Amarin (AMRN) NCE Delay Could Be Related to Patents

September 11, 2012 10:37 AM EDT Send to a Friend
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MKM Partners commented on Amarin Corporation (NASDAQ: AMRN) Tuesday following another NCE decision delay on Vascepa.

Analyst Jon LeCroy, M.D. said he continues to believe the delay is a mild positive for Amarin for several reasons: "First, if the decision were cut and dry against Vascepa deserving NCE, the FDA would have simply not granted NCE status. Second, the company apparently had insight into the first NCE delay and yet stated that it expected to be granted NCE. Third, the FDA may be waiting for additional granted patents in order to legally support a decision to grant NCE and to fend off potential complaints by GlaxoSmithKline, the marketer of Lovaza."

LeCroy notes five patents for Vascepa have recently been allowed but are not yet issued. "If the FDA is waiting on these patents to be issued, it could explain the continued delays," he states.

"We expect the next Orange Book update to occur around October 12 and, if one or more of the five recently allowed patents are issued by that point, we would expect Vascepa to be granted NCE designation in that update. If none of these patents are allowed before the next update, we could see an additional delay in October."

The firm maintained their Buy rating and price target of $21.50.

For an analyst ratings summary and ratings history on Amarin Corporation click here. For more ratings news on Amarin Corporation click here.

Shares of Amarin Corporation are down 4.5 percent to $13.76.


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