Vectura : VR876 – confirmation of alternative nebulised delivery device for Bayer’s Ventavis (iloprost) using adapted Vectura FOX® device

December 22, 2016 at 7:00 AM

Chippenham, UK - 22 December 2016: Vectura Group plc (LSE: VEC) ('Vectura', 'the Group'), an industry-leading inhaled airways disease focused business, announces that Bayer AG ('Bayer'), our partner on VR876, has confirmed completion of the EU regulatory procedure that allows an alternative nebulised delivery (method of administration) for its currently marketed product Ventavis (iloprost) using Vectura's handheld smart nebuliser FOX® device which Bayer has branded Breelib®.

VR876 - Europe/RoW
Ventavis has been developed by Bayer for the treatment of pulmonary arterial hypertension with inhaled nebuliser delivery. VR876 has been developed by Bayer, using an adapted Vectura FOX® smart nebuliser and branded by Bayer as the Breelib® device.

Breelib®
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. The drug product now available through the Breelib device is Ventavis 10 microgram/ml (1 ml ampoule) and Ventavis 20 microgram/ml nebuliser solution. Patients can initiate on Ventavis with this device or switch from an alternative device.

For further information please go to this link:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000474/human_med_001133.jsp&mid=WC0b01ac058001d124

James Ward-Lilley, CEO of Vectura, commented:
'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. We look forward to announcing a number of these new partnerships in 2017.'

- Ends -

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Vectura Group plc
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Andrew Derodra - Chief Financial Officer
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About Vectura
Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading inhaled airways disease focused business with proprietary formulation and devices across DPI, pMDI and smart nebulisation platforms. With our extensive range of technologies, capabilities and collaborations, we believe we can become a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases. In June 2016 Vectura completed a merger with Skyepharma PLC.

Vectura has seven inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a portfolio of drugs in clinical development, a number of which have licence agreements with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Chiesi, Almirall, Janssen, and Tianjin KingYork.
For further information, please visit Vectura's website at www.vectura.com.

Pulmonary Arterial Hypertension (PAH)
PAH is a chronic, life-threatening disorder characterised by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The symptoms of PAH are non-specific and can range from mild breathlessness and fatigue during normal daily activity to symptoms of right heart failure and severe restrictions on exercise capacity and ultimately reduced life expectancy. PAH is one group within the classification of pulmonary hypertension (PH). This group includes idiopathic PAH, heritable PAH and PAH caused by factors which include connective tissue disease, HIV infection and congenital heart disease.

The last decade has seen significant advances in the understanding of the pathophysiology of PAH, which has been paralleled with developments of treatment guidelines and new therapies. Drugs targeting the three pathways that have been established in the pathogenesis of PAH are endothelin receptor antagonists (ERAs), prostacyclin receptor agonists, and phosphodiesterase-5 inhibitors. PAH treatments have transformed the prognosis for PAH patients from symptomatic improvements in exercise tolerance 10 years ago to delayed disease progression today. Improved disease awareness and evidence-based guidelines developed from randomised controlled clinical trial data have highlighted the need for early intervention, goal-oriented treatment and combination therapy.

Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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