UK drug delivery specialist SkyePharma and partner Mundipharma are celebrating after the European Commission approved their combination asthma drug Flutiform, setting up launches of the product across the EU in the second half of 2012.
The approval comes after a long regulatory route for Flutiform (fluticasone/formoterol) that saw the application referred to the European Medicines Agency (EMA) after EU member states were unable to agree on approval via the decentralised procedure.
The referral had prompted speculation that Flutiform's EU launches could be delayed by several months, but in fact the rapid review by the EMA means it has only been delayed by a few weeks.
Meanwhile, in 2010 the FDA rejected SkyePharma's application for Flutiform as a treatment for asthma, asking for additional clinical studies on dosing that have substantially delaying its approval in the US. That delay cost the UK firm a marketing alliance for the drug with Abbott Laboratories.
Now, with EU endorsement in place, Mundipharma plans to move ahead with launching the product "as soon as possible through its network of independent associated companies once national approvals are granted and reimbursement confirmed".
Shares in SkyePharma climbed more than a third as the news broke yesterday but fell back a little to close up 25 per cent higher at 98 pence.
"To get a product of this complexity through to approval has been an immense achievement by SkyePharma and our partner Mundipharma," said chief executive Peter Grant, who took over the helm of the company earlier this year upon the resignation of former CEO Axel Mueller.
Skyepharma stands to earn milestones of up to €15m in instalments as the product is launched in major European markets, as part of a €73m deal signed with Mundipharma, with another €40m available based on sales performance. The company has already received around €18m in upfront and development milestones.
Mundipharma has marketing rights to Flutiform in the EU, as well as most other territories outside Japan and the Americas.