Amarin and its omega-3 pill have struck out with the FDA again. The Irish company said today that the agency has again turned down its appeal to reconsider its clinical data it hoped would help it win a label extension for Vascepa, dealing a new blow to its efforts and its financial well being. This FDA first rejected Amarin's request in January.
The market for Omega 3-based prescription drugs was just a one-drug wonder. But now, there are not only two more fish-oil-based brands--Amarin's Vascepa and AstraZeneca's Epanova--but a generic version of Lovaza, too. And all four are looking for their share of a market that is still more potential than actual.
Watch out, GlaxoSmithKline--and Amarin. Teva Pharmaceutical Industries has launched its generic version of Glaxo's fish-oil pill, Lovaza, designed to lower triglyceride levels in patients with cardiovascular disease.
It hasn't been easy being Amarin over the last several months. The Irish drugmaker slammed into one obstacle after another. Read more from FiercePharmaMarketing >>
After a rough go with the FDA sent its shares spiraling downward, Amarin has at last found a partner to help commercialize its fish-oil-derived pill for high triglycerides.
It hasn't been easy being Amarin over the last several months. The Irish drugmaker slammed into one obstacle after another. New chemical entity status for the key ingredient in its cardiovascular drug Vascepa? No, says the FDA. Permission to market the drug to vast numbers of new patients? No again.
Amarin's lawyers were just in court last week suing the FDA for limiting the exclusivity it granted the drugmaker's fish oil pill Vascepa. But the Irish drugmaker hustled them back to court Tuesday, this time to sue AzstraZeneca, which is awaiting FDA approval on its own product for treating super-high cholesterol.
Amarin, which has faced a series of setbacks getting its fish oil pill to market, is lashing out at the FDA for some of its problems, Bloomberg reports.
For Amarin, FDA approval for its drug Vascepa wasn't enough. The company needed more from the agency. For one thing, it needed the FDA to deem Vascepa, a cardiovascular drug derived from fish oil, a New Chemical Entity. That designation comes with 5 years of market exclusivity. Amarin didn't get it.
Amarin's hopes of expanding the label for its omega-3 pill look even bleaker as the FDA has denied the company's appeal to reconsider its clinical data, sending shares down another 25% in premarket trading Tuesday.