Vectura Group plc (VEC.L) confirmed that Novartis'New Drug Applications or NDAs for QVA149 and NVA237 for the long-term maintenance treatment of chronic obstructive pulmonary disease or COPD have been accepted for review by the US Food and Drug Administration or FDA.The acceptances trigger milestone payments to Vectura of $12.5 million and $7.5 million respectively.
The filings were submitted by Novartis in the fourth-quarter of 2014.
Twice-daily QVA149 (indacaterol/glycopyrronium bromide), 27.5/12.5 mcg, has been submitted for US registration only. Outside of the US, QVA149 has been developed/marketed as Ultibro Breezhaler 110/50 mcg, which is a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Once-daily Ultibro Breezhaler is currently approved for use in over 50 countries, including countries within the EU, Japan, Latin America, Canada, Switzerland and Australia.
Twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg, has been submitted for US registration only. Outside of the US, NVA237 has been developed/marketed as Seebri Breezhaler 50 mcg, which is a once daily medication indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD and is approved for use in over 70 countries, including countries within the EU, Japan, Latin America, Canada, Switzerland and Australia.
Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.
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