Such increases are consistent with third-party analysis, which found VASCEPA to be cost effective, and with medical guidelines or recommendations from six leading U.S. … 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. 2016 [cited, CADTH Canadian Drug Expert Committee Final Recommendation- Alirocumab [Internet]. 2016;118:547-563. As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and. 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. For more information visit: www.hlstherapeutics.com. In clinical study of VASCEPA over approximately five years of patient follow-up, approximately 28 percent of patients treated with statins and other contemporary therapy but not treated with VASCEPA experienced a major adverse cardiovascular event (MACE), defined as the first occurrence of either myocardial infarction (heart attack), stroke, coronary revascularization, unstable angina requiring hospitalization or cardiovascular death.1 As evidenced by this MACE occurrence, there is a group of patients who, despite controlling their cholesterol on statin therapy, continue to have persistent high cardiovascular risk. 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. Patients with such allergies should discontinue VASCEPA if any reactions occur. Once coverage has been approved by payers, … VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. We look forward to bringing this product to Canadians in the coming weeks.". The wholesale price of VASCEPA is $344.22 for 120 1g capsules and $402.73 for 240 0.5g capsules. Please see … New England Journal of Medicine. Available from: 2019 Report on Heart, Stroke and Vascular Cognitive Impairment (Pg 14) [Internet]. VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. For more information visit: www.hlstherapeutics.com. The top 10 causes of death [Internet]. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%). Under the previously announced terms of the Amarin-HLS’s agreement, in 2017 HLS paid Amarin $5.0 million to in-license the exclusive Canadian rights to VASCEPA and in 2018 paid an additional $2.5 million following reporting of successful clinical outcomes study (REDUCE-IT) results for VASCEPA. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. Prices do not include dispensing fees. On December 31, 2019, Vascepa was approved by Health Canada and is indicated to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides who are at high risk of cardiovascular events due to established cardiovascular disease or diabetes and at least one other cardiovascular risk factor. In addition, shipping costs … A bottle of 45 pills costs about $30, and users would take four pills a day. This could save you up to $150 per month, or $450 for a 90-day prescription. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated April 1, 2019, which has been filed on SEDAR and can be accessed at www.sedar.com. In addition to milestone and supply payments, the agreement for commercialization in Canada provides … FDA Expands Vascepa to Reduce Cardiovascular Events in Elevated Triglyceride Patients [Internet]. SAFETYIn REDUCE-IT, adverse events occurring with Vascepa (icosapent ethyl) use at greater than 5% and greater than placebo were: peripheral edema (6.5% Vascepa versus 5.0%), although there was no increase in the rate of heart failure in Vascepa patients; constipation (5.4% Vascepa versus 3.6%); and atrial fibrillation (5.3% Vascepa versus 3.9%). Diagnostic and Interventional Cardiology (DAIC). Amarin’s commercial partners are pursuing additional regulatory approvals for Vascepa in Canada… On December 13, 2019, the United States Food and Drug Administration (FDA) expanded the indicated use of VASCEPA to include use “as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.”. Vascepa was granted a Priority Review as it met Health Canada's criteria of intending to address a serious, life-threatening or debilitating disease or condition for which no drug was marketed in Canada, and for which there is substantial evidence of clinical effectiveness of the treatment. The cost for a monthly or yearly treatment of Vascepa (icosapent ethyl) depends on your prescription requirements which includes the dosage in g/mg/ml/etc and medicine type (Capsules). New England Journal of Medicine. DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 02, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) is pleased to announce that Health Canada has approved the use of VASCEPA® (icosapent ethyl) to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. [1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality. Published January 31, 2019.3 American Heart Association / American Stroke Association. The main differences between Vascepa and fish oil is that Vascepa … Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union, the Middle East and North Africa, and is evaluating other regions for potential regulatory filings. 2017. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. Fornell D, editor. HLS Therapeutics (OTCPK:HLTRF) announces that Vascepa (icosapent ethyl) will be available in Canada on or about February 18.The launch will be supported by a … The approval was achieved through Amarin’s commercial licensee for VASCEPA in Canada, HLS Therapeutics, Inc. (“HLS”). HLS in-licensed the exclusive rights to Vascepa for the Canadian market from Amarin Corporation (NASDAQ:AMRN). Based on this industry standard measure for comparing costs of therapies, Vascepa is significantly less than that of several newer therapies, including other cardiovascular drugs8,9. This press release contains forward-looking statements, including expectations regarding regulatory submissions and approvals and commercialization of VASCEPA in Canada and other markets, as well as timing related thereto, potential milestone and other payments to be paid to Amarin, commercial market expectations including pricing and sales potential, the applicability and reliability of REDUCE-IT results, and cost effectiveness data expectations regarding commercial expansion and the use of VASCEPA. Vascepa was developed and tested over the course of a decade and at a cost of more than $500.0 million in order to bring a new preventative care solution that may help the many family members, friends and neighbors who may be at risk for a cardiac event. We are confident that HLS will work to educate healthcare professionals across Canada on the life-saving and risk-reducing effects of VASCEPA. Amarin’s lead product, VASCEPA ® (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. 