NVA237 has been filed for marketing authorisation by Novartis with the
European Medicines Agency (EMA) under the brand-name Seebri®
Breezhaler®, triggering a $5m milestone payment to Sosei
TOKYO, Sept. 27, 2011 /CNW/ - Studies show investigational once-daily
NVA237 provides superior 24-hour bronchodilation and increases exercise
endurance relative to placebo
Additional data show NVA237 significantly prolonged time to first
moderate/ severe COPD exacerbation and reduced associated
hospitalizations compared to placebo
Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), today
announces that NVA237 (glycopyrronium bromide), a long-acting
muscarinic antagonist (LAMA) being investigated as a once-daily
treatment for chronic obstructive pulmonary disease (COPD), has been
filed by Novartis for marketing authorisation with the European
Medicines Agency (EMA), under the brand-name Seebri® Breezhaler®, triggering a $5m milestone payment to Sosei.
In addition, Novartis has presented new NVA237 Phase III data at the
European Respiratory Society (ERS) congress. The GLOW1 and GLOW3
studies in chronic obstructive pulmonary disease (COPD) patients show
that NVA237 (glycopyrronium bromide) significantly increased patients'
lung function compared to placebo with a fast onset of action at first
dose, as well as improving exercise endurance. NVA237 is a new drug in
the long-acting anti-muscarinic (LAMA) class.
The GLOW1 study met its primary endpoint by showing that NVA237 50 mcg
once-daily produced a significant improvement in lung function of 108
mL in trough FEV1 (forced expiratory volume of breath in one second) after 12 weeks in
patients with moderate-to-severe COPD compared to placebo (p<0.001).
Moreover, NVA237 had a rapid onset of action, with a 93 mL improvement
in FEV1 compared to placebo at five minutes post-dose following the first dose
on the first day of treatment (p<0.001).
NVA237 also significantly prolonged the time to first moderate/severe
COPD exacerbation compared to placebo, and reduced the percentage of
associated hospitalizations. Significant improvement in breathlessness
was seen at 26 weeks compared to placebo, accompanied by a significant
improvement in health-related quality of life and reduction in the use
of rescue medication.
The GLOW3 study investigated the effects of NVA237 50 mcg once-daily on
exercise endurance in moderate-to-severe COPD patients. The study met
its primary endpoint by showing a significant 21% improvement in
exercise endurance versus placebo at the end of the study (i.e. day
21), with a significant 10% increase from day one (both p<0.001).
Both studies showed that NVA237 was well-tolerated, with a similar
incidence of adverse events for patients treated with NVA237 and
Mr Shinichi Tamura, CEO of Sosei, said:"The filing of this product originating from Sosei and Vectura is an important milestone for us and is further endorsement of our
capabilities. The NVA237 Phase III data at ERS illustrate the potential benefits of
NVA237 for patients with COPD; a multi-billion dollar market that is
still growing. Novartis has a rich portfolio of once-daily inhaled therapies to help
COPD patients and has stated that it expects to file QVA149, the fixed-dose combination of NVA237 and their
once-daily LABA, indacaterol, in 2012. The combination of two bronchodilators with
complementary modes of action is designed to give COPD patients access
to two leading classes of therapy in a single inhaler for the first
Notes for Editors:
About the NVA237 Licence Agreement with Novartis
NVA237 was licensed to Novartis in April 2005 by Sosei and its
co-development partner, Vectura. Novartis has stated that it intends
to launch NVA237 in 2012 as a once-daily monotherapy for COPD and as a
fixed-dose combination with indacaterol, its once-daily, long-acting
beta-agonist (LABA), known as QVA149, in 2013. Sosei believes that it
could be the first once-daily LAMA/LABA combination to come to market
for COPD. The dual activity of a muscarinic antagonist and a
beta-adrenergic agonist promises to be a potent bronchodilator and,
with convenient once-daily dosing as a fixed-dose combination, has the
potential to improve compliance and address a large and unmet need for
Novartis received European regulatory approval for Onbrez® Breezhaler® in November 2009. In July 2011, Novartis announced approval of the 75
mcg once-daily dose in the US under the brand name Arcapta™ Neohaler™,
and of the 150 mcg once-daily dose in Japan under the brand name Onbrez® Inhalation Capsules.
To date, Sosei has received $30m from Novartis and, under the terms of
the licence, could receive up to an additional $157.5m for achievement
of regulatory and commercialisation targets for both the monotherapy
and the combination product. In addition, royalties on product sales
will be received in the event of successful product launches.
COPD is a progressive, life-threatening disease associated with tobacco
smoking, air pollution or occupational exposure, which causes
obstruction of airflow in the lungs resulting in debilitating bouts of
breathlessness. COPD affects 210 million people worldwide and is
projected to be the third leading cause of death by 2020. Although
often considered a disease of the elderly, research has shown that a
majority of COPD patients are under the age of 65 when they are likely
to be 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 markets.
For further information about Sosei, please visit http://www.sosei.com.
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
For further information:
Tokyo Office, Milica STOJKOVIC, Investor Relations, +81-(0)3-5210-3399, firstname.lastname@example.org. London Office, Kathryn LYDON, PA to CEO & Corporate Communication, +44-(0)20-7691-0983, KLydon@sosei.com