Generic Lovaza Draft Guidance doesn't Prevent NCE for Amarin's (AMRN) Vascepa - Analyst
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Price: $6.89 -1.29%
Rating Summary:
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Today's Overall Ratings:
Up: 13 | Down: 28 | New: 14
Rating Summary:
9 Buy, 3 Hold, 0 Sell
Rating Trend:
Down
Today's Overall Ratings:
Up: 13 | Down: 28 | New: 14
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Analysts at MKM Partners said FDA draft guidance for generic Lovaza, stating that the Omega-3-Acid Ethyl Esters (Lovaza) USP monograph defines the active pharmaceutical ingredient (API) for Lovaza as composed of seven individual omega-3-acid ethyl ester components, does not preclude Amarin's (NASDAQ: AMRN) Vascepa from qualifying for NCE exclusivity.
"While EPA, the main component of Vascepa, is included as one of the seven API components, we do not think that this precludes Vascepa from qualifying for NCE exclusivity," analyst Jon LeCroy, M.D. states. "The case on whether to grant Vascepa NCE status is not cut and dry and the FDA has twice delayed its formal determination of NCE status."
LeCroy continues to expect the FDA to grant Vascepa NCE status in the next update of the Orange Book, expected around October 12.
MKM Partners maintained its 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 are down 6 percent Monday to $12.57.
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"While EPA, the main component of Vascepa, is included as one of the seven API components, we do not think that this precludes Vascepa from qualifying for NCE exclusivity," analyst Jon LeCroy, M.D. states. "The case on whether to grant Vascepa NCE status is not cut and dry and the FDA has twice delayed its formal determination of NCE status."
LeCroy continues to expect the FDA to grant Vascepa NCE status in the next update of the Orange Book, expected around October 12.
MKM Partners maintained its 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 are down 6 percent Monday to $12.57.
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