vascepa cost in canada

Am J Cardiol. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Prices do not include dispensing fees. … Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35% – but that still leaves 65-75% of risk remaining.5 People with high triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.6,7,8, About VASCEPA® (icosapent ethyl) Capsules. Since launch, VASCEPA has been prescribed over eight million times and is covered by most major medical insurance plans. 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]. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. Availability of Other Information About Amarin. We are confident that HLS will work to educate healthcare professionals across Canada on the life-saving and risk-reducing effects of VASCEPA. Amarin Contact InformationInvestor Inquiries:Elisabeth SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315investor.relations@amarincorp.com, Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992lstern@soleburytrout.com, Media Inquiries:Gwen FisherCorporate CommunicationsAmarin Corporation plcIn U.S.: +1 (908) 325-0735pr@amarincorp.com. 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. 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. FULL VASCEPA UNITED STATES PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. In addition, Amarin's ability, directly or through licensees, to effectively commercialize VASCEPA will depend in part on its ability to continue to effectively finance its business, efforts of third parties, its ability to gain regulatory approvals, create market demand for VASCEPA through education, marketing and sales activities, to achieve 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 exclusivity through grant of regulatory exclusivity and through patent protection for VASCEPA in various markets. “We estimate that Vascepa could be a ~$300-million drug in Canada at peak value, implying an incremental $25 per share to a $10 per share base business of primarily Clozaril or … Once coverage has been approved by payers, … To obtain prescription … 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. New England Journal of Medicine. Scientific and Medical Recognition Outside CanadaVascepa and the REDUCE-IT study data have received widespread support within the North American and European medical communities. Available from: Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, et al. VASCEPA® (icosapent ethyl) is a prescription medication approved, along with certain medicines (statins), to reduce the risk of heart attack, stroke and certain types of heart issues. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. The main differences between Vascepa and fish oil is that Vascepa … Vascepa is already approved as a preventive for people with extremely high triglyceride levels—500 … diabetes mellitus and two or more additional risk factors for cardiovascular disease. 2016;118:547-563. Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease. The objective of the analysis was to estimate the difference in benefit and cost of Vascepa compared to placebo, as adjunct therapy to statins, for both the primary and secondary prevention of cardiovascular events in a population of patients described in the REDUCE-IT trial. Recently, an analysis of the REDUCE-IT study data, aimed at determining the extent to which icosapent ethyl reduces the risk of subsequent cardiovascular events, was also carried out5. LCA- Low cost … Furthermore, under the terms of this agreement, Amarin will receive $2.5 million as a result of today's approval by Health Canada and is eligible to receive more than $50.0 million in additional milestone payments, most of which are sales-based milestones. Cardiovascular Disease is an Urgent Public Health Issue"There is no doubt that cardiovascular disease is an urgent and growing public health issue, with more than half of Canadian adults2 impacted by the disease in ways that can be tragic and costly," said Greg Gubitz, Chief Executive Officer of HLS. The wholesale price of VASCEPA is $344.22 for 120 1g capsules and $402.73 for 240 0.5g capsules. The information that Amarin posts on these channels and websites could be deemed to be material information. Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. Amarin’s lead product, VASCEPA® (icosapent ethyl), is available by prescription in the United States, Lebanon and the United Arab Emirates, and is expected to be available in Canada through an anticipated February 2020 commercial launch. Such statements are based on the current expectations and views of future events of HLS's management. 2019;73(22):2791–802. Available from: Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, et al. 2016 [cited. The price of a 1-gram capsule of Vascepa will be $2.45. J Am Coll Cardiol. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. Amarin is responsible for supplying VASCEPA for sale in Canada on a cost-plus basis. Heart Disease and Stroke Statistics – 2019 Update: A Report from the American Heart Association. 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. … Patients with such allergies should discontinue VASCEPA if any reactions occur. Amarin Pharma, Inc. 440 Route 22 Bridgewater, NJ 08807 Tel: 1-855-VASCEPA (827-2372) 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. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. The approval was achieved through Amarin’s commercial licensee for VASCEPA in Canada, HLS Therapeutics, Inc. (“HLS”). 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. 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. 2005Jul;352(14):1425–35. HLS is managed by an experienced and capable team of pharmaceutical industry professionals and we look forward to witnessing their progress,” stated John F. Thero, president and chief executive officer of Amarin. 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. Amarin is responsible for supplying VASCEPA for sale in Canada on a cost-plus basis. 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 initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. 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. Accordingly, readers should not place undue reliance on any forward-looking statements or information. The monthly treatment cost, based on a 2-gram twice daily administration, will be $294. Commercially insured patients can save with the VASCEPA Savings Card. The monthly treatment cost, based on a 2-gram twice daily administration, will be $294. 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. We look forward to bringing this product to Canadians in the coming weeks.". In November 2019, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) reviewed and voted unanimously (16-0) to recommend approval of Amarin's submission for an indication and label expansion for Vascepa (icosapent ethyl) capsules in the US to reduce the risk of cardiovascular events in high-risk patients based on results from the REDUCE-IT trial. Please see … A bottle of 45 pills costs about $30, and users would take four pills a day. These prices: Do not account for prescription insurance and co-pays; Apply only to those prescriptions purchased and mailed from Costco.com; Occasionally prices … 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. Prescription prices may vary from pharmacy to pharmacy and are subject to change. Health Canada's regulatory approval was based on data from the 8,179 patient REDUCE-IT® outcomes trial, a landmark cardiovascular outcome study that has been referred to as the most significant of the last 25 years in the field of preventative cardiology3. The top 10 causes of death [Internet]. 