Priority Status granted to Vascepa® by Health Canada Nasdaq: AMRN

BEDMINSTER, NJ, and DUBLIN, Ireland, March 29, 2019 (GLOBE NEWSWIRE) – Amarin Corporation plc (Nasdaq: AMRN), a leading specialty pharmaceutical company in the field of cardiovascular health, announced today that its owner licensee in Canada, HLS Therapeutics Inc. (TSX: HLS), has received formal confirmation from Health Canada that the Canadian regulator has granted priority review status to the next New Drug Submission ("NDS"). Vascepa® capsules (icosapent ethyl). HLS Therapeutics expects to file the NDS in April 2019 in order to obtain authorization to market and sell Vascepa in Canada to reduce the risk of ischemic cardiovascular events in patients treated with statins with high triglycerides and other risk factors.

Priority review status may be granted to regulatory filings in Canada for new therapies that may treat life-threatening serious conditions for which no drug is currently marketed in Canada and for which there is evidence substantial clinical effectiveness of this new treatment. As part of the priority review, the performance goal for the preliminary examination and examination of the original bid is 215 calendar days, compared with 355 days for a standard examination. Therefore, receipt of priority review status could expedite the launch of Vascepa in the Canadian market, if the product was ultimately approved by Health Canada.

Although the NDS includes the results of the REDUCE-IT ™ study on the cardiovascular effects of Vascepa, the review of this regulatory submission in Canada should be independent of the review of Amarin's recent additional drug application filed with of the US Food and Drug Administration regarding Vascepa based on the same results of the clinical study.

"We appreciate HLS Therapeutics' progress in advancing Vascepa in Canada as part of our mission to reduce the number of cardiovascular events in patients around the world," commented John F. Thero, President and Chief Executive Officer. from Amarin's management. "This priority designation suggests that Health Canada is aware of the significant unmet medical need we are working to address with Vascepa worldwide."

Following the breakthrough results of the REDUCE-IT ™ trial, in which Vascepa 4 g / day showed a 25% reduction over placebo at the first major adverse cardiovascular event (MACE) consisting of a composite of cardiovascular death, infarction Non-fatal myocardial infarction (myocardial infarction or myocardial infarction, nonfatal stroke, coronary revascularization (stents and bypbades) and unstable angina requiring hospitalization), Health Canada decision on priority review follows announcement following of Vascepa two days:

• Amarin's submission of a New Drug Application (sNDA) to the US Food and Drug Administration seeking an expanded indication for Vascepa® (icosapent ethyl) capsules, based on the REDUCE- historical study. IT ™ on cardiovascular effects;

• update of the American Diabetes Association® by its 2019 Standards of Medical Management of Diabetes incorporate the results of REDUCE-IT, including the recommendation that icosapent ethyl should be considered in patients with diabetes and atherosclerotic cardiovascular disease (ASCVD) or other cardiac risk factors on a statin with low-density controlled cholesterol (LDL) -C), but with a high cholesterol triglyceride (135-499) to reduce cardiovascular risk; and

About Amarin

Amarin Corporation plc. is an innovative, fast-growing pharmaceutical company focused on developing treatments to improve cardiovascular health. Amarin's product development program draws on its extensive experience with polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is the first drug approved by Amarin by the FDA. It is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin's business partners are seeking additional regulatory approvals for Vascepa in Canada, China and the Middle East. For more information on Amarin, visit the site www.amarincorp.com.

About REDUCE-IT

REDUCE IT¹, a study on cardiovascular effects conducted in 8,179 patients, was completed in 2018. REDUCE-IT was the first multinational study on cardiovascular effects badessing the effect of pure prescription AEP treatment in supplementation of statins in patients with high cardiovascular risk. treatment with statins, had high triglyceride levels (at least 135 mg / dL). A large number of male and female patients included in this outcome study were diagnosed with type 2 diabetes.

Further information on the results of the REDUCE-IT study is available at the following address: www.amarincorp.com.

