Sosei Group Corporation QVA149 Phase III Study Meets Primary Endpoint in Reducing Exacerbations in COPD Patients and Filings in EU and Japan by End of Year
TOKYO, August 30, 2012/PRNewswire-FirstCall/ --
- SPARK demonstrated QVA149 statistically
significantly reduced rate of
moderate-to-severe exacerbations
compared to glycopyrronium 50 mcg[1]
- Study showed QVA149 statistically
significantly reduced overall exacerbation
rates compared to glycopyrronium 50
mcg and open-label tiotropium 18 mcg[1]
- SPARK is the final study of the IGNITE Phase
III clinical trial program
intended for initial regulatory
filings
Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) confirms
the information released today by Novartis that results from the
fifth QVA149 (indacaterol maleate / glycopyrronium bromide) Phase
III study, SPARK, met its primary endpoint of a reduced rate of
moderate-to-severe COPD exacerbations compared to glycopyrronium
bromide (Seebri(R) Breezhaler(R))[1]. SPARK is the final study
intended for initial regulatory filings of QVA149 in Europe and
Japan, which are expected in Q4 2012. US filing of QVA149 is
expected at the end of 2014. To date, the first five studies of the
IGNITE QVA149 Phase III clinical trials program have all met their
primary endpoints of efficacy, safety, exercise endurance, and
reduction of exacerbations[1-5].
SPARK met its primary endpoint by demonstrating that patients
treated with once-daily (QD) investigational QVA149 for 64 weeks
demonstrated a clinically meaningful and statistically significant
lower rate of moderate-to-severe COPD exacerbations compared to
patients treated with QD glycopyrronium 50 mcg (p=0.038)[1]. The
study also showed that the rate of moderate-to-severe exacerbations
was numerically lower (p=0.096) in patients on QVA149 compared to
open-label (OL) tiotropium 18 mcg[1].
A further analysis of the data demonstrated that QVA149 was
statistically significantly more effective in reducing the overall
rate of all exacerbations (mild, moderate and severe) compared to
glycopyrronium 50 mcg (p=0.001) and OL tiotropium 18 mcg
(p=0.002)[1]. The adverse event (AE) profile of QVA149 was similar
to both glycopyrronium 50 mcg and OL tiotropium 18 mcg[1].
The management of COPD exacerbations is important to both patients
and physicians, as exacerbations can impose a significant burden of
morbidity, mortality, reduced quality of life and healthcare
costs[6,7]. Frequent exacerbations are linked to an accelerated
decline in lung function[8,9] and patients are also known to have a
poorer quality of life[10]. Admissions to hospital due to
exacerbations are increasing[11] and patients with more severe
underlying disease account for around 70% of the direct medical
costs of COPD[12].
SPARK was a 64-week, multi-center, randomized, double-blind,
parallel-group, active controlled study designed to evaluate the
effect of QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50
mcg) QD versus glycopyrronium 50 mcg and QD OL tiotropium 18 mcg on
moderate-to-severe COPD exacerbations in 2,224 patients with severe
to very severe COPD[1].
QVA149 is an investigational inhaled, once-daily, fixed-dose
combination of the long-acting beta2-adrenergicagonist (LABA)
indacaterol maleate, and the investigational long-acting muscarinic
antagonist (LAMA) glycopyrronium bromide, being 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 10 studies in total with more than
7,000 patients across 42 countries[1-5,13-20]. The first five
studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK) have already
completed in 2012 with three additional studies (BLAZE, ARISE,
BEACON) expected to complete by the end of the year. The studies
are designed to investigate efficacy, safety and tolerability,
exercise endurance, exacerbations, breathlessness and quality of
life[1-5,13-17].
CEO of Sosei, Shinichi Tamura commented:
"The SPARK study demonstrated a meaningful reduction in
exacerbations in COPD patients; something that is of major benefit
for patients and doctors and eases the burden of healthcare costs.
We look forward to more detailed data from both glycopyrronium
bromide (NVA237) and QVA149 at the upcoming European Respiratory
Society meeting in Vienna in early September with the first filings
for QVA149 expected in Europe and Japan by the end of this
year."
