HLS Therapeutics Announces High Risk of Atherosclerotic Cardiovascular Events Projected in People with Elevated Triglycerides Without Established Atherosclerotic Cardiovascular Disease

TORONTO, March 19, 2019 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focused on central nervous system and cardiovascular markets, announces that on March 16, 2019, Amarin Corporation plc (NASDAQ:AMRN), released the presentation of data and analysis which concluded that over nine million atherosclerotic cardiovascular disease (ASCVD) events are projected to occur in the United States within the next ten years in adults aged 40-79 for whom ASCVD is not established. Over three million of these events are projected to occur in persons with elevated triglyceride (TG) levels of ≥150 mg/dL, including approximately one million events in statin users. The research used proportions of risk by TG level and reflected that increased cardiovascular (CV) risk was associated with higher TG levels. This research highlights that millions of CV events will occur in people that haven't had a CV event and supports the need for expanded education about the use of TG levels as an identifier of cardiovascular risk. It also highlights that there is an urgent need to address this immense risk and examine the capacity of lifestyle modification and other therapies to attenuate ASCVD risk beyond cholesterol management in patients with elevated TG levels.

These data and analysis were presented in a poster entitled "Burden of Atherosclerotic Cardiovascular Disease Risk in Persons with Elevated Triglyceride Levels According to Statin Use" at the American College of Cardiology's (ACC) 68th Annual Scientific Session in New Orleans, LA. The research used the ACC/AHA risk calculator and NHANES data with corresponding projected population sizes to estimate a 10-year risk of cardiovascular death, nonfatal myocardial infarction (MI or heart attack), or fatal/nonfatal stroke in people without established atherosclerotic cardiovascular disease (ASCVD). The analysis did not include other major adverse cardiovascular events such as by-pass surgery, stents or hospitalization for angina.

"This presentation underscores that people with elevated triglycerides without known cardiovascular disease could be at a high risk for cardiovascular events," said Greg Gubitz, CEO of HLS Therapeutics. "This could represent close to one million Canadians for whom lowering triglyceride levels alone without reducing other cardiovascular risks may be insufficient to significantly lower cardiovascular risk. Elevated triglyceride levels may provide a means of identifying increased cardiovascular risk beyond cholesterol levels."

This poster was authored by Nathan D. Wong, Wenjun Fan, Sephy Philip, Craig Granowitz, and Peter Toth.

ABOUT AMARIN
Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. 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.  Amarin's commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East. For more information about Amarin, visit www.amarincorp.com.

ABOUT REDUCE-IT
REDUCE-IT¹, an 8,179-patient cardiovascular outcomes study, was completed in 2018. REDUCE-IT was the first multinational cardiovascular outcomes study that evaluated the effect of prescription pure EPA therapy as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, had elevated triglyceride levels (at least 135 mg/dL). A large portion of the male and female patients enrolled in this outcomes study were diagnosed with type 2 diabetes. 

More information on the REDUCE-IT study results can be found at www.amarincorp.com.

ABOUT CARDIOVASCULAR DISEASE
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women.

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

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 from degradation. 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. HLS has in-licensed the exclusive rights to Vascepa for the Canadian market. VASCEPA IS NOT APPROVED IN CANADA.

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. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. 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.

FORWARD LOOKING INFORMATION
This release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. 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. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. 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. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated October 26, 2018, which has been filed on SEDAR and can be accessed at www.sedar.com. Accordingly, readers should not place undue reliance on any forward-looking statements or information. 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.

REFERENCES
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. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
² Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
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 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. J Am Heart Assoc. 2018;7(15):e008740.
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.

SOURCE HLS Therapeutics Inc.

Dave Mason, Investor Relations, HLS Therapeutics Inc., [phone], [email protected]; Gilbert Godin, President and Chief Operating Officer, HLS Therapeutics Inc., [phone] ext101, [email protected]

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