TOKYO, Nov. 7, 2012 /CNW/ - Sosei Group Corporation ("Sosei"; TSE
Mothers Index: 4565) confirms the information released today by
Novartis Pharma K.K. that it has submitted an application for the
registration of QVA149, an investigational fixed dose combination of
two long-acting inhaled bronchodilators (indacaterol maleate and
glycopyrronium bromide), as a once-daily treatment for chronic
obstructive pulmonary disease (COPD) in Japan.
CEO of Sosei, Shinichi Tamura commented:
"This Japanese application, following on from the recent QVA149 filing in
Europe, marks a further important milestone in the approval process for
this innovative once-daily combination therapy which has the potential
to be a safe and effective, dual-activity bronchodilator for the
treatment of COPD patients."
Notes for Editors
QVA149, is an investigational fixed dose combination of two long-acting
inhaled bronchodilators - indacaterol maleate and glycopyrronium
Indacaterol maleate is a long-acting beta2 stimulant that dilates the bronchi by acting on the beta2 receptors in bronchial smooth muscle within 5 minutes of dosing.
Glycopyrronium bromide is a long-acting anticholinergic agent that has
an antagonistic effect on cholinergic muscarinic receptors related to
the contraction of bronchial smooth muscle and thus inhibits
bronchoconstriction. Both agents have different mechanisms of action.
In clinical studies, both agents demonstrated maintenance
bronchodilation over 24 hours administered once daily,.
Novartis has obtained approval for indacaterol maleate in more than 85
countries around the world (as of October 2012) and it was launched
under the brand name Onbrez® Inhalation Capsules 150 g in Japan in September 2011.
Novartis also received approval for glycopyrronium bromide (brand name:
Seebri® Inhalation Capsules 50 g) in Japan in September 2012, and this agent
was approved in the EU during the same month as Seebri® Breezhaler®. The product has since been launched in Germany and the UK and
approvals have also been granted in Canada and Australia.
Glycopyrronium bromide was exclusively licensed to Novartis by Sosei and
its co-development partner Vectura in April 2005, for its development
and marketing worldwide.
The application for QVA149 was filed to the European Medicines Agency in
October 2012 and the US application is planned for 2014.
COPD is a chronic, progressive lung disease that is caused by the
inhalation of harmful substances such as cigarette smoke over a long
period. Its major symptoms include cough, sputum, and dyspnea on
exertion. COPD not only greatly decreases the quality of life for
patients, but is also a life-threatening disease because its symptoms
gradually progress and eventually lead to respiratory failure.
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.
Vogelmeier C, et al. Respir Res. 2010; 11: 135-142.
Verkindre C, et al. Respir Med. 2010; 104: 1482-1489
SOURCE: Sosei Group Corporation
For further information:
Sosei Group Corporation, 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, email@example.com