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Amarin Corp. plc, an Irish company with research headquarters in Groton, has been awarded three-year marketing exclusivity for its heart drug Vascepa, another disappointment for the biotech and its investors who had hoped regulators would approve five-year patent protection.
"Amarin is reviewing the FDA's reasoning for granting Vascepa three-year, rather than five-year, exclusivity, and evaluating whether to challenge the decision," John Thero, president and chief executive of Amarin, said.
The U.S. Food and Drug Administration ruling, released late last week by Amarin, would extend Amarin's exclusive right to market Vascepa until July 26, 2015. The FDA approved Amarin's fish-oil pill to fight blood fats known as triglycerides in July 2012.
Amarin had sought so-called new chemical entity status, but the FDA instead designated Vascepa as a new product. But as noted by Adam Feuerstein, a blogger on thestreet.com, Amarin might be able to extend the life of its patent through legal means.
Amarin's share price finished the day at $1.89, up about 1.6 percent on the day. The price had fallen more than 3 percent Friday after the FDA decision was announced, and is more than 80 percent lower than when Vascepa first received approval.
"Amarin will almost certainly sue any generic drug maker who files and will receive an automatic 30-month extension of Vascepa exclusivity," he said in his blog Monday. "Amarin believes patents on Vascepa, some of which extend out to 2030, protect the product beyond the expiration of market exclusivity."
But competitors may not be in the offing anyway, considering lackluster sales of Vascepa so far. As noted by Feuerstein, Amarin is expected to report Thursday that its heart pill saw only about $27 million in sales last year, and that is expected to grow to only $115 million by next year - a far cry from the billion-dollar market that was foreseen after FDA approval.
The problem has been Amarin's inability to get the FDA on board with approving Vascepa for a wider group of patients with triglyceride counts a bit below the most dangerous level.
"Without an expanded label, Amarin is forced to market Vascepa only to patients with extremely high triglycerides - a task the company isn't doing very well," Feuerstein said.