Tokyo, Japan – 18 January 2008: Sosei Group Corporation (“Sosei”, TSE Mothers Index: 4565), a biopharmaceutical company, today announces that Novartis, in its 2007 Annual Report, has reported that the expected NDA filing dates for both NVA237 and QVA149 have been amended.
Novartis announced in September 2007 that it expected to initiate Phase III trials in 2008, with an expectation to file NDAs (New Drug Applications) in 2010. Today, Novartis updated their expected filing dates for both products, to 2011. The start of the Phase III programme will trigger a substantial milestone payment to Sosei.
NVA237 is a once-daily, rapid onset, long-acting muscarinic antagonist (LAMA), which Novartis intends to launch as a once-daily treatment for COPD. QVA149 comprises the combination of NVA237 with Novartis’s once-daily, long-acting beta agonist (LABA), indacaterol (or QAB149), which is currently in Phase III development