New Drug Submission Filed for Vascepa® with Health Canada

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<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "BEDMINSTER, NJ, and DUBLIN, Ireland, April 29th 2019 (GLOBE NEWSWIRE) – Amarin Corporation plc (AMRN), a pharmaceutical company focused on improving cardiovascular health, announced today that its Canadian licensee, HLS Therapeutics Inc. (HLS.TO) has filed a New Drug Submission ("NDS") with Health Canada for Vascepa® (icosapent ethyl) capsules. The NDS is seeking an indication of promotion of Vascepa in Canada to reduce the risk of major adverse cardiovascular events ("MACE") in patients treated with statins with elevated triglycerides and other risk factors . This is Vascepa's first submission to Health Canada for any indication and, if approved, Vascepa will be the first approved drug in Canada for this important indication.
"data-reactid =" 11 "> BEDMINSTER, NJ, and DUBLIN, Ireland, April 29, 2019 (GLOBE NEWSWIRE) – Amarin Corporation plc (AMRN), a pharmaceutical company specializing in the improvement of cardiovascular health, announced today His Canada licensee, HLS Therapeutics Inc. (HLS.TO), has filed with Health Canada a new drug submission ("NDS") for Vascepa® (icosapent-ethyl) capsules, which is intended to promote development of Vascepa in Canada to reduce the risk of major adverse cardiovascular events ("ADLI") in statin patients with elevated triglyceride levels and other risk factors: this is Vascepa's first submission to Health Canada for any indication and, if approved, Vascepa will be the first drug approved in Canada for this important indication.

As previously announced, Health Canada has granted Vascepa priority review status. The Priority Review could expedite the launch of Vascepa in the Canadian market for up to four and a half months if the product is ultimately approved by Health Canada. 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.

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 hope that Vascepa will soon be approved to treat at-risk patients in Canada and we congratulate HLS Therapeutics for moving quickly on this issue," commented John F. Thero, President and CEO of Amarin. "Cardiovascular disease is a major health problem in Canada and around the world. Vascepa offers physicians a new treatment option to reduce cardiovascular risk beyond the management of cholesterol in at-risk patients. "

About Amarin

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Amarin Corporation plc is an innovative fast-growing company. Amarin's product development program builds on its extensive experience in the field of polyunsaturated fatty acids and lipid science.Vascepa (icosapent ethyl) is the first FDA approved drug from Amarin and is available by prescription in the United States, Lebanon Amarin's business partners are seeking additional regulatory approvals for Vascepa in Canada, China and the Middle East For more information on Amarin, please visit www.amarincorp.com. "data-reactid =" 16 "> Amarin Corporation plc is a fast-growing, innovative pharmaceutical company dedicated to developing drugs to improve cardiovascular health. extensive experience with polyunsaturated fatty acids and lipid science Vascepa (icosapent Ethyl is the first FDA-approved drug for Amarin and is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin are seeking other regulatory approvals for Vascepa in Canada, China and the Middle East., Visit www.amarincorp.com.

About REDUCE-IT

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "REDUCE-IT¹, a cardiovascular outcome study in 8,179 patients, was completed in 2018. REDUCE-IT was the first multinational study of cardiovascular effects evaluating the effect of pure EPA therapy in combination with statins in patients with patients with high cardiovascular risk. statin therapy, had elevated triglyceride levels (at least 135 mg / dL). A large number of male and female patients included in this study were diagnosed with type 2 diabetes. & Nbsp; "data-reactid =" 18 "> REDUCE-IT¹, a cardiovascular outcome study in 8,179 patients, was completed in 2018. REDUCE-IT was the first multinational study of cardiovascular effects evaluating the effect of pure EPA therapy in combination with statins in patients with patients with high cardiovascular risk. statin therapy, had elevated 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.

<p class = "canvas-atom-canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "For more information on the results of the REDUCE-IT study, you can be found at www.amarincorp.com"data-reactid =" 19 "> For more information on the results of the REDUCE-IT study, visit the website www.amarincorp.com.

About cardiovascular disease

<p class = "web-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Worldwide, cardiovascular disease (CVD) remains # In the United States, cardiovascular disease results in one in every three deaths, about one in every 38 seconds, at an annual treatment cost of over $ 500 billion.^{2, 3}"data-reactid =" 21 "> Worldwide, cardiovascular disease (CVD) remains the leading cause of death for both men and women, with cardiovascular disease leading to one in three deaths in the United States – one death every 38 seconds – with an annual processing cost – more than $ 500 billion.^{2, 3}

<p class = "canvas-atom-canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Multiple & nbsp;primary and secondary preventionClinical trials have shown a significant 25% to 35% reduction in the risk of & nbsp;cardiovascular events& nbsp; with & nbsp;statin& nbsp; treatment, leaving a significant residual residual risk despite the achievement of target LDL-C levels.⁴"data-reactid =" 22 "> Multiple primary and secondary prevention trials have shown a significant reduction in the risk of cardiovascular events with statin therapy, from 25% to 35%, leaving a significant residual risk remaining in despite the achievement of the target LDL-C level.⁴

<p class = "web-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Beyond the cardiovascular risk associated with LDL-C, Genetic, epidemiological, clinical and real data suggest that patients with elevated triglycerides (TG) (blood lipids) and TG-rich lipoproteins are at increased risk for cardiovascular disease.^5-8"data-reactid =" 23 "> Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiological, clinical and real data suggest that patients with elevated triglycerides (TG) (blood fats) and of TG-rich lipoproteins, are at increased risk of cardiovascular disease.^5-8

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 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 and 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 received numerous international patents based on Vascepa's unique clinical profile, including the ability of the drug to lower triglyceride levels in relevant patient populations without increasing LDL-cholesterol levels.

