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Amarin shares fall on drug exclusivity questions

WASHINGTON (AP) — U.S.-traded shares of Amarin Corp. fell Tuesday after the Irish drug developer indicated regulators have still not decided whether to grant its only drug, Vascepa, status that would protect it from generic competition.

THE SPARK: Amarin filed a regulatory filing Monday indicating that the Food and Drug Administration is unlikely to rule this month on whether to grant its drug Vascepa five years of market exclusivity — the standard duration for a first-of-a-kind drug. Vascepa is a prescription form of fish oil designed to lower triglycerides, a type of fat in the bloodstream.

THE BIG PICTURE: The FDA approved Vascepa in July for patients with unusually high levels of triglycerides. It was the first drug to reach the U.S. market for Amarin. However, the agency is still determining whether to grant the pill status as a first-of-a-kind drug that would give it five years of protection from competition. Amarin said in its filing the FDA indicated it would not rule on that decision in the latest issue of the Orange Book, a federal compendium of drug information.

THE ANALYSIS: Roth Capital Partners analyst Joseph Pantginis said the uncertainty will continue to "drive volatility for Amarin." However, he also pointed out that the company has a strong patent position that could protect it from competition, even if FDA does not grant five years exclusivity. Amarin has secured six patents on its drug and has 25 more pending, which will expire no earlier than 2030, according to an investment report. Pantginis maintained a "Buy" rating on the stock with a $26 price target.

SHARE ACTION: Amarin Corporation plc shares fell 63 cents, or 4.4 percent, to $13.78 in afternoon trading. Over the past year, shares have traded between $5.99 and $15.96.

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