Amarin had filed lawsuits against two companies marketing omega-3 dietary supplements: Coromega and Omax, alleging that both companies were engaged in unfair trade practices by marketing their products in such a way that they were compared to Amarin’s EPA-only drug Vascepa.
The original Lanham Act-based lawsuits were filed in two different districts in California. Omax Health makes conventional omega-3 supplements, while Coromega markets a line of emulsified omega-3s products.
In both cases, Amarin, which is based in Ireland, alleged that the defendants had improperly used the results of Amarin’s REDUCE-IT clinical trial. This trial, which was done on a 4 g dose of Amarin’s drug Vascepa, was allegedly used by the defendants to bolster the marketing of their own dietary supplements.
The results of Amarin’s trial, which included more than 8,000 patients and stretched over 8 years, were published in the New England Journal of Medicine late last year. According to the paper, the trial showed an approximately 25%, reduction in the risk of major adverse cardiovascular events (a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization) in at-risk patients after statin therapy.
Co-opting of science alleged
The results of the scientific trial were heralded as good news by the dietary supplement industry, but Amarin alleged that the two defendants did more than merely applaud the outcome.
According to the complaints, the defendants used the results of these trials to market their own dietary supplements. In the complaints, Amarin quoted marketing statements taken from press releases from the two companies. The alleged quotes are taken from the complaints, as the offending press releases appear to have been removed from the company’s websites.
In the case of Omax, the company purportedly said: “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 omega3 fatty acids have a profound and lasting effect on cardiovascular health.”
The offending statement from Coromega that was offered as evidence in the complaint read: “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.”
In the settlement announced yesterday, Coromega has agreed to not:
Suggest that the REDUCE-IT study (or any other Amarin study of Vascepa) implies use of its omega-3 dietary supplements products would have similar results;
Make any statements regarding the comparability, substitutability, or superiority of the company’s omega-3 product to Vascepa; and
Claim that its omega-3 dietary supplements product lowers or reduces high triglycerides.
“This settlement is a win for both Amarin and the public,” said Joseph Kennedy, Amarin’s executive vice president and general counsel. “The required corrective statements reiterate the unique nature of Vascepa and correct the false claims that led consumers away from appropriate medical attention for the treatment of cardiovascular disease, the number one killer in the United States. Amarin remains fully committed to defending the Vascepa franchise against companies that fraudulently leverage the landmark REDUCE-IT study results for profit.”
Amarin announced it has also reached a settlement with Omax, although details were not available at publication time.
"As a small business, litigation with a large pharmaceutical company distracts us from our long term goal of bringing science-based health and wellness products to our customers. We are pleased that we were able to come to an agreement with Amarin, so we can continue to focus on developing new innovations, including our growth into hemp derived CBD products," said Omax CEO Kristin Chadwick.
Coromega was also contacted for comment but did not respond in time for publication.