TORONTO - HLS Therapeutics Inc. ('HLS' or the 'Company') (TSX: HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, 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.

HLS in-licensed the exclusive rights to Vascepa for the Canadian market from Amarin Corporation (NASDAQ: AMRN) in 2017.

'Cardiovascular disease is the leading cause of death worldwide and Vascepa provides a new treatment option for healthcare practitioners to enhance cardiovascular protection for the many Canadians at risk of a cardiac event,' said Dr. Jean-Claude Tardif, Cardiologist and Director, Montreal Heart Institute Research Centre.

In the global REDUCE-IT cardiovascular outcomes study, approximately 28 percent of patients in the control arm 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.2 As evidenced by this MACE occurrence, there is a group of patients who, despite controlling their cholesterol on statin therapy, continue to have a high need for additional preventative cardiovascular care. For those adult patients in this group who have elevated serum triglycerides (TG) levels (1.5mmol/L and < 5.6mmol/L) and established cardiovascular disease or diabetes and at least one additional risk factor for cardiovascular disease, Vascepa showed a 25% risk reduction in the first occurrence of major adverse cardiovascular events and is the first drug approved to help reduce this persistent cardiovascular risk in that specified population.

'As approved by Health Canada, Vascepa is intended to address a serious, life-threatening condition for which no drug is currently marketed in Canada, and for which there is substantial evidence of clinical effectiveness of the treatment. These factors led to Health Canada's priority review of the product and now serve as the foundation for Vascepa to be a transformative product for HLS,' said Greg Gubitz, CEO of HLS. 'Looking ahead, we are now in the final phase of preparation for the commercial launch of Vascepa in Canada, which we expect will take place in the mid-February 2020 timeframe.'

Vascepa is the subject of numerous Canadian issued patents and pending patents with expiration dates which could extend to 2039. The eligible patents will be added to Health Canada's Patent Register following receipt of NOC and in accordance with Health Canada's process.

The approval of Vascepa is supported by data from REDUCE-IT2, an 8,179-patient cardiovascular outcomes study that was completed in 2018. REDUCE-IT was the first multinational cardiovascular outcomes study that evaluated the effect of pure and stable EPA therapy as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, had elevated serum triglyceride levels (1.5mmol/L and

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