Vectura says Bayer completes EU approval procedure for alternative nebulised delivery

Vectura said on Thursday that its partner Bayer has confirmed completion of the EU regulatory procedure that allows an alternative nebulised delivery for its currently-marketed product Ventavis using the London-listed company’s smart nebuliser Fox device.

Ventavis has been developed by Germany’s Bayer for the treatment of pulmonary arterial hypertension with inhaled nebulised delivery. Bayer has branded Vectura’s nebuliser Breelib.

James Ward-Lilley, chief executive of Vectura, said: “We are very pleased with confirmation of this regulatory action which is particularly significant as it represents the first regulatory approval and progression to commercialisation of the Fox smart nebuliser as part of a referenced labelled product.

“Although the financial value for the group from this programme will be limited, given the small patient population, this external platform validation coincides with sustained interest from multiple collaborations who are seeking to leverage the Fox’s unique drug device technology.”

On Wednesday, Vectura announced that Swiss pharmaceutical company Novartis has signed a licensing agreement with Sunovion Pharmaceuticals for the US commercialisation rights to three treatments for chronic obstructive pulmonary disease for which it receives royalty revenues.