SKP17 Jul 2012 08:05
flutiform® Receives Regulatory Approval in Germany
Launch Anticipated Later This Year
LONDON, UK, 17 July, 2012 - SkyePharma PLC (LSE SKP) today announces that the regulatory authority in Germany, Bundesinstitut für Arzneimittel und Medizinprodukte (BfARM), has granted marketing authorisation for flutiform®, a combination product for the treatment of asthma. The launch of flutiform® in Germany is expected to take place later this year.
This approval follows the European Commission's decision, announced on 3 July 2012, to adopt a legally-binding decision in favour of the granting of marketing authorisations for flutiform®. Following the European Commission's decision the 21 member states in the decentralised procedure (DCP) are required to grant national marketing authorisations or approvals consistent with the decision.
Approval has already been granted in Cyprus. It is anticipated that further national marketing authorisations 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. The Group's development, marketing and distribution partner, Mundipharma International Corporation Limited, aims to launch flutiform® in each country through its network of independent associated companies as soon as possible once national approvals are granted and, where required, reimbursement confirmed.
A milestone of €4.0 million is due to SkyePharma once flutiform® has been launched in Germany. Half of this amount will be allocated as prepayments of the Paul Capital Note.