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Phase III Data Show NVA237 Significantly Improves Lung Function With Good Safety Profile in COPD Patients

April 19, 2011

TOKYO, April 19, 2011 /PRNewswire-FirstCall/ –

– Data From the Novartis Pivotal GLOW1 Study Show Once-Daily NVA237 met
its Primary Endpoint, Demonstrating Superior Bronchodilation (Trough FEV[1])
Relative to Placebo (p<0.001) at 12 Weeks

– NVA237 Significantly Improved Lung Function While Demonstrating a Good
Safety Profile in Patients With Moderate-to-Severe Chronic Obstructive
Pulmonary Disease (COPD)

– Detailed Results to be Presented at a Scientific Congress in H2 2011

Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) announces that
NVA237, a long-acting muscarinic antagonist (LAMA) being investigated as a
once daily treatment for chronic obstructive pulmonary disease (COPD),
achieved its primary end point in a Phase III study. As part of its first
quarter earnings release today, Novartis confirmed results from the first
Phase III clinical trial with once-daily NVA237 (glycopyrronium bromide) show
that it significantly improved lung function while demonstrating a good
safety profile in patients with moderate-to-severe chronic obstructive
pulmonary disease (COPD).

The pivotal double-blind 26-week GLOW1 study met its primary endpoint by
demonstrating superior bronchodilation to placebo at 12 weeks measured by
trough FEV1 (i.e. forced expiratory volume in one second), a standard measure
of lung function (p<0.001).

The incidence of adverse events was similar in the NVA237 treated
patients and in those receiving placebo. Detailed data will be presented at a
scientific congress in H2 2011.

Mr Shinichi Tamura, CEO of Sosei, said:

“We are very encouraged that results from the initial pivotal GLOW1
trial, showing significantly increased lung function with a positive safety
profile, have provided further confirmation of the clinical potential of
NVA237 as a novel once-daily LAMA therapy for COPD patients.”

NVA237 was licensed to Novartis in April 2005 by Sosei and its
co-development partner Vectura. Novartis intends to launch NVA237 in 2012 as
a once-daily monotherapy for COPD. The first launch for QVA149; the
combination of NVA237 with Novartis’ once-daily, long-acting beta2-agonist
(LABA), indacaterol, is planned for 2013. Indacaterol is now approved in more
than 50 countries and available in more than 20, with US approval dependent
on an FDA decision expected in July 2011.

Notes for Editors:

About COPD

COPD is a chronic obstruction of the airways which affects 210 million
people worldwide1 and is projected to be the third leading cause of death by
20202. It is a progressive lung disease with symptoms including chronic
bronchitis and/or emphysema, which slowly progresses and eventually leads to
a largely irreversible loss of lung function. While there is no cure,
bronchodilators such as LAMAs and LABAs make breathing easier by enlarging
the patient’s airways, and are recognised in international guidelines as an
integral part of the treatment for COPD.

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. WHO. Factsheet No 315: Chronic obstructive pulmonary disease (COPD),
Available at: htttp://www.who.int/mediacentre/factsheets/fs315/en/index.html.

2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive
Pulmonary Disease. Updated 2009. Available at:
http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=2003.

SOURCE Sosei Group Corporation


Source: newswire



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