The Lanham Act-based lawsuits were filed in two different districts in California against Omax Health and Coromega. Omax Health makes conventional omega-3 supplements, while Coromega markets a line of emulsified omega-3s products.
In both cases, Amarin, which is now 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 reported in late September and will be formally presented this month. According to Amarin, the trial showed an approximately 25%, reduction in the risk of major adverse cardiovascular events (“MACE”) (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 trial were heralded as good news by the dietary supplement industry. But Amarin alleges 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.”
Amarin maintains that the products made by Omax and Coromega are different enough from Vascepa that the results of that trial cannot be extrapolated to the dietary supplements. In both cases, the products also include DHA as well as additional fatty acids and other constituents. Vascepa is a highly purified ethyl ester form of EPA. And the recommended dosages of the products are different as well, Amarin maintained.
Amarin maintains that the products made by Omax and Coromega are different enough from Vascepa that the results of that trial cannot be extrapolated to the dietary supplements.
Alluding to drug trials comes with some risk
Steve Mister, president and CEO of the Council for Responsible Nutrition, declined to comment on the specifics of the two cases. But as a general observation, he offered this:
“I think these two lawsuits, without making any comment on the specific facts here, serve as a good reminder to the industry that trying to co-opt clinical trials on a prescription drug does carry some risk,” he said.
“Clinical drug trials are typically conducted on a diseased population and are looking to treat or cure a disease,” Mister added. “You have to be very careful when using trials with those sorts of outcomes that you might convey to FDA that you are marketing a drug.”
“As a general rule you want to be sure your product matches what is in the clinical trial you are using for substantiation, both the dosage amount and the form of the ingredient. These have some potential implications for everything from vitamin D trials, to clinical trials for probiotics to some clinical trials on herbs,” he said.
Amarin’s past attempts to protect market niche
This is far from the first legal action Amarin has taken in regard to its product. In September of last year the company filed a complaint with the International Trade Commission that alleged that makers of some high purity, high concentration ethyl ester forms omega-3s that contained a high proportion of EPA were violating the company’s patents. The action, which listed such major players as DSM, Marine Ingredients and Croda as defendants, was decried within the dietary supplement industry as an attempt to corner the market for its pharmaceutical.
The ITC declined to hear the case. In December Amarin filed an appeal in an attempt to have a district court judge force ITC to take up the matter. A ruling on that appeal is still pending.
Mister noted that Amarin seemed to be arguing both sides of fence with the addition of the two lawsuits filed this week. In the ITC case, it has alleged that dietary supplement manufacturers were violating its patents, while in the more recent Lanham Act lawsuits it was emphasizing how different the dietary supplements in question are from its drug.
“It is another effort from Amarin to try to carve out a protected niche for their prescription drug in a world where omega-3s are already being sold as dietary supplements,” Mister said.
“I think this puts them in kind of a conundrum,” he said.
Omax Health was unable to respond in time for publication to a request for comment.
Milo Cogan, president of Coromega, had this to say: “We haven’t yet been served with this lawsuit. Our attorneys will review it once received, so until then we don’t have enough information to make a comment.”