Breelib™ meets iloprost

Breelib is a small handheld, battery-powered, breath activated, vibrating mesh technology inhalation system utilising the FOX®’s unique flow rate and volume control technology. It is a smart nebuliser device designed to provide patients with both an easier to use device and improved delivery of Ventavis® (iloprost), a well-established inhaled treatment for patients with pulmonary arterial hypertension.

Drug product is available at 10 microgram/ml (1 ml ampoule) and 20 microgram/ml nebuliser solution through the technology.

Patients can initiate on Ventavis iloprost with this device or switch from an alternative device.

In October 2012, Vectura established a collaboration with Bayer to develop Breelib, a smart hand-held nebuliser device designed to provide patients with both an easier to use device and improved delivery of Bayer’s Ventavis® (iloprost), a well-established inhaled treatment for patients with PAH.

Together with Bayer, Vectura used its in-house respiratory expertise to customise its proprietary FOX® platform to design a patient-focused drug specific nebuliser system to match the high-performance profile of the existing device.

The Bluetooth® enabled device incorporates a patient feedback mechanism, which helps to guides a patients breathing during the inhalation process. To improve inhalation technique, the BreelibTM mouthpiece will glow green if the patient is breathing with the right speed and force and red for sub-optimal breathing. Vectura also supported the development of the BreeConnect app solutions, which helps patients to monitor the number of inhalations they have taken a day, reminds them when to inhale and shares the data with their doctor, providing an enhanced patient experience. In 2014, the FOX® device won the Red Dot Award for product design.

Now approved in Poland, Germany, Austria, Portugal and the UK with further roll-out underway. The adapted FOX® handheld smart nebuliser, which utilises Vectura’s unique FAVORITE inhalation technology, is able to significantly reduce each treatment time from 11 minutes to three minutes, whilst maintaining efficacy. This reduction in treatment time, along with an improved cleaning regime, saves a typical patient over one hour per day.

Leveraging our strong clinical and regulatory capabilities throughout the development of Breelib, Vectura supported the planning of the required clinical studies with drug delivery, device and PAH experts providing support for the dosing strategy, patient-specific device parameters, and undertaking device validation and device vigilance.

Vectura handled all aspects of industrialisation and supply of the Breelib inhalation device, and were responsible for the GMP manufacturing of the device from clinical trials through to commercial launch. Vectura supported Bayer by enabling a seamless transition and transfer of the Breelib design to commercial manufacturing sites to support the scale up and industrialisation of the device.

Working closely with Bayer, Vectura was part of the market launch team, performing device workshops and training for the Bayer commercial team and healthcare professionals.

"Faster delivery and an improved cleaning regime saves the typical patient over one hour a day."