Vectura Group plc Positive flutiform k-haler regulatory progress (7282S)

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RNS Number : 7282S

Vectura Group plc

04 October 2017

Vectura Group plc

flutiform(R) breath-activated k-haler(R) 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(R) k-haler(R) , 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 <BETA>(2) -agonist) is appropriate. Mundipharma's k-haler(R) 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(R)

k-haler is an award-winning(i) 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 Europe(ii) 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 (50/5<MU>g and 125/5<MU>g 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(R)

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 <BETA>2-agonist ("LABA")) is appropriate: for patients not adequately controlled with an ICS and an 'as required' inhaled short-acting <BETA>2-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 50/5<MU>g and 125/5<MU>g strengths for adults and adolescents; 250/10<MU>g 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.

(i) Spark Awards. k-haler. http://www.sparkawards.com/galleries/index.cfm?entry=1DD7D361-0D98-03C9-7058504DE3B54B93 Last accessed September 2017

(ii) Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. npj Primary Care Respiratory Medicine 2014. doi:10.1038/npjpcrm.2014.9

(iii) D.Price et al. "Inhaler errors in the CRITIKAL Study: type, frequency and association with asthma outcomes". Journal of Allergy and Clinical Immunology: In Practice. 2017 DOI: http://dx.doi.org/10.1016/j.jaip.2017.01.004

   (iv)   flutiform SmPC 

(v) Bodzenta-Lukaszyk A, R Buhl, et al. Fluticasone/formoterol combined in a single aerosol inhaler vs budesonide/formoterol for the treatment of asthma: a non-inferiority trial. Eur Respir J 2011a;38:153s

(vi) Bodzenta-Lukaszyk A, Dymek A et al. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulm Med J. 2011;11:28

(vii) Bodzenta-Lukaszyk A, Pulka et al. Efficacy and safety of fluticasone and formoterol. Respir Med J. 2011;105(5):674-82

(viii) Backer V, et al. Real-world study to evaluate the safety and effectiveness of fluticasone propionate/formoterol (FP/FORM) in patients with asthma. Abstract FLT9503, European Respiratory Society (ERS) 2017, Milan

(ix) European Respiratory Society. The European Lung White Book. 2013

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October 04, 2017 11:03 ET (15:03 GMT)