Re: AMR101 NCE status.

According to CFR 21, "New chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the act."

"Active moiety means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance."

So an NCE is a single chemical species ("drug substance") and not a mixture of compounds ("drug product"). The NCE, consisting of an "active moiety" that gives this compound its activity, plus other parts (esters and salts), confers exclusivity on a drug product because you cannot make the drug product without also creating the NCE.

Pancreatic enzyme mixtures are uncharacterizable mixtures. The FDA decided to grant NCE exclusivity basis based on the assumption that such mixtures contained one or more NCEs.

AMR101 contains ethyl EPA, the "active moiety" of which is EPA. Since ethyl EPA is also in Lovaza, it is not an NCE. Neither Lovaza nor AMR101 is an uncharacterizable mixture. The arguments that provided pancreatic enzymes with exclusivity, are in my opinion, irrelevant here.

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