Amarin Soars After Vascepa Settlement

Amarin Corporation plc (ADR) AMRN is up more than 7 percent at $1.66 shortly after the opening bell Wednesday.

The rise follows news that settlement terms have been reached regarding a recent litigation against the pharmaceutical company's promotion of its Vascepa® capsules.

According to the press release, "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."

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John F. Thero, Amarin president and CEO, 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."

Court Document

The official "[Proposed] Stipulation And Order Of Settlement" document outlined the following terms:

1. "Defendants agree to be bound by the Courts conclusion that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa®, i.d., to treat patients with persistently high triglycerides, and under Caronia, such speech may not form the basis of a prosecution of misbranding.

2. "Defendants agree to be bound by the Court's conclusion that, based on the information known as of August 7, 2015, the combination of statements and disclosures that Amarin proposes to make to doctors relating to use of Vascepa® to treat persons with persistently high triglycerides, as such communications have been modified in August 7 Order, is truthful and non-misleading.

3. "Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa® remain truthful and non-misleading.

4. "All terms contained herein are to be interpreted consistently with the August 7 Order, and nothing in this Order shall be construed to limit Amarin's constitutional rights to free speech concerning Vascepa®.

5. "In addition to the optional procedures generally available for submitting proposed communications to FDA for comment, Amarin may submit to FDA under the preclearance procedure described in this paragraph up to two proposed communications per calendar year about the off-labeled use of Vascepa® before communicating them in promotion to doctors to determine if FDA has concerns with Amarin's proposed communications. If FDA has concerns with a proposed communication that Amarin submits to FDA under this paragraph, FDA will contact Amarin with its specific concerns or objections within 60 calendar days […]

6. "The parties agree to work in good faith to resolve any dispute on matters arising under this Order."