SOURCE: Amarin Corp. Plc

Amarin Corp. Plc

May 11, 2016 07:30 ET

Vascepa® (icosapent ethyl) and Eicosapentaenoic Acid (EPA) Data to Be Presented at National Lipid Association 2016 Scientific Sessions

BEDMINSTER, NJ AND DUBLIN, IRELAND--(Marketwired - May 11, 2016) - Amarin Corporation plc (NASDAQ: AMRN) today announced that new data related to Vascepa® (icosapent ethyl) and eicosapentaenoic acid (EPA) will be presented at the upcoming National Lipid Association 2016 Scientific Sessions in New Orleans (May 19-22).

Data will be presented from two posters on Vascepa and an oral presentation on EPA. This includes data from a subgroup of women with very high triglyceride levels from the MARINE trial, a study designed to determine the effects of Vascepa in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, including those who were also receiving statin therapy.

The poster and oral presentations are:

  • Poster Presentation: Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women With Very High Triglyceride Levels: Results From the MARINE Study - (Authors: Lori Mosca, MD, MPH, PhD, Harold E. Bays, MD, Sephy Philip, RPh, PharmD, et. al)
    • NLA Abstract #164; Friday, May 20, 9:25-10:25 a.m. CDT and Saturday, May 21, 9:25-10:00 AM CDT
  • Poster Presentation: Improvements in Carotid Artery Intima-Media Thickness With Icosapent Ethyl in Three Patients With Non-HDL-C ≥130 mg/dL: A Case Series - (Study Authors: Kota J. Reddy, MD, FACC, Sumita Chowdhury, MD, MPH, FACC, MBA)
    • NLA Abstract #167; Friday, May 20, 9:25-10:25 AM CDT and Saturday, May 21, 9:25-10:00 AM CDT
  • Oral Presentation: Eicosapentaenoic Acid (EPA) Reduces Hyperglycemia-Induced Small Dense Low-Density Lipoprotein Oxidation In Vitro in a Manner Distinct from Docosahexaenoic Acid (DHA) - (Study Authors: Samuel C.R. Sherratt, BS, Robert F. Jacob, PhD, R. Preston Mason, PhD)
    • Clinical Lipidology Track; Friday, May 20, 3:10-3:20 PM CDT

About VASCEPA®  (icosapent ethyl) capsules

VASCEPA® (icosapent ethyl) capsules are a single-molecule prescription product consisting of 1 gram of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa is known in scientific literature as AMR101.

FDA-approved Indication and Usage

  • VASCEPA (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
  • The effect of VASCEPA on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information for VASCEPA

  • VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
  • Use with caution in patients with known hypersensitivity to fish and/or shellfish.
  • The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction >3% and greater than placebo.
  • Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
  • In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
  • Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
  • Adverse events and product complaints may be reported by calling
    1-855-VASCEPA or the FDA at 1-800-FDA-1088.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.

About Amarin

Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin's clinical program includes a commitment to the ongoing REDUCE-IT cardiovascular outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-pure, EPA-only, omega-3 fatty acid product available by prescription. For more information about Vascepa, visit www.vascepa.com. For more information about Amarin, visit www.amarincorp.com.

Forward-looking statements

This press release contains forward-looking statements, including statements about the potential efficacy and therapeutic benefits of Vascepa and EPA, including implications about the potential clinical importance of the findings presented. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research on biomarkers thought to be relevant in the treatment of cardiovascular disease, research and development and clinical trial risk generally, including the risk that study results may not be predictive of future results and that studied parameters may not have clinically meaningful effect. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Availability of other information about Amarin

Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), 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 we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

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