Amarin Pharma sues omega-3 supplement companies for allegedly using drug firm’s trial to market supplements

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Amarin Pharma Inc. (Dublin, Ireland), maker of high-concentration EPA-only omega-3 drug Vascepa, has filed false advertising lawsuits against two omega-3 dietary supplement manufacturers: Coromega Health Inc. and Omax Health Inc. Amarin contends that these companies used the recently released results of the Amarin’s REDUCE-IT clinical trial to bolster the marketing of their own products. Amarin is stressing that Vascepa is materially different from dietary supplements in composition, dosage, and regulatory status.

Amarin shared topline results from its large-scale Reduction of Cardiovascular Events with EPA Intervention Trial in September. The results show that subjects taking Vascepa (4 g/day) saw a 25% risk reduction in the first occurrence of major adverse cardiovascular events.

“With REDUCE-IT results in hand, Amarin is fully committed to defending the Vascepa franchise against outlier dietary supplement and any drug companies that seek to mislead the public and cardiovascular patients in need by fraudulently leveraging the landmark REDUCE-IT study results or the REDUCE-IT or Vascepa names for profit,” Amarin general counsel Joseph Kennedy said in a statement to Law360. “Amarin is prepared to file multiple new lawsuits should it become aware of any similar claims.”

In the complaint against Coromega, Amarin quotes statements made in a Coromega press release that Amarin says suggest the results of the REDUCE-IT trial reflect positively on Coromega’s own dietary supplements. “Thanks to results from Amarin’s Reduce-It clinical study, we have great news on how omega-3s can positively affect those at risk for heart attack and stroke,” states the press release. This press release is no longer on Coromega’s website.

In their complaint against Omax, Amarin accuses the company of making similar statements in one of their press releases. “Today, Amarin released the long-awaited results of the Vascepa® (icosapent ethyl) REDUCE-IT trial, further validating Omax3®'s 10-year position, that high-concentrate omega-3 fatty acids have a profound and lasting effect on cardiovascular health,” stated Omax in a press release celebrating its 10-year anniversary.

Amarin is asking for a permanent injunction against the supplement companies, a judgement that the companies violated the Lanham Act and California state law, as well as damages, attorney’s fees, and other relief.

This is not the first action Amarin has taken against omega-3 dietary supplement companies, recently filing a complaint with the International Trade Commission alleging that synthetically  produced omega-3s predominantly composed of EPA should not be considered dietary supplements.