The UK regulatory authority, the Medicines and Healthcare product Regulatory Agency (MHRA), has granted marketing authorisation for Flutiform, SkyePharma's combination product for the treatment of asthma. The UK launch is expected to take place later this year.
The UK marketing approval follows the European Commission's decision to back the treatment in July 2012. The EC's decision is binding on the 21 member states in the decentralised procedure (DCP). Marketing approvals have already been granted in Germany, Cyprus, the Netherlands and the Slovak Republic. It is anticipated that further approvals will be granted in some countries shortly. In other countries, negotiations will also be required with national pricing and reimbursement authorities before the product can be made commercially available.
SkyePharma's development, marketing and distribution partner, Mundipharma, aims to launch the product in each country through its network of independent associated companies as soon as possible once national approvals are granted and where required, reimbursement confirmed. Mundipharma's UK independent associate is Napp Pharmaceuticals. A further milestone of EUR 4.0 million is due to SkyePharma once Flutiform has been launched in the UK.