Dual Bronchodilator Ultibro® Breezhaler® (QVA149) Approved for the Treatment of COPD in Europe

  First in Class Once-Daily Dual Bronchodilator Ultibro® Breezhaler® (QVA149)
  Approved for the Treatment of COPD in Europe

  *Ultibro^® Breezhaler^® (QVA149) is the first once-daily dual
    bronchodilator to gain European Commission approval as a maintenance
    bronchodilator treatment to relieve symptoms in adult patients with COPD
  *Pivotal Phase III 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
  *COPD is a progressive disease affecting up to 10% of adults across
    Europe^4 and is projected to be the third leading cause of death by 2020^5

Business Wire

TOKYO -- September 23, 2013

Sosei Group Corporation (“Sosei”)(TOKYO:4565) confirms the information
released today by Novartis announcing that the European Commission approved
once-daily Ultibro^® Breezhaler^® (indacaterol 85 mcg / glycopyrronium 43 mcg)
as a maintenance bronchodilator treatment to relieve symptoms in adult
patients with chronic obstructive pulmonary disease (COPD). Ultibro^®
Breezhaler^® was developed under the name QVA149. The approval triggers a $10m
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^® Breezhaler^® (indacaterol), and
the LAMA**, Seebri^® Breezhaler^® (glycopyrronium bromide). Both these
components are delivered through the Breezhaler^® inhalation device, as is
QVA149, and are widely available in many countries around the world.

Last week, QVA149 was approved also in Japan and US submission is anticipated
at the end of 2014.

The approval of QVA149 was based on 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^1-3,6-15. From the eight IGNITE studies which completed in 2012^1-3,
6-10, data showed that QVA149 significantly improved lung function versus
several current standard treatments^1-3,6 and showed significant symptomatic
improvements versus placebo in breathlessness, exercise tolerance, rescue
medication use and health-related quality of life^1,2,6. 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^1-3,6. The safety profile was characterized by typical anticholinergic
and beta-adrenergic effects related to the individual components of the
combination^1-3,6-10.

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

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

About Ultibro^®

Ultibro^® Breezhaler^® (indacaterol / glycopyrronium) is an inhaled,
once-daily, fixed-dose combination of the LAMA, glycopyrronium bromide and the
LABA, indacaterol maleate and was developed under the name QVA149. QVA149 was
investigated for the treatment of COPD in the Phase III IGNITE clinical trial
program. IGNITE was 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^1-3,6-15. The first eight studies (ILLUMINATE,
SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON) completed in
2012^1-3,6-10. The studies were designed to investigate efficacy (lung
function, exercise endurance, exacerbations, shortness of breath and quality
of life), safety and tolerability of patients treated with Ultibro^®
Breezhaler^®1-3,6-13.

Results from the Phase III IGNITE trials have demonstrated statistically
significant improvements in bronchodilation with QVA149 versus several
treatments^1-3,6 widely used as current standards of care. Data showed that
QVA149 significantly improved lung function 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 of action within
five minutes, and sustained bronchodilation during a 24 hour period which was
maintained for up to 26 weeks^2,6. In the IGNITE phase III trial program,
QVA149 also showed symptomatic improvements versus placebo in COPD
patients^1,2,6. These symptomatic improvements included breathlessness,
exercise tolerance, rescue medication use and health-related quality of
life^1,2,6. 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^®

Seebri^® Breezhaler^® (glycopyrronium bromide) is a once-daily 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^16. Glycopyrronium bromide was
exclusively licensed to Novartis in April 2005 by Vectura and its
co-development partner Sosei. 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 were sustained for 24 hours and
maintained over the 52 week study period compared with placebo^17-19.
Glycopyrronium bromide 50 mcg also significantly improved shortness of breath,
health-related quality of life, exacerbation risk, and exercise endurance
versus placebo^17-19. Seebri^® Breezhaler^® 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^20. The Breezhaler^® device allows patients to hear, feel
and see that they have taken the full dose correctly^16.

About COPD

COPD is a progressive life-threatening disease that makes it hard to breathe,
with symptoms that have a destructive impact on patients’ function and quality
of life^21. It affects an estimated 210 million people worldwide^5 and is
projected to be the third leading cause of death by 2020^21. COPD is often
considered to be a disease of later years, but estimates suggest that 50% of
those with COPD are now less than 65 years old, resulting in increases in
absenteeism, premature retirement^22 and reductions in workforce
participation^22,23.

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:

1. Bateman ED, Ferguson GT, Barnes N, et al. Dual bronchodilation with QVA149
versus single bronchodilator therapy: the SHINE study. European Respiratory
Journal [Published on May 30 2013]. doi:
http://dx.doi.org/10.1183/09031936.00200212. [Accessed 12 September 2013].

2. Vogelmeier C et al. Efficacy and safety of once-daily QVA149 compared with
twice-daily salmeterol/fluticasone in patients with COPD (ILLUMINATE): a
randomised, double-blind, parallel group study. Lancet Respiratory Medicine.
2013;1(1): 51-60.

