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QVM149 receives regulatory approval in Europe and Japan

Published:07/07/2020

Vectura today confirms the announcement made by Novartis that the European Commission has approved QVM149;indacaterol acetate, glycopyrronium bromide and mometasone furoate. QVM149, which utilises Vectura’s formulation IP, is a first-in-class LABA/LAMA/ICS fixed-dose combination maintenance treatment for patients whose asthma is uncontrolled with LABA/ICS.

European regulatory approval has triggered a $5.0m milestone to Vectura from Novartis. On 29th June, Novartis also announced that Enerzair® Breezhaler® was approved for use in Japan. This approval triggered a further $1.25m milestone payment to Vectura and the Group will receive a low-single digit royalty on net sales of the product in both territories.

Will Downie, Chief Executive Officer of Vectura, said:

“This is an important regulatory approval for asthma patients in Europe and Japan. Novartis has developed a product which provides an additional treatment option for patients with uncontrolled asthma. Vectura’s revenue stream will benefit from $6.25 million in milestone payments in 2020, plus a low-single digit royalty on future net sales of the product.”

About QVM149

Vectura and Sosei Heptares exclusively licensed glycopyrronium bromide and certain intellectual property relating to its use and formulation to Novartis in April 2005. Novartis is responsible for the development and commercialisation of QVM149.

QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.

For further information on European approval of Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate), please visit Novartis’ website: https://www.novartis.com/news

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