Company Plans to Commence Phase 2b Study in
Dry Eye Subjects in Late 2020
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (“Aerie”), an
ophthalmic pharmaceutical company focused on the discovery,
development and commercialization of first-in-class therapies for
the treatment of patients with open-angle glaucoma, retinal
diseases and other diseases of the eye, today announced the signing
of an agreement (the “Agreement”) for the acquisition of Avizorex
Pharma, S.L. (“AVX Pharma” or “AVX”), a Spanish ophthalmic
pharmaceutical company developing therapeutics for the treatment of
dry eye disease.
AVX completed a Phase 2a study in dry eye subjects earlier this
year with its lead product candidate, AVX-012. The active
ingredient in AVX-012 is a potent and selective agonist of the
TRPM8 ion channel, a cold sensor and osmolarity sensor that
regulates ocular surface wetness and blink rate. By stimulating
these processes in a physiological manner, TRPM8 agonists have the
potential to restore tear film stability and reduce discomfort in
patients with dry eye. Positive results from the Phase 2a study
support the therapeutic potential of AVX-012 to treat signs and
symptoms of dry eye and Aerie is planning to initiate a larger
Phase 2b study in late 2020.
“This acquisition bolsters our pipeline with a clinical-stage
dry eye product candidate, and we are excited to expand our
footprint in ophthalmology. This product has a novel
mechanism-of-action for treating dry eye and we believe that, if
approved, it could nicely complement the currently approved drugs
for this indication. Since the majority of our efforts in 2020 will
be focused on supportive non-clinical studies, we do not currently
expect to meaningfully increase our R&D expenditures next
year,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive
Officer at Aerie.
AVX Pharma President and Chief Executive Officer Patrick
Tresserras added, “We are thrilled that this transaction will
accelerate the development of AVX-012 towards later stage clinical
trials. Aerie, as a unique ophthalmology focused company with a
track record of developing and commercializing ophthalmic drugs, is
well positioned to fulfill our vision of addressing this indication
from a new mode of action for the benefit of millions of patients
suffering from dry eye disease.”
Under the terms of the Agreement, Aerie will acquire AVX Pharma
in an all-cash transaction. Aerie will make an upfront payment of
$10 million, subject to customary adjustments, and AVX Pharma
shareholders will be eligible to receive additional payments
subject to achievement of certain clinical and regulatory
performance milestones, plus royalties on net sales of approved
products from AVX Pharma’s development pipeline. In addition to
AVX-012, Aerie will also be acquiring rights to other compounds
targeting TRPM8. The parties expect to close the acquisition before
the end of the year pending the completion of certain pre-closing
obligations.
Additional information regarding today’s announcement can be
found in Aerie’s corporate slide presentation which is available at
http://investors.aeriepharma.com.
About Avizorex Pharma, S.L.
AVX Pharma is a Spanish ophthalmic pharmaceutical company
founded in 2013 by Patrick Tresserras and Professor Carlos
Belmonte, as a spin-off company of the University Miguel Hernandez
de Elche, focused on developing novel therapies for dry eye
syndrome. AVX’s technology originated from research conducted by
Professor Carlos Belmonte at the Institute of Neurosciences in
Alicante involving the role of temperature-sensitive neurons in
tear film regulation. The Company, backed by Inveready Innvierte
Biotech II as lead investor, completed a Phase 2a study in dry eye
disease subjects in 2019 with its lead product candidate,
AVX-012.
About Aerie Pharmaceuticals, Inc.
Aerie is an ophthalmic pharmaceutical company focused on the
discovery, development and commercialization of first-in-class
therapies for the treatment of patients with open-angle glaucoma,
retinal diseases and other diseases of the eye. Aerie's first
product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a
once-daily eye drop approved by the U.S. Food and Drug
Administration (“FDA”) for the reduction of elevated intraocular
pressure (IOP) in patients with open-angle glaucoma or ocular
hypertension, was launched in the United States in April 2018. In
clinical trials of Rhopressa®, the most common adverse reactions
were conjunctival hyperemia, corneal verticillata, instillation
site pain, and conjunctival hemorrhage. More information about
Rhopressa®, including the product label, is available at
www.rhopressa.com. Aerie’s second product for the reduction of
elevated intraocular pressure in patients with open-angle glaucoma
or ocular hypertension, Rocklatan® (netarsudil and latanoprost
ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose
combination of Rhopressa® and the widely-prescribed PGA
(prostaglandin analog) latanoprost, has been approved by the FDA
and is now available in the United States. In clinical trials of
Rocklatan®, the most common adverse reactions were conjunctival
hyperemia, corneal verticillata, instillation site pain, and
conjunctival hemorrhage. More information about Rocklatan®,
including the product label, is available at www.rocklatan.com.
Aerie continues to focus on global expansion and the development of
additional product candidates and technologies in ophthalmology,
including for wet age-related macular degeneration and diabetic
macular edema. More information is available at
www.aeriepharma.com.
Forward-Looking Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. We may, in some cases, use terms
such as “predicts,” “believes,” “potential,” “proposed,”
“continue,” “estimates,” “anticipates,” “expects,” “plans,”
“intends,” “may,” “could,” “might,” “will,” “should,” “exploring,”
“pursuing” or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements.
Forward-looking statements in this press release include statements
regarding our intentions, beliefs, projections, outlook, analyses
or current expectations concerning, among other things: our
completion of the acquisition of Avizorex Pharma, S.L., the
success, timing and cost of studies relating to its product
candidates and our ability to recognize growth opportunities in
connection with the acquisition, our expectations regarding the
development, approval, commercialization and manufacturing of any
dry eye product as a result of this acquisition and our expected
R&D expenditures for 2020. By their nature, forward-looking
statements involve risks and uncertainties because they relate to
events, competitive dynamics, industry change and other factors
beyond our control, and depend on regulatory approvals and economic
and other environmental circumstances that may or may not occur in
the future or may occur on longer or shorter timelines than
anticipated. We discuss many of these risks in greater detail under
the heading “Risk Factors” in the quarterly and annual reports that
we file with the Securities and Exchange Commission.
Forward-looking statements are not guarantees of future performance
and our actual results of operations, financial condition and
liquidity, and the development of the industry in which we operate
may differ materially from the forward-looking statements contained
in this press release. Any forward-looking statements that we make
in this press release speak only as of the date of this press
release. We assume no obligation to update our forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20191118005152/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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