Notes for editors
About NVA237/QVA149
NVA237 (glycopyrronium bromide - Seebri(R) Breezhaler(R)) was
licensed to Novartis in April 2005 by Sosei and its co-development
partner, Vectura. It is an investigational LAMA developed as a
once-daily inhaled maintenance therapy for the treatment of COPD.
Phase III data from the GLOW1, 2 and 3 studies demonstrated that
glycopyrronium bromide increased patients' lung function over a
24-hour period compared to placebo with a fast onset of action at
first dose, and improved exercise endurance versus
placebo[21-23].
QVA149 is an investigational inhaled, once-daily, fixed-dose
combination of NVA237 and the LABA, indacaterol maleate, for which
Novartis received European regulatory approval as Onbrez(R)
Breezhaler(R) in November 2009. It was first launched in the EU in
150 mcg and 300 mcg once-daily doses. Most recently, Novartis
launched the 75 mcg once-daily dose in the US under the brand name
Arcapta[TM] Neohaler[TM]. It is also available as a 150 mcg
once-daily dose in Japan under the brand name Onbrez(R) Inhalation
Capsules.
All of the Novartis COPD portfolio products are being developed for
delivery via the Breezhaler(R) device, a single-dose dry powder
inhaler (SDDPI), which has low air flow resistance, making it
particularly suitable for patients with airflow limitation, such as
COPD patients. The Breezhaler(R) device allows patients to hear,
feel and see that they have taken the drug correctly[18].
About COPD
COPD is a progressive disease associated mainly with tobacco
smoking, air pollution or occupational exposure, which can cause
obstruction of airflow in the lungs resulting in debilitating bouts
of breathlessness. It affects an estimated 210 million people
worldwide[24] and is predicted to be the third leading cause of
death by 2020[25]. Although COPD is often thought of as a disease
of the elderly, 50% of patients are estimated to be within the ages
of 50 and 65, which means that half of the COPD population are
likely to be impacted at the peak of their earning power and family
responsibilities[ 26].
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 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.
References
1) ClinicalTrials.gov. Effect of QVA149 Versus
NVA237 and Tiotropium on
Chronic Obstructive Pulmonary
Disorder (COPD) Exacerbations (SPARK). NCT01120691.
http://www.clinicaltrials.gov/ct2/show/NCT01120691?term=NCT01120691.&rank=1.
Last
accessed 21 August 2012.
2) ClinicalTrials.gov. QVA149 versus
Fluticasone/Salmeterol in Patients With
Chronic Obstructive Pulmonary
Disease (COPD) (ILLUMINATE). NCT01315249
http://www.clinicaltrials.gov/ct2/show/NCT01315249?term=NCT01315249&rank=1.
Last
accessed 21 August 2012.
3) ClinicalTrials.gov. A Study to Assess the
Efficacy, Safety and Tolerability
of Once-daily QVA149 in Patients
With Moderate to Severe Chronic Obstructive Pulmonary
Disease (COPD) (SHINE).
NCT01202188.
http://www.clinicaltrials.gov/ct2/show/NCT01202188?term=NCT01202188&rank=1.
Last
accessed 21 August 2012.
4) ClinicalTrials.gov. Effect of QVA149 on
Exercise Tolerance in Patients With
Chronic Obstructive Pulmonary
Disease (COPD) (BRIGHT). NCT01294787.
http://www.clinicaltrials.gov/ct2/show/NCT01294787?term=NCT01294787.&rank=1.
Last
accessed 21 August 2012.
5) ClinicalTrials.gov. A Study to Assess the
Long-term Safety of QVA149
(ENLIGHTEN). NCT01120717.
http://www.clinicaltrials.gov/ct2/show/NCT01120717?term=NCT01120717&rank=1.
Last
accessed 21 August 2012.
6) Simoens S et al. Clinical and economic
analysis of antimicrobial therapy of
chronic obstructive pulmonary
disease exacerbations. Int J Clin Pract.
2007;61:200-206.