2017. 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. 2019 [cited 2020Jan27]. 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. "Cardiovascular disease costs Canadians more than $21.2 billion each year2, and stroke alone costs the Canadian economy $3.6 billion a year in physician services, hospital costs, lost wages and decreased productivity2. 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. 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. Canadian Agency for Drugs and Technologies in Health (CADTH). 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. Available from: Larosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart J-C, et al. The approval of VASCEPA by Health Canada positions this important drug to address a large unmet medical need. Pursuant to an agreement announced in 2017, HLS has exclusive commercial rights to VASCEPA in the Canadian market. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The lowest GoodRx price for the most common version of generic Vascepa is around $94.78, 73% off the average retail price of … This could save you up to $150 per month, or $450 for a 90-day prescription. QALY is a measure of disease burden, including both the quality and the quantity of life lived. 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. Provincial drug plans are also being actively engaged in compliance with the relevant public processes of the various provinces. FORWARD LOOKING INFORMATIONThis release includes forward-looking statements regarding HLS and its business. 2016 [cited, CADTH Canadian Drug Expert Committee Final Recommendation- Alirocumab [Internet]. Fornell D, editor. The results from this analysis suggest that as patients continued treatment after the first event, icosapent ethyl not only reduces the residual risk of a first cardiovascular event by 25%, but also prevents the occurrence of subsequent events by 32%, 31% and 48% for the second, third and fourth or more events, respectively, or 159 events for every 1,000 patients5. In addition to milestone and supply payments, the agreement for commercialization in Canada provides … HLS currently expects Canadian sales of VASCEPA to reach between CAD $150 and $250 million per year. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. 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 … 2016;118:138-145.7 Toth PP, Granowitz C, Hull M, et al. Journal of the American College of Cardiology. World Health Organization. Once coverage has been approved by payers, the cost to covered patients is expected to be lower based on individual plan benefits. Vascepa (icosapent ethyl) is used to reduce cardiovascular risk and treat high triglyceride levels.It is more popular than other comparable drugs. Vascepa (icosapent) is a member of the miscellaneous antihyperlipidemic agents drug class and is commonly used for Cardiovascular Risk Reduction and Hypertriglyceridemia. The prices listed are the most recent cash prices. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with acceptance of clinical trial results and related regulatory approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations; the risk that exclusivity may not be obtained by governing authorities and that patents may not be upheld in patent litigation and applications may not result in issued patents sufficient to protect the VASCEPA franchise. At launch, Vascepa will be supported by the Company's national Cardiovascular salesforce, initially sized at 22 representatives, in addition to eight other field-based roles. A Cision company. In the United States, two separate health economic studies presented in recent months conclude that VASCEPA is cost … is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Copyright © 2021 CNW Group Ltd. All Rights Reserved. Find patient medical information for Vascepa oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death, https://www.heartandstroke.ca/-/media/pdf-files/canada/2019-report/heartandstrokereport2019.ashx, https://www.dicardiology.com/article/fda-expands-vascepa-reduce-cardiovascular-events-elevated-triglyceride-patients, https://www.nejm.org/doi/full/10.1056/NEJMoa1812792, https://www.sciencedirect.com/science/article/pii/S0735109719337969, https://www.nejm.org/doi/full/10.1056/NEJMoa050461, https://www.nejm.org/doi/full/10.1056/NEJMoa1615664, https://www.cadth.ca/sites/default/files/cdr/complete/SR0441_complete_Rapatha-Feb-23_16_e.pdf, https://www.cadth.ca/sites/default/files/cdr/complete/SR0469_complete_Praluent_Jul-20-16.pdf, First occurrence of Major Adverse Cardiovascular Events (MACE) reduced by 25%, Fatal or Nonfatal Heart Attacks Reduced by 31%, Urgent or Emergent Coronary Revascularization Reduced by 35%, Hospitalization for Unstable Angina Reduced by 32%. 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%). Amarin Corporation plc. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. 2018 [cited 2020Jan 27]. 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. To support this pricing from a pharmacoeconomic perspective, HLS commissioned and submitted to various Health Technology Assessment ("HTA") organizations, an unpublished cost-utility analysis. Published January 31, 2019.3 American Heart Association / American Stroke Association. Canadians deserve access to the latest innovations to reduce the risk of cardiovascular death and the consequences of other major cardiovascular events. Mr. Gubitz added: "Our goal is to make Vascepa accessible to all Canadian patients who may stand to benefit from it, and we believe we have priced it at an accordingly cost-effective and affordable level. 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. 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. HLS in-licensed the exclusive rights to Vascepa for the Canadian market from Amarin Corporation (NASDAQ:AMRN). VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates. Canadian Agency for Drugs and Technologies in Health (CADTH). The price of a 1-gram capsule of Vascepa will be $2.45. Diagnostic and Interventional Cardiology (DAIC). N Engl J Med 2019;380:11-22.2 American Heart Association. 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 … Amarin Provides Update on VASCEPA® (Icosapent Ethyl) Regulatory Review Processes in Mainland China and Hong Kong GlobeNewswire Inc. - 2/9/2021 7:00:00 AM: Current Report … 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. VASCEPA … Available from: Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, et al. Pricing of VASCEPA in Canada will be jointly established by the parties. In addition, shipping costs … Important Safety Information (United States). In the United States, two separate health economic studies presented in recent months conclude that VASCEPA is cost-effective. 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. 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. 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. 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. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. 2017Apr;376(18):1713–22. 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.

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