Amarin Corporation plc (ADR) (NASDAQ:AMRN) announced settlement terms have been reached among the parties to resolve the Amarin First Amendment litigation (Amarin Pharma, Inc. et al. v. FDA et al., No. 15-3588 (S.D.N.Y. May 7, 2015)). Under the terms, the U.S. Food and Drug Administration (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. Amarin’s expanded promotion of Vascepa, initiated following the August 2015 judicial declaration, continues as planned.
“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,” stated John F. Thero, president and chief executive officer of Amarin. “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.”
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, 2015declaration 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. (Original Source)
Shares of Amarin are up nearly 2.5% in after-hours trading. AMRN has a 1-year high of $3.33 and a 1-year low of $1.24. The stock’s 50-day moving average is $1.43 and its 200-day moving average is $1.86.
On the ratings front, Amarin has been the subject of a number of recent research reports. In a report issued on February 26, H.C. Wainwright analyst Andrew Fein reiterated a Buy rating on AMRN, with a price target of $10, which implies an upside of 536.9% from current levels. Separately, on December 9, Oppenheimer’s Akiva Felt assigned a Hold rating to the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Fein and Akiva Felt have a total average return of -2.5% and -1.8% respectively. Fein has a success rate of 43.6% and is ranked #2989 out of 3698 analysts, while Felt has a success rate of 32.0% and is ranked #3119.
Amarin Corp PLC is a biopharmaceutical company with expertise in lipid science. The Company is engaged in commercialization and development of therapeutics to improve cardiovascular health.