Aequus Announces Filing of New Medical Device License for Evolve Dry Eye Products in Canada
VANCOUVER, September 14th, 2020 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company announced today that it has submitted New Medical Device License (“MDL”) applications for two dry eye products in the Evolve® range. Aequus and Medicom entered into a license agreement in March 2019, granting Aequus exclusive rights to commercialize the Evolve® product line in Canada.
“Today marks an important milestone for Aequus, as these are our first licensed products we submit to Health Canada as an organization, versus partnered products we support with promotional efforts only. The two products included in this initial multi-product submission for Evolve were selected to provide a range of solutions for patients with varying intensities of dry eye,” said Doug Janzen, Chairman and CEO of Aequus. “We are looking forward to bringing the Evolve dry eye line into Canada, which reinforces our responsiveness to physician and patient feedback on the need for more preservative free options. With this launch, we will further enrich our offering and commitment in the eye care space in Canada.”
“The medical eyecare market has a growing need for products that lead to better outcomes for patients and the physicians that treat them,” said Grant Larsen, Chief Commercial Officer at Aequus. “The Evolve range of products are proven and have been very successful in other markets including the UK and Europe. We are ready to launch and look forward to bringing these products to Canada.”
The two Evolve® products were submitted for approval with Health Canada as Class II medical devices. According to Health Canada, the target review time for a Class II MDL application is typically 20 days. Aequus is moving ahead with plans in accordance with this timeline but acknowledges that review timing may be affected by factors out of our control such as backlogs caused by COVID-19.
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 sales and marketing efforts to include several commercial products in ophthalmology and transplant. Aequus plans to build on its Canadian commercial platform through the launch of additional products that are either created internally or brought in through an acquisition or license; remaining focused on highly specialized therapeutic areas. For further information, please visit www.aequuspharma.ca.
Launched in 2015 in Europe, the Evolve® brand has grown to 5 products across 35 countries. With an array of products, the brand can address the various symptoms involved with dry eye disease and blepharitis including discomfort, stinging, burning, and dryness. Currently in Canada, the dry eye market is estimated at over $90M, which includes both prescription and over-the-counter products.
FORWARD-LOOKING STATEMENT DISCLAIMER
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 implementation of our business model and strategic plans; revenue growth trends into the future; expected timing for product launch; the Company’s expected revenues; the regulatory approval of the Evolve line of products expected in 2020. 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 positive results of clinical trials; obtaining regulatory approvals; general business and economic conditions; the Company’s ability to successfully out license or sell its current products and in-license and develop new products; the assumption that the Company’s current good relationships with its manufacturer and other third parties will be maintained; the availability of financing on reasonable terms; the Company’s ability to attract and retain skilled staff; market competition; the products and technology offered by the Company’s competitors; and the Company’s ability to protect patents and proprietary rights. 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 28, 2020, 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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