Novartis has submitted its new chronic obstructive pulmonary disease drug NVA237 for approval in Japan.
NVA237 (glycopyrronium bromide) is a long-acting muscarinic antagonist (LAMA) which was filed for approval in the European Union in September as a once-daily treatment for COPD under the brand name Seebri Breezhaler. Novartis licensed the drug from Japan's Sosei and Vectura of the UK in April 2005.
The latter company's chief executive, Chris Blackwell, noted that "the Japanese market is a large and growing market" with an estimated five million people suffering from COPD". He added that the filing in Japan "therefore represents an important milestone for us ahead of an anticipated approval and launch of NVA237 in Europe over the course of the next 12 months." Vectura has already banked $35 million from Novartis, and could receive up to an additional $152.5 million on regulatory and commercialisation targets.
NVA237 has been developed as monotherapy and also a fixed-dose combination with Novartis' own Onbrez Breezhaler (indacaterol), a once-daily therapy in the long-acting beta 2-agonist (LABA) class. Observers are particularly excited about the latter which is known as QVA149, as it could be the first once-daily LAMA/LABA combo to come to market for COPD.
Last week, Novartis signed up Eisai as a co-promotion partner for Onbrez, which was approved in Japan in July, and if approved, NVA237 and QVA149.