TIDMVEC
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."
- Ends -
Enquiries
Vectura Group plc +44 (0)1249 667 700
Andrew Derodra - Chief Financial Officer
Fleur Wood - Director Communications
Elizabeth Knowles - Director Investor Relations and Analysis
Consilium Strategic Communications +44 (0)20 3709 5700
Mary-Jane Elliott / Sue Stuart / Jessica Hodgson vectura@consilium-comms.com
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
This information is provided by RNS
The company news service from the London Stock Exchange
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