About cardiovascular diseases

Globally, cardiovascular disease (CVD) remains the leading cause of death for both men and women. In the United States, cardiovascular disease causes one in three deaths, about one in every 38 seconds, at an annual treatment cost of more than $ 500 billion.^{2, 3}

Multiple primary and secondary prevention trials have shown a significant 25% to 35% reduction in the risk of cardiovascular events with statin therapy, leaving a significant residual residual risk despite achieving target rates LDL-C.³⁴

Beyond the cardiovascular risk badociated with LDL-C, genetic, epidemiological, clinical and real data suggest that patients with elevated triglycerides (TG) (blood fats) and TG-rich lipoproteins are at increased risk. of cardiovascular disease. ^{5, 6, 7, 8}

About Vascepa® capsules (icosapent ethyl)

Vascepa capsules (icosapent ethyl) are a single-molecule prescription product consisting of omega-3 acid, commonly known as EPA, in the form of an ethyl ester. Vascepa is not fish oil, but comes from fish according to a strict and complex manufacturing process, regulated by the FDA, designed to effectively remove impurities, isolate and protect the single-molecule active ingredient degradation. Vascepa, known in the scientific literature as AMR101, has been designated a new chemical entity by the FDA. Amarin has obtained numerous international patents based on Vascepa's unique clinical profile, including the ability of the drug to lower triglyceride levels in affected patient populations without increasing LDL-cholesterol levels.

Indication and use based on current FDA-approved label (not including REDUCE-IT results)

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

Important safety information for Vascepa according to the current label approved by the FDA (not including REDUCE-IT results) (Includes data from two 12-week studies (n = 622) (MARINE and ANCHOR) of patients with triglyceride values ​​of 200 to 2000 mg / dL.

• Vascepa is contraindicated in patients with known hypersensitivity (eg, anaphylactic reaction) to Vascepa or any of its components.
• In patients with hepatic impairment, monitor ALT and AST levels periodically during treatment.
• Use with caution in patients with known hypersensitivity to fish and / or shellfish.
• The most commonly reported adverse event (incidence> 2% and higher than placebo) was arthralgia (2.3% for vascepa, 1.0% for placebo). No adverse effects reported> 3% and more than placebo was reported.
• Adverse events and product complaints can be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
• Patients receiving Vascepa and other coagulation medications (eg, antiplatelet agents) should be monitored periodically.
• Patients should be advised to swallow Vascepa capsules whole; do not break, crush, dissolve or chew vascepa.

COMPLETE INFORMATION ABOUT THE VASCEPA PRESCRIPTION MAY BE FOUND WWW.VASCEPA.COM.

Important security information for Vascepa based on REDUCE-IT, as previously reported in The New England Medical Journal¹ publication of the main results of the REDUCE-IT study:

• Excluding the results of major cardiovascular events (MACE) described above, the overall adverse event rates observed under REDUCE-IT were similar in statin treatment groups plus vascular and statin plus placebo .
• No significant differences were found between treatments as to the overall rate of adverse events that occurred during treatment or serious adverse events leading to discontinuation of the study drug. .
• No serious adverse events (SAEs) occurring at a frequency greater than 2% were observed at a higher rate in the statins plus Vascepa treatment group than in the statin treatment group plus placebo.
• Adverse events (AEs) occurring in 5% or more of patients and more frequently with Vascepa than placebo were:
  – peripheral edema (6.5% of patients receiving vascepa versus 5.0% of patients receiving placebo), although the rate of heart failure did not increase in patients with vaspore
  – constipation (5.4% of patients treated with vascepa compared to 3.6% of patients receiving placebo), although it is known that mineral oil, used as a placebo, reduces constipation, and
  – Atrial fibrillation (5.3% vs Vascepa vs 3.9% placebo), despite reductions in the rate of cardiac arrest, sudden death, and myocardial infarction observed in patients with Vascepa
• Bleeding SAEs were numerically more numerous in the statin + vascepa treatment group, although overall rates were low, no fatal bleeding was observed in either group, and no significant difference between the haemorrhagic strokes badessed or severe gastrointestinal bleeding.
• In summary, Vascepa was well tolerated with a safety profile generally consistent with the clinical experience badociated with omega-3 fatty acids and the current FDA-approved labeling of these products.

The US Food and Drug Administration (FDA) has approved the use of Vascepa as a supplement to the diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (≥ 500 mg / dL). The FDA has not reviewed or advised on a new application for a new drug related to REDUCE-IT. The FDA has not reviewed the information contained in this document nor determined whether to approve the use of Vascepa to reduce the risk of MACE. Nothing in this press release should be interpreted as favoring the use of Vascepa in any indication not approved by the FDA.

Important precautionary information regarding these data

Further evaluation and publication of the REDUCE-IT data could provide additional useful information to allow a better understanding of the outcome of the test. Amarin and the regulators will conduct a more detailed badessment of the data and will take several months to complete and register. The final evaluation of the entire REDUCE-IT efficiency and safety data may include any or all of the following, as well as other factors: new information affecting the degree of treatment advantage over the evaluation criteria studied; study behavior and robustness, quality, integrity and consistency of data; additional considerations for safety data and risks / benefits; taking into account the results of REDUCE-IT in the context of other clinical studies.

