Novartis has filed a marketing application with the EMA for its QVA149 indacaterol maleate/glycopyrronium bromide DPI for the treatment of COPD. The filing triggered milestone payments of $5 million each to the drug’s developers, Vectura and Sosei.
Vectura Chief Executive Chris Blackwell, “The IGNITE program is among the largest COPD clinical trial programs performed, the results from which provide strong support as to the effectiveness and safety of QVA149 and its potential to treat patients suffering from this progressive disease, a multi-billion dollar market that is expected to see continued growth. Today’s news follows the recent approval of Seebri Breezhaler in Europe and Canada and Seebri Inhalation Capsules in Japan, further highlighting Vectura’s expertise in the respiratory therapeutic area.”
Sosei CEO Shinichi Tamura added, “We are delighted with the EU filing for QVA149.”
The companies have stated that Novartis plans to file an NDA for QVA149 by the end of 2014.
Read the Vectura press release.
Read the Sosei press release.
