Aequus Prepares for Health Canada Regulatory Filing as Partner Receives MDSAP Certificate for Dry Eye Products
August 31 2020 - 7:30AM
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.
Forward-Looking Statements
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 the successful launch of addition of
products to the Company’s portfolio. 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 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 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.
Aequus Contact Information: Aequus Investor
Relations Email: investors@aequuspharma.ca Phone:
604-336-7906
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