News

• In vitro data presented provides additional insight into potential mechanisms by which Vascepa reduces cardiovascular risk

TORONTO, Oct. 22, 2020 /CNW/ - "The Vascepa story continues to unfold as we learn more about how icosapent ethyl acts on a cellular level," said Gilbert Godin, President and CEO of HLS Therapeutics. "The new in vitro data presented at CCC may help us to further understand the possible ways by which Vascepa works."

Vascepa is indicated to reduce the risk of cardiovascular events⁴, in statin-treated patients with elevated triglycerides with established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. The three poster presentations contribute novel insights into icosapent ethyl that include:

• Icosapent ethyl reduces cellular inflammation¹, which may be a factor in plaque regression in the arteries as seen in the EVAPORATE⁵ trial that enrolled both diabetic and non-diabetic high-risk patients.
• Icosapent ethyl may improve the activity of human blood vessels, compared to the impact from other omega-3 fatty acids².  These vascular benefits of icosapent ethyl may potentially lead to reduced clot formation and plaque stabilization.
• Icosapent ethyl and statins may work hand-in-hand to reduce oxidative stress, inflammation and cholesterol removal from the cells through preserved HDL, or "good cholesterol", function.³

Also featured in the Canadian and International Perspectives on late breaking Clinical Trials at the CCC will be a presentation on Vascepa's landmark REDUCE IT trial⁶ by Dr. Deepak L. Bhatt MD MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and Professor, Harvard Medical School and Dr. Erin D. Michos MD MHS FAHA FACC FASE FASPC, Director of Women's Cardiovascular Health at Johns Hopkins University School of Medicine.

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. For more information, please visit: www.hlstherapeutics.com

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. Vascepa was approved by Health Canada, was added to Health Canada's Register of Innovative Drugs and benefits from data protection for a term of eight years, as well as being the subject of multiple issued and pending patents based on its unique clinical profile. HLS in-licensed the exclusive rights to Vascepa for the Canadian market from Amarin Corporation (NASDAQ:AMRN).

ABOUT THE CANADIAN CARDIOVASCULAR CONGRESS
Hosted by the Canadian Cardiovascular Society and Heart & Stroke, the Canadian Cardiovascular Congress (CCC) is being held virtually Wednesday, October 21 to Saturday, October 24, 2020 and is the largest gathering of cardiovascular and allied health professionals in Canada.

REFERENCES

[1] "Eicosapentaenoic Acid, Unlike Other Omega-3 Fatty Acids, Inhibits Membrane Cholesterol Domains under Conditions of Hyperglycemia as Determined by X-ray Diffraction" Samuel C.R. Sherratt, Deepak L. Bhatt, R. Preston Mason; Poster presented at The Canadian Cardiology Congress; Oct 21, 2020; Virtual Edition
[2] "Omega-3 Fatty Acid Eicosapentaenoic Acid (EPA), but not Docosahexaenoic Acid (DHA), Improved Nitric Oxide Bioavailability in Human Endothelial Cells" R. Preston Mason, Hazem Dawoud, Samuel C.R. Sherratt, Deepak L. Bhatt, Tadeusz Malinski; Poster presented at The Canadian Cardiology Congress; Oct 21, 2020; Virtual Edition
[3] "Inhibition of High Density Lipoprotein (HDL) Oxidation by Eicosapentaenoic Acid (EPA) is Enhanced in Combination with a Statin In Vitro" Samuel C.R. Sherratt, Deepak L. Bhatt, R. Preston Mason; Poster presented at The Canadian Cardiology Congress; Oct 21, 2020; Virtual Edition
[4] HLS Therapeutics. (Dec 2019), Vascepa Capsules (icosapent ethyl), Canadian Product Monograph
[5] Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
[6] Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11–22. doi:10.1056/NEJMoa1812792

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 March 18, 2020 and Management's Discussion and Analysis dated May 6, 2020, both of which have 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.

SOURCE HLS Therapeutics Inc.