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Investor Relations / Vascepa® (Icosapent Ethyl) Showed Reductions in Potentially Atherogenic Lipid and Inflammatory Markers in Statin-Treated Patients with Reduced Kidney Function and Persistent High Triglycerides

Apr 12, 2018

Vascepa® (Icosapent Ethyl) Showed Reductions in Potentially Atherogenic Lipid and Inflammatory Markers in Statin-Treated Patients with Reduced Kidney Function and Persistent High Triglycerides

BEDMINSTER, N.J. and DUBLIN, Ireland, April 12, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular (CV) health, announced the presentation of two posters this week at the National Kidney Foundation 2018 Spring Clinical Meetings in Austin, TX, April 10-14, 2018. These analyses highlight the need for further research in patients with reduced kidney function in conjunction with diabetes mellitus or ongoing inflammation, as denoted by elevated high sensitivity C-reactive protein (hsCRP) levels, and persistent high triglycerides (TG) despite statin therapy due to the association with increased cardiovascular disease (CVD) risk.

The poster titled "Icosapent Ethyl Reduces Potentially Atherogenic Lipid and Inflammatory Markers in High-Risk Statin-Treated Patients With Persistent High Triglycerides, eGFR < 90 mL/min/1.73 m2, and Diabetes Mellitus" showed that, consistent with overall ANCHOR study results, compared with placebo, icosapent ethyl (IPE) 4g/day significantly decreased the primary endpoint of triglycerides (TG) (−19.7%; P < 0.0001) and other lipids without increasing LDL-C. Apolipoproteins and markers of oxidation and inflammation were significantly improved. This poster was authored by: Harold M. Szerlip, MD, Baylor University Medical Center Dallas, TX; Krishnaswami Vijayaraghavan, MD, Abrazo Arizona Heart Hospital, Phoenix, AZ; Christie M. Ballantyne, MD, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, TX; Harold E. Bays, MD, Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY; Craig Granowitz, MD, PhD, Ralph T Doyle, Rebecca A. Juliano, PhD, & Sephy Philip, RPh, PharmD, Amarin Pharma, Inc., Bedminster, NJ.

The poster titled "Icosapent Ethyl Reduces Potentially Atherogenic Lipid and Inflammatory Markers in High-Risk Statin-Treated Patients With Persistent High Triglycerides, eGFR < 90 mL/min/1.73 m2, and Elevated High-Sensitivity C-Reactive Protein ≥2.0 mg/L" showed that, consistent with overall ANCHOR study results, in statin-treated patients with reduced kidney function and elevated high-sensitivity C-reactive protein (hsCRP) with persistent high TG, IPE 4g/day reduced TG and other potentially atherogenic and inflammatory markers without raising low-density cholesterol vs. placebo. This poster was authored by: Krishnaswami Vijayaraghavan, MD, Abrazo Arizona Heart Hospital, Phoenix, AZ; Harold M. Szerlip, MD, Baylor University Medical Center Dallas, TX; Christie M. Ballantyne, MD, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, TX; John R. Nelson, MD, California Cardiovascular Institute, Fresno, CA; Craig Granowitz, MD, PhD, Ralph T Doyle, Rebecca A. Juliano, PhD, & Sephy Philip, RPh, PharmD, Amarin Pharma, Inc., Bedminster, NJ.

Both posters reported data from post hoc analyses in statin-treated patients with reduced kidney function and diabetes or elevated hsCRP with persistent high (200-499 mg/dL) TG.  In these patients, prescription pure EPA Vascepa® at 4g/day, compared to placebo, showed reductions in TG and other potentially atherogenic lipid and inflammatory markers.

"More research is needed in elucidating future CV risk in patients with reduced kidney function and high triglycerides despite statin therapy," said Harold M.  Szerlip, MD.  "The REDUCE-IT trial will enroll some patients with characteristics presented in these posters to determine if intervention with high dose, prescription pure EPA will reduce CV events in statin-treated patients with persistent hypertriglyceridemia. I look forward to learning the results of this important study."

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.  Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-pure, 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.

About REDUCE-IT

Amarin's clinical development program for Vascepa includes a trial known as the REDUCE-IT cardiovascular outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT is the first multinational cardiovascular outcomes study evaluating the effect of prescription 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 (150-499 mg/dL). A large portion of the male and female patients enrolled in this outcomes study are anticipated to also be diagnosed with type 2 diabetes. As reported previously, Amarin expects to announce top-line results of this important study before the end of Q3 2018.  The REDUCE-IT trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.

Additional information on 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 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, known in scientific literature as AMR101, has been designated a new chemical entity by the FDA.  Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug's ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels. 

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. 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 Cardiovascular Disease

Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In the United States CVD leads to one in every three deaths - one death approximately every 38 seconds - with annual treatment cost in excess of $500 billion.1, 2

Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease. 3, 4, 5, 6

Leading clinical investigations seeking to address cardiovascular risk reduction beyond lowering LDL-C focus on interrupting the atherosclerotic process (e.g., plaque formation and instability) by beneficially affecting other lipid, lipoprotein and inflammation biomarkers and cellular functions thought to be related to atherosclerosis and cardiovascular events.

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 as well as statements concerning the REDUCE-IT cardiovascular outcomes study. These statements are not promises or guarantees related to the potential for favorable outcomes from the ongoing REDUCE-IT cardiovascular outcomes trial. As disclosed in filings with the U.S. Securities and Exchange Commission, Amarin's ability to effectively develop and commercialize Vascepa will depend in part on its ability to continue to effectively finance its business, efforts of third parties, its ability to create market demand for Vascepa through education, marketing and sales activities, to achieve increased market acceptance of Vascepa, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of Vascepa and to maintain patent protection for Vascepa. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that future legal determinations and interactions with regulatory authorities may impact Vascepa marketing and sales rights and efforts; the risk that Vascepa may not show clinically meaningful effects in REDUCE-IT or support regulatory approvals for cardiovascular risk reduction; and the risk that patents may not be upheld in anticipated patent litigation.  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 Annual Report on Form 10-K.  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 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.

References

1American Heart Association. 2018. Disease and Stroke Statistics-2018 Update.

2American Heart Association. 2017. Cardiovascular disease: A costly burden for America projections through 2035.

3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.

4 Toth PP, Granowitz C, Hull M, et al. High triglycerides increase cardiovascular events, medical costs, and resource utilization in a real-world analysis of statin-treated patients with high cardiovascular risk and well-controlled low-density lipoprotein cholesterol [abstract]. Circulation. 2017;136(suppl 1):A15187.

5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.

6 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014; 384: 626-635.

Amarin Contact Information

Investor Relations:
Elisabeth Schwartz
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com

Lee M. Stern
Trout Group 
In U.S.: +1 (646) 378-2992
lstern@troutgroup.com

Media Inquiries:
Kristie Kuhl
Finn Partners
In U.S.: +1 (212) 583-2791
Kristie.kuhl@finnpartners.com

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