Circassia Announces Positive Outcome of European Decentralised Procedure for Approval of Its Fluticasone Propionate Equivalent of GSK’s FLIXOTIDE® pMDI

– Product approvable in all reference product strengths –
– Successful application based on in vitro demonstration of therapeutic equivalence –

Oxford, UK – 24 November 2015: Circassia Pharmaceuticals plc (LSE: CIR) today announces the positive outcome of the European Decentralised Procedure (DCP) for the Company’s fluticasone propionate pressurised metered dose inhaler (pMDI) generic equivalent of GlaxoSmithKline’s FLIXOTIDE® pMDI for the prophylactic treatment of asthma.  Under the DCP, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) acted as the Reference Member State.  The MHRA agrees that the product can be approved and issue of the national licence will now commence.  Based on initial national Marketing Authorisations following the DCP, the product will be submitted under the Mutual Recognition Procedure for approval in other EU Member States.

Direct substitution of Flixotide® pMDI
The Marketing Authorisation Application (MAA) includes all three strengths of fluticasone propionate in which GSK’s FLIXOTIDE® pMDI is available (50µg, 125µg and 250µg per actuation).  Consequently, the product will be eligible for direct substitution of FLIXOTIDE® pMDI in applicable EU markets once approved.

Leveraging EU guidance on in vitro equivalence
The MAA leverages the European regulatory guideline CPMP/EWP/4151/00 Rev. 1 on orally inhaled products that permits the approval of candidates that are therapeutically equivalent to approved treatments on the basis of in vitro demonstration of equivalence only, without the need for clinical data.  The Company believe this has not been achieved previously in a range of product strengths due to the manufacturing and formulation challenges associated with traditional production of respiratory pharmaceuticals.  Circassia’s fluticasone propionate pMDI is based on the Company’s proprietary particle-engineering technology that is designed to overcome these issues.

Validation of Circassia’s technology
The positive regulatory outcome represents an important validation of Circassia’s particle-engineering platform.  This provides a major competitive advantage for the development of difficult-to-manufacture products, in particular respiratory medicines, which are notoriously challenging.

Commenting on the successful regulatory filing, Steve Harris, Circassia’s Chief Executive, said: “Achieving this positive outcome is a major milestone for Circassia, marking the favourable conclusion of the Company’s first ever Marketing Authorisation Application for a product using its particle-engineering technology.  This achievement is also highly significant as it is the first time a marketing application has successfully used in vitro data only to demonstrate therapeutic equivalence for a respiratory product across a range of strengths, avoiding the need for clinical studies.  This positive outcome provides unequivocal validation of Circassia’s novel particle-engineering technology, and as a result we look forward to filing our next respiratory product in 2016.”

Collaboration with Mylan
The product is being developed in collaboration with Mylan NV as part of a previously announced global licensing agreement between Prosonix and Mylan.  Prosonix was acquired by Circassia in June 2015.

– Ends –


Steve Harris, Chief Executive Officer
Julien Cotta, Chief Financial Officer
Rob Budge, Corporate Communications
Tel: +44 (0)1865 405 560

FTI Consulting
Ben Atwell / Simon Conway / Mo Noonan
Tel: +44 (0) 20 3727 1000

About asthma
Asthma is a chronic respiratory disease characterised by recurrent attacks of breathlessness and wheezing.  The World Health Organisation estimates that 235 million people suffer from asthma worldwide and it is the most common chronic disease among children.  Asthma is a major health burden, and its symptoms often cause sleeplessness, fatigue and absences from school and work.  As a consequence, the disease is responsible for significant health costs, with the asthma treatment market estimated at more than $16 billion in 2014 and worldwide FLIXOTIDE® pMDI sales (FLOVENT® pMDI in the United States) accounting for approximately $930 million that year.

About Circassia
Circassia is a world-class specialty biopharmaceutical business focused on allergy and respiratory disease.  The Company has an established commercial infrastructure, marketed products, a pipeline of near-term therapies and a portfolio of next generation treatments targeting multi-$billion market opportunities.  Circassia sells its novel, market-leading products for asthma management directly to allergy / asthma specialists in the United States and Germany.  Its products are also promoted in a number of other countries by the Company’s international network of partners.

Circassia’s broad-based development pipeline includes a range of treatments for allergy and respiratory disease.  Circassia’s most advanced next-generation immunotherapy is currently in phase III testing for cat allergy, and is the first in a new class of treatments, Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs).  Three other SPIREs, targeting house dust mite, ragweed and grass allergies, have completed clinical proof-of-concept phase IIb studies.  Circassia’s lead asthma product targets substitution of GSK’s FLIXOTIDE® pMDI, and UK approval is expected in December 2015.  Circassia anticipates two further product filings by the end of H1 2016, targeting direct substitution of SERETIDE® pMDI and SEREVENT® pMDI.  The Company is also developing a number of novel treatments, including a fixed dose ‘triple’ combination containing an inhaled corticosteroid, long-acting beta agonist and long-acting muscarinic antagonist.

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