UK drugmaker SkyePharma will be breathing a massive sigh of relief after finally winning European approval for its asthma drug Flutiform, news which sent its share price skywards.
The company's stock leapt more than 30% as it emerged that the European Commission has followed the advice of the European Medicine's Agency's Committee for Medicinal Products for Human Use, which recommended approval of Flutiform (fluticasone and formoterol) for asthma back in April.
Flutiform combines fluticasone propionate (fluticasone), an inhaled corticosteroid, and formoterol fumarate (formoterol), a long-acting beta agonist, in a single aerosol inhaler using SkyePharma's proprietary SkyeDry technology.
The news will be particularly sweet for the firm as the drug's marketing application was passed to the EMA last year after member states failed to reach a unanimous decision through the decentralised procedure, with one country disagreeing with the positive benefit/risk assessment initially made by reference state the United Kingdom.
Flutiform has also had trouble elsewhere, with the US Food and Drug Administration issuing a 74-page complete response letter on its marketing application in June 2010, meaning additional clinical work for extra data on dosing, thereby substantially delaying its approval there and costing the firm its marketing agreement with Abbott.
For sale in 21 countries
The EC's move to approve the drug means that all the 21 member states in the decentralised procedure are now required to grant national marketing authorisations or approvals, which some are expected to do in as little as one to three months.
In other countries, national pricing and reimbursement negotiations are needed before Flutiform can hit pharmacy shelves, and SkyePharma's development, marketing and distribution partner Mundipharma is now waiting in the wings to launch the drug as soon as possible once these factors are settled.
According to IMS data, the preventative asthma/COPD European market size in 2010 was around £5.5 billion, with a four-year compound annual growth rate of 6.6%. With preventative asthma treatments comprising well over half this market, there is certainly potential for Flutiform to make its mark.