MUNDIPHARMA

The Mundipharma network of independent associated companies today announced that the European Decentralised Procedure (DCP) licence variation application for flutiform ^® , extending the indication to the treatment of asthmatic children, has closed with a positive opinion. flutiform ^® is a combination of fluticasone propionate and formoterol in a single pressurised metered dose inhaler (pMDI), otherwise known as a press and breathe aerosol inhaler. It is now indicated at a dose of two puffs (actuations) 50/5 µg for regular twice-daily, maintenance treatment of asthma in children aged 5 to <12 years when a combination of an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA) is appropriate.¹

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flutiform ^® has been available in Europe for the treatment of asthma in adults and adolescents (≥12 years old) since 2012 and has a tolerability profile supported by extensive clinical evidence and real-world use for six years across Europe and Asia-Pacific regions in this age group.^1,4,5,6,7

“We are delighted that the combination aerosol flutiform ^® has now been licenced for use in children aged 5 to <12 years in addition to the current indication for adolescents and adults,” said Catriona Cutting, Head of Regulatory Strategy, Mundipharma. “Asthma affects all aspects of children’s and their families’ lives and new treatment options for paediatric asthma are still very much needed.”

Asthma is the most common chronic disease in childhood² and represents a major health burden.⁸ Despite the availability of several paediatric treatment options, uncontrolled asthma is still common in children³ and morbidity from the condition is a major health burden for patients, their families and society.⁸ Poorly controlled asthma in children is associated with time off school, exacerbations and days in hospital.⁹ Recent studies suggest that poor asthma control may have a greater impact on children than previously thought, including important long-term consequences such as an increased risk of lifestyle-associated diseases and poorer school performance.¹⁰

“The paediatric licence indication for flutiform ^® is part of Mundipharma’s commitment to provide new treatments to help improve the lives of people affected by asthma,” said Alberto Martinez, President and CEO, Mundipharma International. “The use of this combination is now well established in adults and adolescents, and we are delighted that following this positive opinion we will also be able to offer this combination for the treatment of paediatric patients.”

The licence variation of flutiform ^® for use in children was based on efficacy and safety data from two 12-week paediatric studies, which demonstrated that the treatment administered as two puffs (actuations) of 50/5 μg dose b.i.d., was non-inferior on lung function endpoints to the established combination therapy, fluticasone propionate/salmeterol, and had a similar tolerability profile. In addition, during a 24-week extension phase of one of the studies, lung function improvements compared with baseline were sustained.¹¹ The 24-week extension phase also showed that children receiving flutiform ^® had growth rates and plasma cortisol levels within the normal ranges. A 28-day knemometry study further found that flutiform ^® did not suppress lower leg growth rate compared with baseline.¹¹

flutiform ^® is an easy-to-use inhaler, which can be used effectively with or without a spacer (use of a spacer is advised for children who may find coordination of actuation with inspiration difficult).¹² The recommended dose of flutiform ^® in children is two puffs (actuations) 50/5 µg twice daily (BID).

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Notes to editors:

For medical and pharmaceutical trade media only

For further information please visit:

http://www.mundipharma.com/Press/RespiratoryResources/background

http://www.flutiform.com/medical-media

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, diabetes, 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 global network develops medicines that create value for patients, payers and wider healthcare systems.

For more information please visit: www.mundipharma.com .

About flutiform ^®

In Europe, flutiform ^® is licenced for regular twice-daily, maintenance treatment of asthma in patients aged 5 years and over when use of a combination product (an inhaled corticosteroid [ICS] and a long-acting β2-agonist [LABA]) is appropriate. As of November 2018, it is available in 21 countries across Europe including the UK, Germany, France, Spain and Italy. flutiform ^® is available in 50/5μg strength for children aged 5 to <12 years, in 50/5μg and 125/5μg strengths for adults and adolescents and 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.¹³

® FLUTIFORM is a registered trade mark of Jagotec AG and is used under licence.

References:

¹ flutiform ^® Summary of Product Characteristics

² Lung Health in Europe. Facts and Figures. European Lung Foundation 2013 http://www.europeanlung.org/assets/files/publications/lung_health_in_europe_facts_and_figures_web.pdf

³ Byrne P, et al. The Poorly Explored Impact of Uncontrolled Asthma. CHEST 2013. 143(2) 511-523

⁴ 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

⁵ 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

⁶ Bodzenta-Lukaszyk A, Pulka et al. Efficacy and safety of fluticasone and formoterol. Respir Med J. 2011;105(5):674-82

⁷ 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

⁸ European Respiratory Society. Childhood asthma. The European Lung White Book. 2013

⁹ Asher, et al. Global burden of asthma among children. Int J Tuberc Lung Dis 2014. 18(11):1269–1278

¹⁰ Pedersen S. Asthma control in children: Is it important and can we measure it? Paediatr Respir Rev  2016; 17:36-8. doi: 10.1016/j.prrv.2015.08.009. Epub 2015 Oct 31. https://www.ncbi.nlm.nih.gov/pubmed/26531216

¹¹ Wolthers O, et al. Short-Term Growth During Treatment with Inhaled Fluticasone Propionate/Formoterol, Fluticasone and Beclomethasone Treatment 2017. J Aerosol Med Pulm Drug Deliv. 2017 Oct;30(5):373-380

¹² GINA, Global Strategy for Asthma Management and Prevention 2018

¹³ Raimundo K, et al. Relationships between asthma control, productivity and health outcomes in a US survey. European Resp J 2016 48: PA4219; DOI: 10.1183/13993003.congress-2016.PA4219

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Contact:

Tiffany Fretwell Communications Lead, Mundipharma International Ltd E-mail: Tiffany.Fretwell@mundipharma.com Tel: +44 (0) 7773 199 422 or Nicola Lilley Account Director, Havas SO E-mail: Nicola.Lilley@HavasSO.com Tel: +44 (0) 7983 128 712