Update on breath-actuated version of flutiform

Breath-actuated version of flutiform® accepted for review in Europe

flutiform® K-Haler® submitted for treatment of adolescents and adults with asthma

LONDON, UK, 30 March, 2016 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug development company, today announces that its partner, Mundipharma, has received confirmation that its marketing authorisation application for a breath-actuated version of flutiform® has been accepted for review in Europe. Mundipharma has submitted a file to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the approval of flutiform® K-Haler® (a breath-actuated version of flutiform®) in the treatment of asthma in adults and adolescents where the use of a combination product (an inhaled corticosteroid and a long-acting β2-agonist) is appropriate. The file will be reviewed through the European decentralised procedure.

The breath-actuated version of flutiform® utilises Mundipharma's novel and proprietary K-Haler® device. If approved and launched, Skyepharma will be eligible for revenues on this product from royalties, milestones and filled-canister supply on a similar basis as for flutiform®.

K-Haler® is a novel pMDI (pressurised metered dose inhaler) device which has a simple breath-activated mechanism. It has been designed to make it easier for patients to use correctly. Incorrect inhaler technique coupled with poor adherence to therapy are considered common causes of uncontrolled asthma.1 2

Antony Mattessich, Managing Director, Mundipharma International, said:

"The regulatory submission for flutiform K-Haler demonstrates our continued commitment to improve outcomes for patients with asthma by expanding our portfolio. We believe the K-Haler device offers potential advantages over standard press-and-breathe inhalers for certain groups of patients. We look forward to working with European regulators on the approval process for the flutiform K-Haler, which could offer an additional option for patients and clinicians in the treatment of asthma."

Peter Grant, Chief Executive Officer of Skyepharma, commented: 

"flutiform K-Haler has been designed to build on the success of flutiform in the treatment of asthma, and its development has demonstrated Mundipharma's strong commitment to expanding the flutiform franchise. Skyepharma has worked closely with Mundipharma in this development which we believe is an important potential extension of the flutiform range." 

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About flutiform®

In Europe, flutiform® is 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.

About Skyepharma

Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products. The Group is eligible for revenues from 16 approved products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses. The products developed by the Group are marketed throughout the world by big pharma as well as speciality pharmaceutical companies. For more information, visit www.skyepharma.com 

About Mundipharma

The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. The Mundipharma network has a presence in 51 countries with more than 7,800 employees across the world. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of pain management, oncology, respiratory and inflammatory conditions.

Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers important treatments to meet the most pressing needs of patients, healthcare professionals and health systems worldwide. For more information, visit: www.mundipharma.com.

1. Haughney J et al. Respir Med 2008;102:1681-93

2. Chrystyn H, Price D, et al. Prim Care Respir J 2009;18:243-9