• Vascepa included in Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology1 
  • Chinese Society of Cardiology updated Guidelines now include Vascepa in its Prevention of Cardiovascular Diseases 
  • Vascepa is now included in the treatment guidelines or otherwise recommended for use by 13 medical associations worldwide including Thrombosis Canada2-14
  • HLS expects the Canadian Cardiovascular Society will review and potentially update its lipid management guidelines in 2021

TORONTO, Jan. 28, 2021 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announces new support from independent medical societies for the use of Vascepa (icosapent ethyl) in reducing the risk of a Major Adverse Cardiovascular Event (MACE). 

In the recent Consensus Statement by the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology on the Management of Dyslipidemia and Prevention of Cardiovascular Disease Algorithm 2020 executive summary1, the AACE treatment algorithm recommends that Vascepa should be added to a statin for any patient with established atherosclerotic cardiovascular disease (ASCVD) or diabetes with ≥2 ASCVD risk factors and triglycerides between 135 and 499 mg/dL to prevent cardiac events. In addition, on January 21, 2021, it was announced that the Chinese Society of Cardiology had included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases. The guideline authors include "icosapent ethyl 2 grams twice a day (as studied in REDUCE-IT®) as a treatment consideration to further lower ASCVD in the appropriate patient population."15

Vascepa (icosapent ethyl) is now included in the treatment guidelines or otherwise recommended for use by 13 medical associations worldwide.2-14 These include American Diabetes Association; American Heart Association; National Lipid Association; American Association of Clinical Endocrinologists; American College of Endocrinology; Endocrine Society; European Society of Cardiology; European Atherosclerosis Society; Chinese Society of Cardiology; Japan Circulation Society; Brazilian Society of Cardiology; and Thrombosis Canada. HLS expects that the relevant guidelines from the Canadian Cardiovascular Society will be reviewed and may be updated in 2021.

"Cardiovascular disease remains the number one killer worldwide1 and the inclusion of Vascepa in treatment guidelines from leading medical associations across the globe further validates the acceptance of this unique drug to reduce the risk of a MACE in cardiac or diabetic patients," said Gilbert Godin, CEO of HLS. "Vascepa is a first-in-its-class medication and with substantial clinical evidence behind it, we believe that there is an urgent and genuine need for the product in the Canadian market today."

ABOUT VASCEPA (ICOSAPENT ETHYL) CAPSULES

VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment comprised solely of the active ingredient, icosapent ethyl, 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 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

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 November 4, 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.

REFERENCES

1.

Handelsman Y, Jellinger PS, Guerin CK, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Management of Dyslipidemia and Prevention of Cardiovascular Disease Algorithm - 2020 Executive Summary. Endocr Pract. 2020;26(10):1196-1224. doi:10.4158/CS-2020-0490

2.

American Diabetes Association http://main.diabetes.org/dorg/bod/2019-2020/ADA-Strategic-Architecture.pdf

3.

Kimura K, et al. Circ J. 2019;83:1085 -1196

4.

American Heart Association https://www.heart.org

5.

European Society of Cardiology https://www.escardio.org/The-ESC/Who-we-are

6.

European Atherosclerosis Society https://www.eas-society.org/page/about_eas

7.

National Lipid Association https://www.lipid.org/about

8.

American Association of Clinical Endocrinologists https://www.aace.com/disease-stateresources/diabetes/clinical-practice-guidelines-treatment-algorithms/comprehensive

9.

Brazilian Society of Cardiology Cardiovascular Prevention Guideline Update http://publicacoes.cardiol.br/portal/abc/ingles/aop/2019/aop-diretriz-prevencao-cardiovascular-ingles.pdf

10.

The Thrombosis CanadaTM Clinical Guides. Stroke: Secondary Prevention. Accessed on April 13, 2020. URL: https://thrombosiscanada.ca/clinicalguides/#

11.

Vargas-Uricoechea H, et al. Revista ACE. 2020;7(1):4-36, http://revistaendocrino.org/index.php/rcedm

12.

Arnold SV, Bhatt DL, Barsness GW, et al; on behalf of the American Heart Association Council on Lifestyle and Cardiometabolic Health and Council on Clinical Cardiology. Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association. Circulation. 2020;141:e000–e000. doi: 10.1161/CIR.0000000000000766

13.

Collet JP, et al. EHJ, ehaa575, https://doi.org/10.1093/eurheartj/ehaa575.

14.

Newman C, Blaha MJ, Boord JB, Cariou B, Chait A, Fein H, Ginsberg H, Goldberg I, Murad MH, Subramanian S, Tannock LR. Lipid Management in Patients with Endocrine Disorders: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2020 Sep 19:dgaa674. doi: 10.1210/clinem/dgaa674. Epub ahead of print. PMID: 32951056. Dated Oct 29, 2020

15.

Cardiology Committee of the National Medical Association, et al. Guidelines for Primary Prevention of Cardiovascular Diseases in China. Chinese Journal of Cardiovascular Diseases. 2020;48(12):1000-1038.

SOURCE HLS Therapeutics Inc.

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