Aequus Prepares for Health Canada Regulatory Filing as Partner Receives MDSAP Certificate for Dry Eye Products
Aequus will complete the regulatory filing for approval with Health Canada for three Dry Eye Disease products within 10 days
VANCOUVER, August 31st, 2020 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, is pleased to announce its partner, Medicom Healthcare, the UK manufacturer of Evolve® products, received the final certificate for the Canadian Medical Device Single Audit Program (MDSAP) required to complete the Health Canada regulatory submission for the Evolve® dry eye products in Canada.
Within the next 10 days, Aequus expects to be filing for regulatory approval of the first three dry eye products in the Evolve® line. These dry eye drops will be filed as New Class II medical devices with Health Canada, with an anticipated review time of up to 30 days following the submission.
“Over the past months, the marketing team has worked diligently to prepare for the launch of Evolve in Canada,” said Doug Janzen, CEO and Chairman of Aequus. “It was a long and frustrating wait for us and our partners at Medicom, but the time was well utilized and we are ready to hit the ground running. We are excited to have received this final piece required for the regulatory submission with Health Canada and look forward to providing dry eye patients in Canada with this exceptional line of products in the near future.”
ABOUT AEQUUS PHARMACEUTICALS INC.
Aequus Pharmaceuticals Inc. (TSX-V:AQS) (OTCQB:AQSZF) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus has grown its pipeline to include several commercial products in ophthalmology and transplant, and a development stage pipeline in neurology. For further information, please visit www.aequuspharma.ca
This release may contain forward-looking statements or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “potential” and similar expressions. Forward- looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements include but are not limited to statements relating to: the continuation of supply of our partnered products, the expected launch date of our dry-eye products, the impact of the novel coronavirus (COVID-19) on our ongoing business operations. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Aequus, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements. In making the forward looking statements included in this release, the Company has made various material assumptions, including, but not limited to: obtaining regulatory approvals; general business and economic conditions; the ability of its manufacturer and other third party manufacturers to continue supplying Vistitan and tacrolimus without interruption; the Company’s ability to attract and retain skilled staff; market competition; and the products and technology offered by the Company’s competitors. In evaluating forward looking statements, current and prospective shareholders should specifically consider various factors set out herein and under the heading “Risk Factors” in the Company’s Annual Information Form dated April 30, 2018, a copy of which is available on Aequus’ profile on the SEDAR website at www.sedar.com, and as otherwise disclosed from time to time on Aequus’ SEDAR profile. Should one or more of these risks or uncertainties, or a risk that is not currently known to us materialize, or should assumptions underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by applicable securities laws. Investors are cautioned that forward-looking statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward looking statements.
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