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10.09.2017 – 01:04

Mundipharma International

New data Presented at ERS 2017 on flutiform® k-haler®(fluticasone propionate and formoterol), Mundipharma's Novel Breath-triggered Aerosol Inhaler

England (ots/PRNewswire)

- flutiform k-haler achieved high levels of lung deposition of over 
  44% of delivered dose
- Plume force of flutiform k-haler was compared with fluticasone 
  propionate/salmeterol xinafoate delivered via the Seretide® 
  Evohaler® pMDI and Sirdupla® pMDI devices
- Pharmacokinetic studies show efficacy and safety profile of new 
  flutiform k-haler device would be comparable to flutiform pMDI 

Mundipharma today announced new data from four studies demonstrating efficient drug delivery characteristics with flutiform® k-haler®, a novel, breath-triggered inhaler, currently in development.

The efficacy of inhaled asthma treatments is dependent on adequate deposition of the drug in the lungs. Poor or improper inhaler technique in asthma patients can lead to critical inhaler errors and is associated with reduced disease control,[1],[2] worse asthma outcomes[3] and an increase in hospital visits, compared to patients with good inhaler technique.[1]

The flutiform k-haler takes its name from a unique kinked valve which removes the need for co-ordination, with only gentle inhalation required to trigger the aerosol.

Details of the four flutiform k-haler presentations

The first study examined the pulmonary deposition of the flutiform k-haler device (125/5 microgram) using gamma scintigraphy and showed that in patients with asthma, high levels of lung deposition of over 44% of the delivered dose were achieved.[4]

A second in vitro study compared the plume force of flutiform k-haler 125/5µg with fluticasone propionate/salmeterol xinafoate 125/25µg (FP/SAL) from the Seretide® Evohaler® pMDI; and 125/25µg FP/SAL from the Sirdupla® pMDI over distances of 25-95mm. 60-95mm represents the typical distance between the inhaler and back of the throat. [5] Plume characteristics of aerosol devices may affect drug delivery to the lungs and impaction at the back of the throat.[5]

The final two single dose, cross-over pharmacokinetic studies assessed how pulmonary bioavailability and systemic exposure of fluticasone propionate and formoterol 125/5µg of flutiform k-haler compared to Mundipharma's existing flutiform pMDI device when administered in healthy adults with or without a spacer. These data suggest that the efficacy (based on pulmonary bioavailability) and safety (based on total systemic exposure) profile of the new device would be comparable to the registered flutiform pMDI device. [6],[7]

Jonathan Marshall, Head of Medical Insights, Mundipharma International Limited commented: "The studies presented at this year's ERS conference demonstrate how effective the k-haler is at delivering fluticasonepropionate/formoterol to the lungs,achieving high levels of lung deposition in patients with asthma. If approved, flutiform k-haler would offer a new device choice for certain patients with asthma."

Notes to editors:


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About the Mundipharma network
The Mundipharma global network of privately-owned independent
associated companies was founded in 1956 by doctors, and now operates
in over 120 countries worldwide. We are focused on developing business
partnerships to identify and accelerate meaningful technology across
an increasingly diverse portfolio of therapy areas including
respiratory, oncology, pain, and biosimilars. Consistent with our
entrepreneurial heritage, we like to think we see what others don't by
challenging conventional wisdom and asking different and challenging
questions. By working in partnership with all our stakeholders, the
Mundipharma network develops medicines that create value for patients,
payers and wider healthcare systems.
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About flutiform pMDI
In Europe, flutiform pMDI is licensed for the regular treatment of
asthma when use of a combination product (an inhaled corticosteroid
[ICS] and a long-acting ?2-agonist [LABA]) is appropriate: for
patients not adequately controlled with an ICS and an 'as required'
inhaled short-acting ?2-agonist or for patients already adequately
controlled on both an ICS and a LABA. It is available in countries
across Europe including the UK, Germany, France, Spain, Netherlands
and Italy. flutiform pMDI is available in 50/5?g and 125/5?g strengths
for adults and adolescents; 250/10?g strength for adults only.[8]
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
About Gamma Scintigraphy
Gamma scintigraphy is an imaging technique using radioisotopes
attached to drugs that travel to a specific organ or tissue and the
emitted gamma radiation is captured by external detectors. This
enables the direct visualisation and quantification of events
occurring in vivo, in real time.
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 its extensive range of device and formulation
technologies, integrated capabilities and collaborations, Vectura is a
leader in the development of inhalation products, increasing its
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.
1. Al-Jahdali H, Ahmed A, Al-Harbi A, Khan M, Baharoon S, Bin Salih S,
et al. Improper inhaler technique is associated with poor asthma
control and frequent emergency department visits. Allergy Asthma Clin
Immunol. 2013;9(1):8.
2. Baddar S, Jayakrishnan B, Al-Rawas OA. Asthma control: importance
of compliance and inhaler technique assessments. J Asthma.
3. Price D, et al. "Inhaler errors in the CRITIKAL Study: type,
frequency and association with asthma outcomes". Journal of Allergy
and Clinical Immunology: In Practice. 2017;5(4):1071-1081
4. Kappeler D, et al. Lung deposition of fluticasone
propionate/formoterol administered via a breath-triggered inhaler.
Abstract presented at European Respiratory Society (ERS) annual
congress, Milan, Italy 2017 September 9- 13 [PA522]
5. Tuohy J, et al. Plume spray force of three HFA-propelled ICS/LABA
combination inhalers. Abstract presented at European Respiratory
Society (ERS) annual congress, Milan, Italy 2017 September 9- 13
6. Bell D et al. Relative pulmonary bioavailability (BA) of
fluticasone propionate/formoterol (FP/FORM) via pressurised
metered-dose inhaler (pMDI) and a novel breath triggered inhaler
(BTI). Abstract presented at European Respiratory Society (ERS) annual
congress, Milan, Italy 2017 September 9- 13 [PA523]
7. Bell D et al . Systemic bioavailability (BA) and pharmacodynamics
(PD) of fluticasone propionate/formoterol (FP/FORM) via pressurised
metered-dose inhaler (pMDI) or a novel breath-triggered inhaler (BTI).
Abstract presented at European Respiratory Society (ERS) annual
congress, Milan, Italy 2017 September 9- 13 [PA3950]
8. flutiform SmPC
9. European Respiratory Society. The European Lung White Book. 2013.
Available at:
Job code: MINT/RESP-17014
Date of preparation: September 2017

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