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SKP updates on breath-actuated version of flutiform

30 March 2016 09:18

Skyepharma 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.

At 9:18am:

(LON:SKP) SkyePharma PLC share price was +2.63p at 456.38p

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