Positive flutiform k-haler regulatory progress

Vectura Group plc

flutiform® breath-activated k-haler® makes positive European regulatory progress

Chippenham, UK - 4 October 2017: Vectura Group plc (LSE: VEC) ("Vectura", "the Group"), an industry-leading device and formulation business for inhaled airways products, announces that its partner Mundipharma and its network of independent associated companies has confirmed the successful outcome of the European Decentralised Procedure ("DCP") for flutiform® k-haler®, a novel asthma treatment for adults and adolescents (aged 12 years and older) where the use of a combination product (inhaled corticosteroid and long-acting β2-agonist) is appropriate. Mundipharma's k-haler® is an aerosol device with a breath-activated mechanism, activated with a low inspiratory force, which is designed to make it easier for patients to use correctly. The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") acted as the Reference Member State for the DCP, which covers 18 countries across Europe.

James Ward-Lilley, Chief Executive Officer of Vectura:

"Uncontrolled asthma is commonly associated with incorrect inhaler technique, coupled with poor adherence to therapy. The k-haler's patented breath-activated mechanism removes the need for co-ordination of actuation with inhalation, with only a gentle inspiration required to trigger the dose. This positive DCP outcome is an important step in the regulatory process and Mundipharma can now begin to apply for national approvals and reimbursement in the European countries covered by this procedure. The launch of the enhanced flutiform k-haler device, in due course, will represent a helpful life cycle management for an already successful product and supports our confidence in the further evolution of flutiform revenues."

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About Vectura

Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading device and formulation business for inhaled airways products offering a uniquely integrated inhaled drug delivery platform. With our extensive range of device and formulation technologies, integrated capabilities and collaborations, we are a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases. 

Vectura has eight inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams. The Group has a diverse portfolio of drugs in clinical development, including a number of novel and generic programmes which are partnered with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall, Janssen, Dynavax and Tianjin KingYork along with two wholly owned nebulised development programmes.

About k-haler®

k-haler is an award-winningi aerosol device with a simple breath-triggered mechanism, activated with a low inspiratory force, which is designed to make it easier for patients to use correctly, including those who may find other devices challenging to use. Sub-optimal asthma control remains a major problem for patients in Europeii and errors in inhaler technique are contributing to poor outcomes, leading to unnecessary healthcare costs.iii

flutiform k-haler contains the same combination of fluticasone propionate and formoterol fumarate (50/5μg and 125/5μg strengths) as Mundipharma's existing asthma maintenance combination treatment, flutiform pMDI (pressurised metered dose inhaler).iv The efficacy and tolerability of flutiform pMDI, first launched five years, is supported by extensive clinical and real-world evidence.iv,v,vi,vii,viii

In Europe, approximately 30 million people under the age of 45 have asthma.ix Poor asthma control is associated with increased risk of exacerbations, impaired quality of life, increased healthcare utilisation and reduced productivity.ii New research indicates that errors in inhaler technique are frequent (made by over 30% of patients in some cases) and can reduce control of asthma.iii Choosing the right inhaler type for each patient can help to reduce the number of critical inhaler errors and ultimately improve patient health.iii

About flutiform®

In Europe, flutiformis licensed for the regular treatment of asthma in patients aged 12 years and over when use of a combination product (an inhaled corticosteroid ("ICS") and a long-acting β2-agonist ("LABA")) is appropriate: for patients not adequately controlled with an ICS and an 'as required' inhaled short-acting β2-agonist or for patients already adequately controlled on both an ICS and a LABA. It is available in 20 countries across Europe including the UK, Germany, France, Spain, Netherlands and Italy. flutiform is available in 50/5μg and 125/5μg strengths for adults and adolescents; 250/10μg strength for adults only.

About asthma

Asthma is a chronic inflammatory disorder of the airways which leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Patients with poorly managed asthma are at an increased risk of exacerbations, hospitalisation and death. Poorly managed asthma can also have a huge impact on a person's quality of life and day-to-day activities. ix

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.