3. Wedzicha JA et al. Analysis of Chronic Obstructive Pulmonary Disease
Exacerbations with the Dual Bronchodilator QVA149 Compared with Glycopyrronium
and Tiotropium (SPARK): a Randomized, Double-blind, Parallel-group Study.
Lancet Respiratory Medicine 2013;1(3): 199-209.

4. European Federation of Allergy and Airways Diseases Patients Associations.
Chronic Obstructive Pulmonary Disease. Available at:
http://www.efanet.org/wp-content/uploads/2012/07/EFACOPDBook.pdf. [Accessed 18
September 2013].

5. Global Alliance Against Chronic Respiratory Diseases (GARD). Global
surveillance, prevention and control of chronic respiratory diseases: a
comprehensive approach. Available at:
http://www.who.int/gard/publications/GARD_Manual/en/. [Accessed 18 September
2013].

6. Beeh K et al. QVA149 once daily improves exercise tolerance and lung
function in patients with COPD: the BRIGHT study. Thorax. 2012;67(2) A147.

7. Dahl R et al. Safety and efficacy of dual bronchodilation with QVA149 in
COPD patients: the ENLIGHTEN study. Respiratory Medicine Journal
2013;107:1558-1567.

8. Mahler D et al. Superior lung function with once-daily QVA149 translates
into improvements in patient reported breathlessness compared with placebo and
tiotropium in COPD patients: the BLAZE study. [ATS abstract 45308; Session
C20; Date: May 21, 2013 Time: 8:15-10:45].

9. ClinicalTrials.gov, n.d. Long Term Safety and Tolerability of QVA149 Versus
Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease
(COPD) (ARISE). [Online] Available at:
http://www.clinicaltrials.gov/ct2/show/NCT01285492?term=%28ARISE%29&rank=4.
[Accessed 18 September 2013].

10. ClinicalTrials.gov, n.d. Comparison of Safety and Efficacy of the
Combination Product QVA149A Against the Concurrent Administration of the
Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive
Pulmonary Disease (COPD) (BEACON). [Online]
Available at: www.clinicaltrials.gov/ct2/show/NCT01529632?term=BEACON&rank=6.
[Accessed 18 September 2013].

11. ClinicalTrials.gov, n.d. Comparison of Long-term Safety of the Combination
Product QVA149A Against Placebo and Standard of Care Treatment in Chronic
Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow
Limitation (RADIATE). [Online] Available at:
www.clinicaltrials.gov/ct2/show/NCT01610037?term=GLISTEN&rank=1. [Accessed 18
September 2013].

12. ClinicalTrials.gov, n.d. A 26-week Treatment Randomized, Double-blind,
Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and
Tolerability of QVA149 (Indacaterol / Glycopyrronium Bromide) Compared to
Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive
Pulmonary Disease. (LANTERN) [Online]. Available at:
www.clinicaltrials.gov/ct2/show/NCT01709903?id=01709903&rank=1. [Accessed 18
September 2013].

13. ClinicalTrials.gov, n.d. A 52-week Treatment, Multi-center, Randomized,
Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare
the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With
Salmeterol/Futicasone on the Rate of Exacerbations in Subjects With Moderate
to Very Severe COPD (FLAME). [Online] Available at:
http://clinicaltrials.gov/ct2/show/NCT01782326?term=COPD+novartis+52&rank=2.
[Accessed 18 September 2013].

14. FDA Access Data, n.d. Spiriva Medical Review Part 2. [Online]
Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm.
[Accessed 18 September 2013].

15. FDA Access Data, 2003. Advair Medical Review. [Online]
Available at:
www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_S003_ADVAIR_DISKUS.pdf.
[Accessed 18 September 2013].

16. EMA. 2012. Seebri Breezhaler EU Summary of Product Characteristics.
[Online] 17 October 2012. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002430/WC500133769.pdf.
[Accessed 18 September 2013].

17. D'Urzo A et al. Efficacy and safety of once-daily NVA237 in patients with
moderate-to-severe COPD: the GLOW1 trial. Respiratory Research 2011;12:156.

18. Kerwin E et al. Efficacy and safety of NVA237 versus placebo and
tiotropium in patients with COPD: The GLOW2 study. Eur Resp J
2012;40(5):1106-1114.

19. Beeh K et al. Once-daily NVA237 improves exercise endurance from first
dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis
2012;7:503-513.

20. Pavkov et al. Characteristics of a capsule based dry powder inhaler for
the delivery of indacaterol. CMRO 2010; 26; 11:2527–2533.
doi:10.1185/03007995.2010.518916.

21. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive
Pulmonary Disease. Updated 2013.
http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html.
[Accessed 18 September 2013].

22. Fletcher MJ et al. COPD Uncovered: An International survey on the impact
of chronic obstructive pulmonary disease (COPD) on a working age population.
BMC Public Health 2011;11:612.

23. daCosta M et al. The burden of chronic obstructive pulmonary disease among
employed adults. Int J Chron Obstruct Pulmon Dis 2012;7:211-219. Published
online 2012 March doi: 10.2147/COPD.S29280. [Accessed 18 September 2013].

Contact:

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