VANCOUVER, British Columbia, April 21, 2020 (GLOBE NEWSWIRE) — 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 a positive update on the regulatory and launch advancement for the Evolve® line of preservative free dry eye products into Canada.
Medicom Healthcare, the UK manufacturer of Evolve® products, has received a positive outcome of the Audit to meet standards for the Canadian Medical Device Single Audit Program (MDSAP). The MDSAP, fully implemented by Health Canada in January 2019, establishes a new audit standard for all medical device manufacturers who distribute in Canada, including those with existing marketed products. As a result, there has been a large demand for the completion of audits and delays have been experienced across the industry. Aequus is pleased that the Medicom audit met the Canadian regulatory standards and we are excited to have this important regulatory step achieved for these new-to-the Canadian market medical devices.
As the auditing bodies prepare the formal MDSAP certificate, Canadian launch planning is fully underway. Adaptability to the current and coming circumstances as a result of the COVID-19 pandemic is being integrated into strategic business models. These include the development of an e-commerce distribution channel for product access during self-isolation, as well as establishment of strategic B2B partnerships for clinical distribution as return to work in the healthcare sector is enabled, which will bolster our existing “boots on the ground” sales infrastructure.
“During this time, Aequus is working diligently to prepare for a new normal, by crafting innovative models that integrate existing retail structures, with more wide-reaching virtual channels,” said Anne Stevens, COO and Director of Aequus. “These models will virtually support Canadian optometry clinic retailers who have been forced to close during the pandemic, while simultaneously expanding the availability of Evolve® products to patients at launch.”
No issues with the supply chain for Evolve® products are anticipated, as Medicom continues to manufacture and distribute to 35 countries, and has been further developing and launching new products during this period.
Aequus looks forward to providing Canadian patients and clinicians with the Evolve® range of dry eye products and expects to file for approval with Health Canada upon receipt of the formal MDSAP certificate, expected in June or Q3. The Company will be providing separate updates on additional progress and access to new dry eye products in the coming weeks.
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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