21 October 2010 Tokyo, Japan
Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) announce that Novartis have provided an update on NVA237 and QVA149 as part of their Q3, 2010 results presentation.
Key points of note from the presentation:
• NVA237 and QVA149 have expected launch dates of 2012 and 2013 respectively
• An announcement of NVA237 Phase III data in COPD is anticipated in Q2, 2011
NVA237 was licensed to Novartis by Sosei and its co-development partner Vectura in a 2005 deal in which the two companies could receive up to US$375 million in milestones as well as royalties on product sales.
QVA149 is a once-daily, dry powder bronchodilator for inhalation combining a fixed dose of the once-daily beta2–agonist QAB149 (indacaterol) and the longacting muscarinic antagonist NVA237 (glycopyrronium bromide) for the treatment of chronic obstructive pulmonary disease (COPD).
Phase III trials for NVA237 and QVA149 commenced in June 2009 and May 2010 respectively. Novartis received European regulatory approval for indacaterol (Onbrez® Breezhaler® - indacaterol maleate) in November 2009 with the initial launch of the product in Germany in December 2009. US approval is subject to the FDA's review of additional clinical data that Novartis filed at the end of September 2010.