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Indication and use based on current FDA-approved label (not including REDUCE-IT results)"data-reactid =" 30 ">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.

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Important safety information for Vascepa according to the current label approved by the FDA (not including the results of REDUCE-IT) (Includes data from two 12-week studies (n = 622) (MARINE and ANCHOR) of patients with triglyceride values between 200 and 2000 mg / dL. "data-reactid =" 34 ">Important safety information for Vascepa according to the current label approved by the FDA (not including the results of REDUCE-IT) (Includes data from two 12-week studies (n = 622) (MARINE and ANCHOR) of patients with triglyceride values between 200 and 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 has been 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 in their entirety; do not break, crush, dissolve or chew vascepa.

Mb (0) – sm Mt (0.8em) – sm "type =" text "content =" FULL VASCEPA PRESCRIPTION INFORMATION MAY BE FOUND WWW.VASCEPA.COM. "data-reactid =" 43 "> COMPLETE INFORMATION ON THE VASCEPA PRESCRIPTION MAY BE FOUND WWW.VASCEPA.COM.

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "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: "data-reactid =" 44 ">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 in the REDUCE-IT setting were similar in the statin plus vascular treatment groups 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 statin plus Vascepa group than in the statin plus placebo group.
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% of patients receiving placebo), although the rate of heart failure did not increase

– constipation (5.4% of patients treated with the tub, versus 3.6% of patients receiving a placebo), although mineral oil, used as placebo, is known to reduce constipation, and

– Atrial fibrillation (5.3% vs vascepa vs. 3.9% placebo), although rates of cardiac arrest, sudden death, and myocardial infarction were observed

Bleeding SAEs were numerically more numerous in the statin and vascepa treatment group, although overall rates were low, no fatal bleeding was observed in both groups and no significant difference in the estimated haemorrhagic stroke. , severe central or gastrointestinal bleeding.
In summary, Vascepa was well tolerated with a safety profile generally consistent with the clinical experience associated 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 an adjunct to diet to lower triglyceride levels in adult patients with severe hypertriglyceridemia (≥ 500 mg / dL) . The FDA has not reviewed or given its opinion 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 assessment 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.

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 Vascepa's acceptance in the market, receive adequate reimbursement from third-party payers, develop and maintain a source of 39 consistent commercial supply at a competitive price, in order to comply with the legal and regulatory requirements regarding the sale and promotion of Vascepa and maintain the patent protection for Vascepa. Factors that could cause actual results to differ materially from those described or projected in this document include the following: uncertainties generally associated with research and development, clinical trials and related regulatory approvals; the risk that sales will not meet expectations and that associated costs may exceed expectations; the risk that patents will not be sustained and that applications do not lead to the issuance of patents sufficient to protect the Vascepa franchise. An additional 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 US Securities and Exchange Commission, including its most recent annual report on Form 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 assumes 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

<p class = "canvas-atom-text-canvas Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Investors and others should note that Amarin communicates with its investors and the public using 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, shall not be considered incorporated by reference in a filing under the Securities Act of 1933 . "data-reactid =" 62 "> 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

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "^{1 & nbsp;}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 & nbsp;}American Heart Association. 2018. Disease and Stroke Statistics, updated 2018.
^{3 & nbsp;}American Heart Association. 2017. Cardiovascular disease: a costly burden for US forecasts to 2035.
⁴OP 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 & nbsp;}Budoff M. Triglycerides and lipoproteins rich in triglycerides in the pathway of cardiovascular disease. Follow J Cardiol. 2016 118: 138-145.
^{6 & nbsp;}PP Toth, Granowitz C, Hull M, et al. High triglyceride levels are associated with increased cardiovascular events, medical costs, and resource use: Real-world analysis of claims for statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018; 7 (15): e008740.
^{7 & nbsp;}Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular diseases – New knowledge in epidemiology, genetics and biology. Circ Res. 2016 118: 547-563.
^{8 & nbsp;}Nordestgaard BG, Varbo A. Triglycerides and cardiovascular diseases. Lancet. 2014; 384: 626-635. "Data-reactid =" 64 ">¹Bhatt DL, PG Steg, Miller M, et al. Cardiovascular risk reduction with Icosapent Ethyl for hypertriglyceridemia. N Engl J Med 2019; 380: 11-22.
²American Heart Association. 2018. Disease and Stroke Statistics, updated 2018.
³American Heart Association. 2017. Cardiovascular disease: a costly burden for US forecasts to 2035.
⁴OP 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.
⁵Budoff M. Triglycerides and lipoproteins rich in triglycerides in the pathway of cardiovascular disease. Follow J Cardiol. 2016 118: 138-145.
⁶PP Toth, Granowitz C, Hull M, et al. High triglyceride levels are associated with increased cardiovascular events, medical costs, and resource use: Real-world analysis of claims for statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018; 7 (15): e008740.
⁷Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular diseases – New knowledge in epidemiology, genetics and biology. Circ Res. 2016 118: 547-563.
⁸Nordestgaard BG, Varbo A. Triglycerides and cardiovascular diseases. Lancet. 2014; 384: 626-635.

Amarin Contact Information

Investor Relations:

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Elisabeth Schwartz
Investor Relations and Corporate Communications
Amarin Corporation plc
Aux & nbsp; U.S .: +1 (908) 719-1315
[email protected] (investor requests)
[email protected] (media inquiries) "data-reactid =" 67 "> 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)

<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "
Lee M. Stern
Solebury trout
Aux & nbsp; U.S .: +1 (646) 378-2992
[email protected]& nbsp; "data-reactid =" 68 ">
Lee M. Stern
Solebury trout
In the United States: +1 (646) 378-2992
[email protected]

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