Circassia Announces Positive Outcome Of European Decentralised Procedure For Approval Of Its Fluticasone Propionate Equivalent Of GlaxoSmithKline’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.

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