TOKYO, November 7, 2012 /PRNewswire/ --

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

About QVA149

QVA149, is an investigational fixed dose combination of two long-acting inhaled bronchodilators - indacaterol maleate and glycopyrronium bromide.

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^[1],[2].

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.

About COPD

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.

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.

Reference:

1. Vogelmeier C, et al. Respir Res. 2010; 11: 135-142.
2. Verkindre C, et al. Respir Med. 2010; 104: 1482-1489

SOURCE Sosei Group Corporation