Novartis received approval from the European Commission for Enerzair Breezhaler, triggering a $5 million milestone payment to Vectura Group plc, an inhalation CDMO. Enerzair Breezhaler uses Vectura’s formulation IP, and is a first-in-class LABA/LAMA/ICS fixed-dose combination maintenance treatment for patients whose asthma is uncontrolled with LABA/ICS.
On 29th June, Enerzair Breezhaler was approved for use in Japan, triggering a further $1.25 million milestone payment to Vectura. Vectura also receives a 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 with the potential to provide a significant and compelling 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.”
Additional regulatory filings for QVM149 are currently underway in multiple countries, including Switzerland and Canada.