QVA149 Phase III COPD Studies Met Primary Endpoints
TOKYO, April 2, 2012 /PRNewswire/ –
Efficacy, safety and exercise endurance primary endpoints all met
Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), confirms the information
released today by Novartis that the first three QVA149 Phase III studies in the treatment
of chronic obstructive pulmonary disease (COPD) all met their primary endpoints. The
SHINE, BRIGHT and ENLIGHTEN studies, which are part of the IGNITE program demonstrate the
potential of QVA149 in the treatment of COPD.
The results of SHINE, with an enrollment of more than 2,100 patients, met the primary
endpoint by demonstrating the superiority in trough FEV1 (p<0.001) of once-daily QVA149
compared to once-daily indacaterol or once-daily NVA237 in patients with moderate to
severe COPD. In addition, QVA149 showed superiority in trough FEV1 (p<0.001) compared to
placebo and open-label tiotropium (18 mcg).
The results of BRIGHT demonstrated that patients experienced significantly better
exercise endurance versus placebo (p=0.006). ENLIGHTEN demonstrated that QVA149 was well
tolerated with a safety and tolerability profile similar to placebo.
Mr. Shinichi Tamura, CEO of Sosei, commented:
“Achieving the primary endpoints in all three of the Phase III studies,gives us
confidence that QVA149 could be the first LAMA/LABA combination product to provide benefit
to patients with COPD in a multi-billion dollar market that is still growing.”
QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) is an investigational
inhaled, once-daily, fixed dose combination of the long acting beta2-agonist (LABA)
indacaterol, and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide
(NVA237). Data from the IGNITE clinical trial program will be submitted for presentation
to a major medical congress later this year.
IGNITE is one of the largest international patient registration programs in COPD
comprising 10 studies in total. The first seven studies (ENLIGHTEN, BRIGHT, SHINE,
ILLUMINATE, SPARK, BLAZE, ARISE) are expected to complete in 2012 and include more than
5,700 patients across 42 countries and support planned filings in the EU and Japan.
Included in a program is a head-to-head trial vs Seretide(R) (ILLUMINATE), which is
also expected to complete during the second quarter of 2012 and will be incorporated into
the regulatory filings. These studies are designed to investigate efficacy, safety and
tolerability, lung function, exercise endurance, exacerbations, dyspnea and quality of
SHINE is a 26-week, multicenter, randomized, double-blind, parallel-group, placebo and
active controlled pivotal trial of 2,144 patients with moderate to severe COPD to assess
efficacy in terms of trough FEV1.
BRIGHT is a three-week, randomized, blinded, double-dummy, multi-center, placebo
controlled, three-period crossover pivotal trial of 85 patients with moderate or severe
COPD to assess the effect on exercise tolerance of QVA149.
ENLIGHTEN is a 52-week, multicenter, randomized, double-blind, parallel-group, placebo
controlled pivotal trial of 339 patients with moderate or severe COPD to assess the safety
and tolerability of QVA149.
Notes for editors:
NVA237 (glycopyrronium bromide. Seebri(R) Breezhaler(R)) is an investigational
long-acting muscarinic antagonist (LAMA) developed as a once-daily inhaled maintenance
therapy for the treatment of COPD. Phase III data from the GLOW 1, 2 and 3 studies
demonstrated that NVA237 increased patients’ lung function over a 24-hour period compared
to placebo with a fast onset of action at first dose, as well as improving exercise
endurance. It was submitted for regulatory approval in Europe in Q3 2011 and Japan in Q4
Indacaterol (Onbrez(R) Breezhaler(R)) is Novartis’ once daily long acting
beta2-agonist (LABA). Novartis received European regulatory approval for 150 mcg and 300
mcg once-daily doses, under the brand name Onbrez(R) Breezhaler(R) in November 2009. In
July 2011, Novartis announced approval of the 75 mcg once-daily dose in the US under the
brand name Arcapta(TM) Neohaler(TM), and of the 150 mcg once-daily dose in Japan under the
brand name Onbrez(R) Inhalation Capsules.
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
worldwideand is predicted to be the third leading cause of death by 2020. 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.
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
For further information about Sosei, please visit http://www.sosei.com.
1) Seratide(R) is a registered trademark of GSK. 2) 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/uploads/users/files/GOLD_Report_2011_Feb21.pdf Last accessed 23 March 2012. 3) 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 23 March 2012. 4) Fletcher, M, 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.
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SOURCE Sosei Group Corporation