Vectura upbeat on EMA nod for 'Enerzair Breezhaler'

Inhalation contract manufacturer Vectura Group noted an announcement from Novartis on Friday, that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of ‘Enerzair Breezhaler’.

The London-listed firm said Enerzair Breezhaler, which utilises Vectura's formulation intellectual property, is a maintenance treatment for uncontrolled asthma in adult patients.

Uncontrolled patients are those whose asthma is not adequately controlled with a maintenance combination of a long-acting beta2-agonist, and a high dose of an inhaled corticosteroid, who experienced one or more asthma exacerbations in the previous year.

A final decision from the European Commission regarding the grant of a marketing authorisation is expected to be received about two months after a CHMP opinion.

Upon European regulatory approval, Vectura said it would be eligible to receive a $5m milestone, and thereafter a low-single digit royalty on net sales.

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

“QVM149 combines the bronchodilation of indacaterol acetate - a long-acting beta2-agonist - and the antimuscarinic effects of glycopyrronium bromide - a long-acting muscarinic-antagonist - with mometasone furoate - an inhaled corticosteroid - in a precise once-daily formulation, delivered via the dose-confirming Breezhaler device,” Vectura explained in its statement.

It said that if approved, once-daily Enerzair Breezhaler would be the first combination of the three in a fixed-dose combination for patients suffering from asthma.

“Additional regulatory filings for QVM149 are currently underway in multiple countries, including Switzerland, Japan and Canada,” Vectura confirmed.

At 1420 BST, shares in Vectura were up 1.46% at 86.24p.