Aequus Announces Canadian Filing of NDS for Preservative-Free Glaucoma Medication
06 Januar 2022 - 3:00PM
Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF), ) (“Aequus”
or the “Company”), a specialty pharmaceutical company announced
today that it has submitted a New Drug Submission (NDS) application
to Health Canada for preservative-free bimatoprost 0.03% eye drops
termed ‘Zimed PF’. At this stage, Health Canada has accepted the
submission for Screening.
“For the first time, a preservative-free glaucoma eye drop, in a
multi-dose format, has been submitted for review to Health Canada,”
says Doug Janzen, Chairman and CEO at Aequus. “We are proud to be
the first to take on a submission of this type, and further expand
our commitment to innovative and value-added ocular therapies in
Canada.”
The ZimedTM PF formulation was selected based on extensive
clinical data demonstrating the efficacy and safety of the
bimatoprost molecule and 0.03% concentration for the reduction of
intraocular pressure in patients with ocular hypertension or
glaucoma. Upon approval, this preservative-free formulation, will
also provide eye care professionals a new option for patients who
are sensitive to preservatives or have ocular surface disease.
“Preservative-free glaucoma medications in multi-dose bottles
have been well-received by eye care professionals in many countries
around the world. ZimedTM PF will provide an environmentally- and
patient-friendly format, compared to glaucoma medications only
available in single use, plastic ampoules,” says Grant Larsen, CCO
at Aequus.
According to Health Canada, the target review time for an NDS is
355 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
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.
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 implementation of our business model
and strategic plans; revenue growth trends into the future;
expected timing for product launches; the Company’s expected
revenues; the regulatory approval of its products; the Company’s
ability to attract international partners; and ongoing discussions
with and the Company’s ability to secure potential partners to
further grow our product 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
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 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; the impact of the coronavirus (COVID-19) on
the Company’s operations; 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, 2021, 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 RelationsEmail:
investors@aequuspharma.caPhone: 604-336-7906
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