SOURCE: Amarin Corp. Plc

Amarin

May 20, 2016 10:50 ET

Vascepa® (Icosapent Ethyl) Showed Significant Reductions in Key Lipid Parameters in Subgroup of Women With Very High Triglyceride Levels

BEDMINSTER, NJ and DUBLIN, IRELAND--(Marketwired - May 20, 2016) - Amarin Corporation plc (NASDAQ: AMRN) today announced the presentation of a poster at the annual meeting of the National Lipid Association (NLA) further characterizing the efficacy and safety of Vascepa® (icosapent ethyl) in women with very high triglyceride levels.

The poster (#164), titled "Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women With Very High Triglyceride Levels: Results From the MARINE Study," was presented on May 20, 2016. Researchers observed that compared to placebo, Vascepa administered at 4 g/day significantly reduced triglyceride (TG), non-HDL-C, and total cholesterol (TC) levels without increasing LDL ("bad") cholesterol in women with very high TG levels (≥500 and ≤2000 mg/dL). The analysis was led by Lori Mosca, MD, MPH, PhD, Professor of Medicine Emerita and Center Director of the American Heart Association Go Red for Women Research Network at Columbia University Medical Center, New York.

"It is important to generate data that address the specific needs of women, especially in fields where the data could prove useful to patient care," said Dr. Mosca. "The findings presented today, although taken from a small study sample population of women, are encouraging because the efficacy and safety of Vascepa 4 g/day were consistent with the overall MARINE results, which included 229 patients. It is vitally important to evaluate both potential benefits and side effects of therapies in women and not assume results from men are similar in women."

The clinical implications of lowering triglycerides with Vascepa 4 g/day are being investigated in the REDUCE-IT cardiovascular outcomes study of statin-treated women and men with persistent elevated TG levels.

The MARINE study and post-hoc analysis were sponsored by Amarin and were not affiliated with or funded by the American Heart Association (AHA) or the AHA Go Red for Women Research Network.

About the Presented Research

Dr. Mosca's analysis was based on a subgroup of 36 women in the MARINE trial, a study designed to determine the effects of pure EPA prescription therapy (Vascepa) on patients with severe hypertriglyceridemia, including those who were also receiving statin therapy. The 12-week, double-blind, phase 3 MARINE trial included patients (n=229) with TGs between 500 mg/dL and 2000 mg/dL. Statin treatment was not mandated as part of the study's inclusion criteria, but was used as a stratification factor. The subgroup analysis presented at NLA evaluated the efficacy of Vascepa on TG levels, lipid and lipoprotein parameters, and EPA concentrations among the subgroup of women (92% white, mean age 59 years) that were receiving either Vascepa 4 g/day (n=18; 6 on statins) or placebo (n=18; 3 on statins).

The analysis showed that, compared to placebo, Vascepa significantly reduced TGs (−23%; P=0.03), non-high-density lipoprotein cholesterol (−16%; P=0.008), and total cholesterol (−15%; P=0.002) levels without an increase in LDL-C levels (−12%; P>0.05).

As with many subgroup analyses, a limitation is the small sample size, but the results are nonetheless suggestive of complementary beneficial changes in TG levels and lipid and lipoprotein parameters compared with placebo. The efficacy and safety of Vascepa 4 g/day in women were consistent with the overall MARINE results.

Amarin's clinical development program for Vascepa includes a trial known as REDUCE-IT, the first multinational cardiovascular outcomes study evaluating the benefit of pure EPA therapy or any triglyceride lowering therapy as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels (200-499 mg/dL). Amarin recently announced that it has achieved its target enrollment of 8,000 patients for the trial and that an interim efficacy analysis by the independent Data Monitoring Committee of the REDUCE-IT trial is expected in September or October 2016.

Additional information on MARINE, REDUCE-IT and Amarin's other clinical studies of Vascepa can be found at www.clinicaltrials.gov.

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 retrospective sub-set analyses, 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 in small sample sizes may not be predictive of future results in larger studies 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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