1 Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM. As a result of its approval, Vascepa is now the first and only drug in Canada indicated to reduce persistent residual cardiovascular risk in patients stabilized on a statin, with elevated triglycerides and other risk factors for cardiovascular disease. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin. Under the previously announced terms of the Amarin-HLS’s agreement, in 2017 HLS paid Amarin $5.0 million to in-license the exclusive Canadian rights to VASCEPA and in … More information regarding clinical studies of VASCEPA can be found at www.amarincorp.com. The eligible patents will be added to Health Canada's Patent Register following receipt of NOC and in accordance with Health Canada's process. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Vascepa (icosapent ethyl) is used to reduce cardiovascular risk and treat high triglyceride levels.It is more popular than other comparable drugs. J Am Coll Cardiol. Such analyses suggested that the price of VASCEPA in the United States could be considerably higher and still remain cost-effective. © 2021 GlobeNewswire, Inc. All Rights Reserved. 1 This comprehensive analysis evaluated the cost … In the US and in Europe, a growing number of medical societies including the American Heart Association (AHA), the American Diabetes Association (ADA), the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) have already updated their Clinical Practice Guidelines for the Management of Dyslipidaemias and are recognizing the importance of the REDUCE-IT study by recommending the usage of Vascepa (icosapent ethyl) in appropriate patients. Investors and others should note that Amarin communicates with its investors and the public using the company 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, public conference calls and webcasts. Available from: Larosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart J-C, et al. 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. 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. Canadian Agency for Drugs and Technologies in Health (CADTH). The eligible patents will be added to Health Canada’s Patent Register following receipt of NOC and in accordance with Health Canada’s process. Vascepa (icosapent ethyl) is a prescription omega-3 fatty acid that is similar to fish oil but not exactly the same. 2017Apr;376(18):1713–22. Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. HLS paid Amarin $5.0 million to in-license the exclusive Canadian rights to Vascepa in 2017 and a further $2.5 million on the successful REDUCE-IT trial results in 2018. Once coverage has been approved by payers, the cost to covered patients is expected to be lower based on individual plan benefits. … 2018;7(15):e008740.8 Nordestgaard BG. Vascepa (icosapent) is a member of the miscellaneous antihyperlipidemic agents drug class and is commonly used for Cardiovascular Risk Reduction and Hypertriglyceridemia. HLS plans to use the results of the REDUCE-IT study, pharmacoeconomic analysis and other medical information and data, as the Company continues in its discussions with HTA organizations and payers to support Vascepa coverage. Indications and Limitation of Use (United States). This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. Vascepa Prices The cost for Vascepa oral capsule 0.5 g is around $430 for a supply of 240 capsules, depending on the … FULL VASCEPA UNITED STATES PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. For further information: HLS CONTACT INFORMATION: Dave Mason, Investor Relations, HLS Therapeutics Inc., (416) 247-9652, [email protected]; Gilbert Godin, President and Chief Operating Officer, HLS Therapeutics Inc., (484) 232-3400 ext101, [email protected]. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the U.S. prescribing information for VASCEPA, as set forth below: Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT. Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE), Cardiovascular death, myocardial infarction, stroke (3-point MACE), Emergent or urgent coronary revascularization. “We congratulate HLS on securing this important approval of VASCEPA. VASCEPA is not yet … These findings reflect the affordable pricing of VASCEPA in the United States and the relatively high costs of MACE, such as heart attacks and stroke, which VASCEPA helps avoid. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. The price of a 1-gram capsule of Vascepa will be $2.45. Amarin Contact InformationInvestor Inquiries:Elisabeth SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: +1 (908) [email protected], Lee M. SternSolebury TroutIn U.S.: +1 (646) [email protected], Media Inquiries:Gwen FisherCorporate CommunicationsAmarin Corporation plcIn U.S.: +1 (908) [email protected]. This health-economic modeling was based on a 20-year time horizon and carried out from a societal perspective in which the cost of drug acquisition, is evaluated against health care costs associated with cardiovascular events (fatal and non-fatal MI, fatal and non-fatal stroke, coronary revascularization, unstable angina), as well as medical visits, laboratory tests, management of adverse events and loss of productivity if the drug was not used. About HLS Therapeutics Inc.Formed in 2015, HLS is a specialty pharmaceutical company focused on the acquisition and commercialization of late stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. In addition to milestone and supply payments, the agreement for commercialization in Canada provides for payment to Amarin of double-digit royalties on VASCEPA net sales in Canada. Available from: CADTH Canadian Drug Expert Committee Final Recommendation- Evolocumab [Internet]. These prices: Do not account for prescription insurance and co-pays; Apply only to those prescriptions purchased and mailed from Costco.com; Occasionally prices … In the health-economics study presented by HLS to HTA organizations, at less than $10 per day, Vascepa has been shown to be cost-effective with an estimated cost-per quality-adjusted life-year (QALY) of $42,797. LCA- Low cost … VASCEPA … ABOUT VASCEPA (ICOSAPENT ETHYL) CAPSULES VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. As reflected in the Health Canada approved label, VASCEPA demonstrated a 25% relative risk reduction in the first occurrence of MACE in these high-risk patients. Vascepa is the subject of numerous Canadian issued patents and pending patents with expiration dates which could extend to 2039. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities and expectations regarding financial performance.

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