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HLS Therapeutics Comments on U.S. District Court Decision on Amarin Patents

TORONTO, March 31, 2020 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, comments on the United States District Court for the District of Nevada's ruling in favor of the generic companies in Amarin Corporation plc's ("Amarin") patent litigation against two generic filers for Amarin's VASCEPA® (icosapent ethyl). HLS has in-licensed the exclusive rights to VASCEPA for the Canadian market from Amarin.

HLS seeks to clarify that this litigation and judgment do not impact VASCEPA in Canada:

  • VASCEPA was added to Health Canada's Register of Innovative Drugs in January 2020 and benefits from eight years of data protection until December 2027.
  • VASCEPA is also the subject of numerous Canadian issued patents and pending patents that were not part of the U.S. litigation and that could extend to 2039.
  • No litigation is pending in Canada regarding VASCEPA.

"This court ruling in the U.S. does not affect the Canadian business for VASCEPA or our growth outlook for the product," said Greg Gubitz, CEO of HLS. "Since our launch several weeks ago, we continue to move forward on our plan to bring a new and unique treatment option to the many Canadians who suffer from cardiovascular disease, the world's number one killer."

To view Amarin's response to the court's ruling, please see their press release dated March 30, 2020 titled, "Amarin Comments on Ruling in VASCEPA® ANDA Litigation".

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, 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.

SOURCE HLS Therapeutics Inc.

For further information: Dave Mason, Investor Relations, HLS Therapeutics Inc., (416) 247-9652, dave.mason@loderockadvisors.com; Gilbert Godin, President and Chief Operating Officer, HLS Therapeutics Inc., (484) 232-3400 ext101, g.godin@hlstherapeutics.com