A dietary supplement manufacturer sued by Amarin—a biopharmaceutical company focused on developing products to improve cardiovascular health—has agreed to refrain from making certain advertising statements after being accused of using results from a landmark study to make false and deceptive claims.
Under a settlement agreement reached with Amarin, The Coromega Company, Inc. (Coromega) agreed to not make advertising claims that compare its products to Vascepa, Amarin announced in an emailed statement.
Vascepa is an FDA-approved prescription drug for the treatment of patients with very high triglyceride levels. The active ingredient is the omega-3 fatty acid eicosapentaenoic acid (EPA) in ethyl-ester form.
Under the settlement agreement with Amarin, Coromega agreed to refrain from making advertising claims that reference a landmark clinical study conducted by Amarin or relate to the treatment of cardiovascular disease, the biopharmaceutical company said. Coromega “also acknowledged that as a general matter under federal law, dietary supplements may be lawfully marketed to supplement the diet, but they cannot be lawfully marketed to treat, mitigate or prevent disease, such as cardiovascular disease [CVD],” Amarin disclosed.
Joseph Kennedy, executive vice president and general counsel of Amarin, described the settlement as a “win” for the public and his company.
“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,” Kennedy said in a statement.
He added, “Amarin remains fully committed to defending the Vascepa franchise against companies that fraudulently leverage the landmark REDUCE-IT study results for profit. We’ve got a team of litigators on speed dial ready to file multiple new lawsuits should we become aware of any similar fraudulent claims.”
In 2018, Amarin Corp. (NASDAQ: AMRN) announced the results of a clinical study it said cost more than US$360 million. The REDUCE-IT clinical trial, a study of nearly 8,200 adults with elevated CVD treated with statin therapy, researched the effect of taking Vascepa. The study, Amarin disclosed, found Vascepa reduced by roughly 25 percent the risk of major adverse cardiovascular events in at-risk patients following statin therapy.
According to Amarin, Vista, California-based Coromega subsequently issued a press release that said, in part: “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.”
Coromega did not immediately respond to a request for comment. However, the main page of its website features a “corrective statement” that the settlement agreement required.
“The REDUCE-IT study,” the statement discloses, in part, “was not designed to test the efficacy of any Coromega dietary supplement product.”
Just days after the study’s findings were announced, another dietary supplement company—Omax Health Inc. in Santa Monica, California—issued a press release suggesting the trial’s results supported the efficacy and safety of its nonprescription omega-3 products for curtailing cardiovascular risk in the general public, Amarin alleged.
In October 2018, Amarin filed lawsuits in California against Coromega and Omax, alleging violations of state law and the federal Lanham Act, which protects against unfair competition.
Omax also has reached an accord with Amarin to resolve the ligation. The terms of the agreement weren’t immediately public but were expected to resemble the terms in the settlement agreement between Amarin and Coromega. Tatro Tekosky Sadwick LLP, a Los Angeles-based law firm representing Omax, did not immediately respond to a request for comment.
Amarin has made various moves to protect its investment in Vascepa from encroachment by marketers of dietary supplements. Lately, the company has experienced both success and failure in the courtroom.
Last week, a federal appeals court upheld a decision by the U.S. International Trade Commission (USITC) not to investigate a complaint brought by Amarin against what it described as “synthetically produced omega-3 products" being promoted as dietary supplements. In a statement updated May 2 on its website, Amarin expressed disappointment with the ruling by the U.S. Court of Appeals for the Federal Circuit and said it was "analyzing its options going forward."
In the quarter that ended on March 31, 2019, Amarin reported total revenue of $73.3 million, a 67 percent increase over the same three-month period the prior year. Amarin largely attributed the growth to Vascepa sales.