Vectura partner launches Breelib nebuliser in Poland

First launch of product using FOX smart nebuliser.

The application of Ventavis with the Breelib nebuliser was approved by the European Medicines Agency in October 2016. Following the EC Declaration of Conformity, marketability of the medical device was granted by the EU Notified Body in December 2016.

The new Breelib device developed through this collaboration (VR876) with Bayer in the EU and Rest of World territories, excluding the US, has been designed to deliver Ventavis at an optimal particle size and to allow for a breath-actuated nebulisation at a fixed volume and flow rate, utilising the FOX®'s unique flow rate and volume control technology and thereby improving delivery to the lungs. In a clinical trial that compared Breelib with a currently recommended nebuliser, the new device demonstrated a reduction in mean inhalation time of each inhalation from approximately 11 minutes to approximately 3 minutes, providing for a significant reduction in the overall daily treatment duration for patients. These clinical trial results will be published in due course.

James Ward-Lilley, CEO of Vectura, said: "We are pleased to have supported Bayer in this collaboration enhancing drug delivery and ease of device usage for patients with pulmonary arterial hypertension. The launch of the Breelib device marks an important validation of Vectura's mesh based handheld device technology using the FOX smart nebuliser. Breelib's proprietary flow-rate and volume control system is also utilised in Vectura's jet based AKITA nebuliser platforms. Vectura expects to increase the utilisation of the mesh based nebuliser platforms with a number of further partnering collaborations."