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Investors Still Waiting for Decision on Amarin Fish-Oil Drug Exclusivity

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Since Vascepa's approval in July, there has been much guessing: Will the heart treatment get added market protection as an innovative new medicine?

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MINYANVILLE ORIGINAL Since Amarin (NASDAQ:AMRN) won US approval for its fish-oil heart drug in late July, there have been two topics of intense interest surrounding the company: Will it be taken over and will the new heart medicine, Vascepa, win a coveted protection for added market exclusivity? Investors are still waiting for answers.

Amarin CEO Joseph Zakrzewski has said a takeover of the company is one of three paths for the company as it looks to launch Vascepa early next year. The drug is a pure fish-oil treatment -- more potent than over-the-counter products -- aimed at lowering triglycerides, a type of fat, in blood for better heart health.

The other focus for investors in recent months has been whether Amarin's treatment will win the designation of New Chemical Entity, or NCE, from the US Food and Drug Administration. The designation is a reward to drug makers for innovative new medicines and it carries a coveted five years of market exclusivity. Amarin has said it made a strong argument for the designation. It also said that it expects to receive three years of exclusivity if the five-year award is not granted.

"A determination has not yet been made regarding Vascepa," FDA spokeswoman Morgan Liscinsky said in an email Friday. What's more, she says she has no sense of timing for a decision.

Dublin-based Amarin's US shares dropped more than 3% Friday afternoon to $10.86. The stock is down 11% in the past three months.

The FDA has delayed a decision on the NCE matter, but Amarin noted in a US Securities and Exchange filing last week that the FDA usually files notices of such decisions in the middle of the month. (As of early afternoon Friday, there was still no word on a ruling.) Amarin is still being cautious about its chances. According to the company's filing, the FDA has actually made an initial determination, but has not shared that information with the company. Here's what the company says in its SEC filing:

Since prior to FDA approval of the Vascepa new drug application, we have had an active dialogue with the FDA related to our marketing exclusivity request for Vascepa, which requested NCE status for Vascepa. In recent months, we have repeatedly followed up with the FDA seeking a determination. While we continue to believe our arguments in support of an NCE determination for Vascepa are strong, the FDA may not agree with our arguments. Based on our discussions with the FDA, we do not know what determination the FDA will reach regarding the pending exclusivity request for Vascepa or when the FDA will make such determination. We have been informed by [the] FDA that the FDA has drafted a proposed response letter to our exclusivity request, that such draft response letter has been circulated internally at the FDA for comment and the FDA has been considering the issue actively. However, we have not been informed of the content of the FDA's draft response and cannot, based on our communications with the FDA, make a reliable prediction as to when the FDA will communicate a determination on the matter.

Amarin's Vaxcepa would compete with Lovaza, a drug made by GlaxoSmithKline (NYSE:GSK) and Abbott Laboratories' (NYSE:ABT) Tricor and Trilipix.

As for a takeover, a recent published report identified AstraZeneca (NYSE:AZN) and Teva Pharmaceutical Industries (NYSE:TEVA) as potential buyers. However, the NCE market exclusivity question likely needs to be answered first.

Twitter: @brettchase

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No positions in stocks mentioned.
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