Sosei Group Corporation (Sosei), an international biopharmaceutical company,  has  announced that its licensing partner Novartis Pharma K.K. 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.

“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 patient,” said  Shinichi Tamura, CEO, Sosei.

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.

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.

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.