Amarin Corp. (AMRN), maker of the blood-fat drug Vascepa, fell the most in two weeks after the company said U.S. regulators hadn’t determined whether to grant the medicine five-year marketing exclusivity.
Amarin dropped 5.6 percent to $11.20 at the close in New York, for the biggest decline since Sept. 24. The Dublin-based company’s American depositary receipts have increased 50 percent this year.
Vascepa, which aims to reduce high levels of triglycerides that can contribute to heart attack and stroke, was approved in July. The Food and Drug Administration still hasn’t decided whether to grant the drug “new chemical entity” marketing exclusivity, Amarin said in a regulatory filing, citing a conversation yesterday with the regulator.
“While Amarin continues to believe its arguments in support of an NCE determination for Vascepa are strong, the FDA may not agree with Amarin’s arguments,” the company said in the filing. “Amarin can make no assurance that Vascepa will be granted NCE exclusivity, or that the FDA will make a determination in a timely manner.”
Amarin said it expects to get three-year marketing exclusivity if the FDA decides against five years.
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