Press release content from Globe Newswire. The AP news staff was not involved in its creation.
PRESS RELEASE: Paid content from Globe Newswire
Press release content from Globe Newswire. The AP news staff was not involved in its creation.

Amarin Corporation plc (NASDAQ:AMRN) Stock Trading Halted Today for Scheduled FDA Advisory Committee Review of sNDA Seeking New Indication for Vascepa® (Icosapent Ethyl) to Reduce the Risk of Major Adverse Cardiovascular Events Based on Landmark REDUCE-IT® Cardiovascular Outcomes Study

November 14, 2019 GMT

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that NASDAQ has halted trading of the company’s shares. The U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), as previously scheduled and announced, is meeting today to openly discuss the company’s supplemental New Drug Application (sNDA) seeking a new indication for Vascepa® (icosapent ethyl) to reduce the risk of major adverse cardiovascular events based on the landmark REDUCE-IT® cardiovascular outcomes study.

The Advisory Committee meeting is scheduled for 8:00 a.m. ET. The briefing materials can be found on the FDA website at https://www.fda.gov/advisory-committees/november-14-2019-meeting-endocrinologic-and-metabolic-drugs-advisory-committee-meeting-announcement. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA’s review of Vascepa’s supplemental New Drug Application is December 28, 2019.

The EMDAC reviews and evaluates data concerning the effectiveness and safety of marketed and investigational human drug products under review at the Division of Metabolism and Endocrinology Products at FDA and makes appropriate recommendations to the division. The FDA is not bound by the recommendations of an advisory committee.

About Amarin

Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is Amarin’s first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin’s commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East. For more information about Amarin, visit www.amarincorp.com.

Availability of Other Information About Amarin

Investors and others should note that Amarin communicates with its investors and the public using the company website http://www.amarincorp.com/ ), the investor relations website ( http://investor.amarincorp.com/ ), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Amarin Contact Information

Investor Inquiries:Elisabeth SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315 investor.relations@amarincorp.com

Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992 lstern@soleburytrout.com

Media Inquiries:Gwen FisherCorporate Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735 pr@amarincorp.com