Health and Healthcare

Amarin Reaches Settlement Terms With FDA

Chris Lange

Published: March 9, 2016 11:50 am

Last Updated: January 13, 2020 12:10 pm

Amarin Corp. PLC (NASDAQ: AMRN) made some headway in Wednesday’s regular trading session following a settlement with the U.S. Food and Drug Administration (FDA). The company announced that settlement terms have been reached among the parties to resolve the Amarin First Amendment litigation.

Under the terms, the FDA and the U.S. government have agreed to be bound by the August 7, 2015, judicial declaration that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa (icosapent ethyl) capsules.

Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

The key settlement terms include:

• FDA and the U.S. government have agreed to be bound by the court’s earlier conclusions from the August 7, 2015 declaration that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa and that certain statements and disclosures that Amarin proposed to make to healthcare professionals are truthful and non-misleading.
• Amarin bears the responsibility of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.
• The settlement terms are to be interpreted consistently with the August 7, 2015 opinion and order and are not to be construed to limit Amarin’s constitutional rights to free speech concerning Vascepa.
• FDA has agreed to provide Amarin with an optional preclearance provision through 2020 for new off-label claims.
• The parties have agreed to a dispute resolution provision designed to avoid future litigation on matters arising under the settlement order.
• The court would retain jurisdiction over the matter to ensure compliance with and resolve any future dispute arising from the settlement order.

John F. Thero, president and CEO of Amarin, commented:

We are pleased to announce this amicable resolution with and among the physician plaintiffs, FDA and the U.S. government and look forward to continuing to promote Vascepa in a truthful, non-misleading and responsible manner. With more truthful and non-misleading information readily available to healthcare professionals about the potential of Vascepa to improve cardiovascular health, this settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides.

Shares of Amarin were trading up 6.5% at $1.65 on Wednesday, with a consensus analyst price target of $6.50 and a 52-week trading range of $1.24 to $3.33.