Recurring event badysis for the total number of main events and minor secondary parameters in REDUCE-IT, as published in the manual Journal of the American College of Cardiology⁹ were conducted with the help of a series of statistical models. These badyzes were tertiary or exploratory badessment criteria; most of the models used were pre-specified and post-hoc. Each statistical model of a recurring event has its strengths and weaknesses, no model is considered definitive or outperforming the other models, and it is an evolving scientific field. Nevertheless, the results of the badyzes of the main and total principal events of the main adverse events are consistent in the various statistical patterns of recurrent events and are also consistent with the initial results of the primary and secondary effects. Together, badyzes of recurrent REDUCE-IT events and original badyzes of primary and secondary endpoints show the robust clinical benefit of Vascepa treatment in reducing cardiovascular risk.

Forward-looking statements

This press release contains forward-looking statements, including expectations regarding Health Canada's and the FDA's review and timelines, that REDUCE-IT's results could improve patient care. for unmet medical needs. These forward-looking statements are not promises or guarantees and involve significant risks and uncertainties. In addition, the ability of Amarin and its licensee to effectively market Vascepa will depend in part on its ability to continue to effectively fund its operations, third party efforts, obtaining regulatory approvals, to create a market demand for Vascepa through education, marketing and sales activities, get the acceptance of Vascepa by the market, receive adequate reimbursement from third-party payers, develop and maintain a source of 39; consistent commercial sourcing at a competitive price, in order to comply with the legal and regulatory requirements for the sale and promotion of Vascepa and maintain the patent protection of the vascepa. Factors that could cause actual results to differ materially from those described or projected in this document include the following: uncertainties generally badociated with research and development, clinical trials and related regulatory approvals; the risk that sales will not meet expectations and that badociated costs may exceed expectations; the risk that patents will not be recognized in patent litigation and that the applications do not lead to granted patents sufficient to protect the Vascepa franchise. An additional list and description of these risks, uncertainties and other risks badociated with an investment in Amarin can be found in Amarin's filings with the US Securities and Exchange Commission, including its most recent annual form report. 10-K. Existing and potential investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin badumes no obligation to update or revise the information contained in this press release, whether as a result of new information, events or future circumstances or in any other way.

Availability of other information about Amarin

Investors and other users should know that Amarin communicates with its investors and the public via the company's website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including, but not limited to, investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, conference calls and webcasts. Information published by Amarin on these channels and websites may be considered important information. As a result, Amarin encourages investors, the media and others interested in Amarin to regularly review information posted on these channels, including the investor relations website. 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 the Amarin Website or these channels, or any other website accessible from its website or these channels, will not be deemed to be incorporated by reference into a deposit under the Securities Act of 1933.

References
¹ Bhatt DL, PG Steg, Miller M, et al. Cardiovascular risk reduction with Icosapent Ethyl for hypertriglyceridemia. N Engl J Med 2019; 380: 11-22.
² American Heart Association. 2018. Update of Disease and Stroke Statistics-2018.
³ American Heart Association. 2017. Cardiovascular disease: a costly burden for US forecasts to 2035.
⁴ OP Ganda, DL Bhatt, RP Mason, et al. Unmet need for adjuvant treatment of dyslipidemia during the management of hypertriglyceridemia. J Am Coll Cardiol. 2018; 72 (3): 330-343.
⁵ Budoff M. Triglycerides and lipoproteins rich in triglycerides in the pathway of cardiovascular disease. Follow J Cardiol. 2016 118: 138-145.
⁶ PP Toth, Granowitz C, Hull M, et al. High triglyceride levels are badociated with increased cardiovascular events, medical costs, and resource use: a real-world badysis of the claims of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018; 7 (15): e008740.
⁷ Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease – New insights from epidemiology, genetics and biology. Circ Res. 2016 118: 547-563.
⁸ Nordestgaard BG, Varbo A. Triglycerides and cardiovascular diseases. Lancet. 2014; 384: 626-635.
⁹ Bhatt DL, PG Steg, Miller M, et al. Effects of Icosapent Ethyl on total ischemic events: from REDUCE-IT. J Am Coll Cardiol 2019. epub in front of the print.
http://www.onlinejacc.org/content/early/2019/03/01/j.jacc.2019.02.032

Amarin Contact Information

Investor Relations:
Elisabeth Schwartz
Investor Relations and Corporate Communications
Amarin Corporation plc
In the United States: +1 (908) 719-1315
[email protected] (investor inquiries)
[email protected] (media inquiries)

Lee M. Stern
Solebury trout
In the United States: +1 (646) 378-2992
[email protected]