Flutiform was referred to the European Medicines Agency (EMA) last year after member states could not reach unanimous agreement on the drug, which will compete with GlaxoSmithKline's Advair and AstraZeneca's Symbicort in the multi-billion dollar respiratory drugs market
A positive opinion from the EMA is usually rubber stamped by the European Commission in a matter of months.
Shares in SkyePharma, which has partnered Mundipharma in developing the drug, more than doubled to 85.5 pence, valuing the group at about 22 million pounds.
"This is the end of a long struggle for the company," said Singer analyst Shawn Manning. "It's highly unlikely that it will get this stamp of approval and not get approved."
He said Flutiform could have sales in Europe of $200 million within five years, assuming it won "a modest" 7 percent share of combination therapy patients.
"We estimate 10 percent will go to SkyePharma, so it's a good solid contributor," he said, adding that the positive opinion also opened the door to markets in Latin America and Canada.
Flutiform is a combination of two commonly prescribed drugs to treat asthma, the corticosteroid fluticasone propionate and the beta-agonist formoterol fumarate, in a metered dose inhaler.
SkyePharma's chief executive Peter Grant said the decision was a strong endorsement of the group's capabilities in developing complex respiratory products.
"It is also good news that we are now on track for a new treatment option to be available for many patients suffering from asthma across Europe," he said.
Earlier on Friday, SkyePharma received a $10 million payment from Pacira Pharmaceuticals following the launch of post-surgical pain drug Exparel in the United States.
(Editing by Hans-Juergen Peters)
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