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Amarin Says REDUCE-IT Results Are Off Limits To Omega-3 Supplement Claims

This article was originally published in The Pink Sheet

Executive Summary

REDUCE-IT results are limited to Amarin's Vascepa "and cannot be extrapolated to omega-3 products that are materially different based on, for example, composition, dosage, and regulatory status," pharma firm says in complaints against Coromega and Omax. Amarin seeks to stifle the omega-3 supplement firms despite First Amendment argument it made in successful litigation against FDA to make truthful statements about its products even though the information is not approved by the agency.

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Omega-3 Marketers Back Down On Comparisons To Amarin's Vascepa

Coromega Health and Omax will issue press releases explaining that the Amarin study each firm noted in previous releases was not relevant to omega-3 supplements. Releases subject to publication within three days of each settlement's finalization include six mentions of Amarin's Rx prescription triglyceride-lowering fish oil, Vascepa.

'That's Huge, Folks': Amarin's Vascepa Cuts CV Risk By 25% On Top Of Statins

Cardiovascular outcomes data exceeded expectations for the fish oil pill, vindicating Amarin, which has fought long and hard for Vascepa's place in the CV disease prevention market. A filing based on REDUCE-IT is expected in early 2019.

DoJ Maintains Amarin 'Misplaced' Its Omega-3 Unfair Trade Argument

In an amicus opposing Amarin's petition in federal court for an order that the US ITC investigate its fair trade complaint targeting certain omega-3 oil ingredients, DoJ says the drug firm is attempting private enforcement of the FDC Act. The act "commits enforcement exclusively to the federal government to ensure that complex enforcement decisions are made with the benefit of FDA's scientific and regulatory expertise," DoJ argues.

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