7) Hurst J et al. Chronic obstructive pulmonary
disease: the clinical management
of an acute exacerbation. Postgrad
Med J. 2004;80:497-505.
8) Kanner R, et al. Lower respiratory illness
promote FEV1 decline in current
smokers but not ex-smokers with mild
chronic obstructive pulmonary disease. Results
from the Lung Health Study. Am J
Respir Crit Care Med 2001;164:358-64.
9) Donaldson G et al. Relationship between
exacerbation frequency and lung
function decline in chronic
obstructive pulmonary disease. Thorax. 2002;57:847-52.
10) Seemungal TAR et al. Effect of
exacerbation on quality of life in patients
with chronic obstructive pulmonary
disease. Am J Respir Crit Care Med.
1998;157:1418-22.
11) Lung and Asthma Information
Agency. Trends in hospital admissions for lung
disease. Fact sheet 2001/4. London:
St George's Hospital Medical School.
12) Sullivan S et al. The economic
burden of COPD. Chest. 200;117(suppl):5S-9S.
13) ClinicalTrials.gov. The Effect
of QVA149 on Dyspnea in Patients With Chronic
Obstructive Pulmonary Disease (COPD)
(BLAZE). NCT01490125.
http://www.clinicaltrials.gov/ct2/show/NCT01490125?term=NCT01490125.&rank=1.
Last
accessed 21 August 2012.
14) ClinicalTrials.gov. Long Term
Safety and Tolerability of QVA149 Versus
Tiotropium in Japanese Patients With
Chronic Obstructive Pulmonary Disease (COPD)
(ARISE). NCT01285492.
http://www.clinicaltrials.gov/ct2/show/NCT01285492?term=NCT01285492.&rank=1.
Last
accessed 21 August 2012.
15) ClinicalTrials.gov. 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).
http://www.clinicaltrials.gov/ct2/show/NCT01529632?term=BEACON&rank=6.
Last accessed 22 August 2012.
16) ClinicalTrials.gov. 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 (GLISTEN).
http://www.clinicaltrials.gov/ct2/show/NCT01610037?term=GLISTEN&rank=1.
Last
accessed 22 August 2012.
17) ClinicalTrials.gov. The Effect
of QVA149 on Health Related Quality of Life
in Patients With Chronic Obstructive
Pulmonary Disease (COPD) (QUANTIFY).
http://clinicaltrials.gov/ct2/show/NCT01574651?term=QUANTIFY&rank=1.
Last accessed
22 August 2012.
18) Onbrez(R) Breezhaler(R)
(indacaterol) EU Summary of Product Characteristics
May 31, 2011
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001114/human_med_001219.jsp&mid=WC0b01ac058001d124
. Last accessed 21 August
2012.
19) FDA Access Data. Spiriva(R)
HandiHaler(R) Medical Review Part 2, pages
37-38.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm.
Last accessed 21 August 2012.
20) FDA Access Data. Advair Medical
Review Nov. 17, 2003, Page 133.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_S003_ADVAIR_DISKUS.pdf
. Last accessed 21 August
2012.
21) 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 (7 December
2011).
22) Kerwin E, et al. Efficacy and
safety of NVA237 versus placebo and tiotropium
in patients with moderate-to-severe
COPD over 52 weeks: The GLOW2 study. Eur Resp J.
2012. Published on July 26, 2012
(doi:10.1183/09031936.00040712). Last accessed 21
August 2012.
23) Beeh K, Drollmann A, Di Scala L,
Smith R. 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.
24) 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%20Book%202007.pdf
Last accessed 21
August 2012.
25) Global Initiative for Chronic
Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis,
Management, and Prevention of Chronic Obstructive
Pulmonary Disease. Updated
2011.
http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html.
Last accessed 21 August 2012.
26) 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.
Source: Sosei Group Corporation
Sosei Group Corporation: Tokyo Office, Milica STOJKOVIC,
Investor Relations, +81(0)3-5210-3399, mstojkovic@sosei.com; London
Office, Kathryn LYDON, PA to CEO & Corporate Communication,
+44(0)20-7691-0983, klydon@sosei.com
Posted: August 2012
