Circassia wins EU regulatory boost for asthma generic drug

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has agreed that Circassia's fluticasone propionate pressurised metered dose inhaler (pMDI) “can be approved”, which will allow the issue of a national license to begin and serve as a reference for approval in other European Union member states under the European Decentralised Procedure (EDP).

Circassia's Prosonix subsidiary, which was acquired in June, has developed the drug in collaboration with partner Mylan as a generic equivalent of GlaxoSmithKline's Flixotide pMDI for the preventative treatment of asthma, with the product eligible for direct substitution of Flixotide in all three strengths in applicable EU markets once it gains approval. Flixotide achieved sales of £102m in Europe in 2014 and $930m worldwide.

The approval and subsequent licence receipt will trigger a contingent £30m payment to Prosonix's previous owners.

The FTSE 250 company said the positive regulatory outcome represented an important validation of Circassia's particle-engineering platform, as it was the first ever marketing authorisation application (MAA) for a product using the technology.

"This provides a major competitive advantage for the development of difficult-to-manufacture products, in particular respiratory medicines, which are notoriously challenging," it added.

Chief executive Steve Harris said achieving the positive outcome was a major milestone for Circassia.

"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."

The company noted that the MAA made use of the European regulatory guidelines on orally inhaled products, which permit 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.

Circassia said its particle-engineering technology allowed it to overcome the traditional formulation challenges in the production of respiratory pharmaceuticals and so enabled the first ever such in vitro demonstration in a range of product strengths.

Prosonix's sonocrystallization technologies provide precise control over the physicochemical and aerodynamic properties of respiratory medicines, which enables Cricassia and its partners to develop products that target direct substitution of popular asthma medicines as well as novel combination products and optimized formulations.

Analysts at broker Stifel said the announcement was clearly good news for Circassia and demonstrated the value of the
Prosonix acquisition.

Stifel expect Circassia to announce significant news in the coming months, pointing to a follow-up data from Phase IIb trials into its Ragweed allergy treatment in the new class of allergy therapies – Synthetic Peptide Immuno-Regulatory Epitopes (SPIRE).

Stifel said the "key" news will be Phase III results of Spire trials for its cat allergy SPIRE therapy which it expect to be announced in the second quarter next year.

"Our buy rating is based on the premise that Circassia's allergy immunotherapy portfolio including Cat-SPIRE offers the prospect of transforming the treatment of seasonal and perennial allergies."