Aequus Announces Filing of New Medical Device License for Evolve Dry Eye Products in Canada
September 14 2020 - 11:51AM
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.
ABOUT EVOLVE
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.
CONTACT INFORMATION Aequus Investor Relations
Email: investors@aequuspharma.ca Phone: 604-336-7906
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