Aerie Pharmaceuticals Announces Appointment of Damien Monaghan, Quality Director
September 24 2018 - 6:30AM
Business Wire
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), 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, retina diseases and other
diseases of the eye, today announced the appointment of Damien
Monaghan, Quality Director, reporting to Finbar O’Neill, EU
Director, Quality & Regulatory Compliance. Mr. Monaghan will
lead quality assurance and quality control operations for Aerie’s
manufacturing plant in Athlone, Ireland. Mr. Monaghan most recently
held a related position at Alkermes Pharma Ireland Limited.
In connection with his acceptance of the position as Quality
Director, Mr. Monaghan will receive awards totaling 14,400 stock
options that will vest over 4 years, with 25% vesting on the first
anniversary of the hire date and the remainder vesting ratably on
each of the subsequent 36 monthly anniversaries of the hire date.
This award was made outside of Aerie’s stockholder-approved equity
incentive plan and was approved by the Company’s independent
directors as an inducement material to Mr. Monaghan entering into
employment with the Company in reliance on NASDAQ Listing Rule
5635(c)(4), which requires this public announcement.
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,
retina diseases and other diseases of the eye. Aerie's first
product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a
once-daily eyedrop 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, cornea verticillata, instillation site
pain, and conjunctival hemorrhage. More information about
Rhopressa®, including the product label, is available at
www.rhopressa.com. Aerie’s advanced-stage product candidate,
Roclatan™ (netarsudil/latanoprost ophthalmic solution)
0.02%/0.005%, a fixed-dose combination of Rhopressa® and the
widely-prescribed PGA (prostaglandin analog) latanoprost,
achieved its 3-month primary efficacy endpoint in two Phase 3
registration trials, Mercury 1 and Mercury 2, and also showed
safety and efficacy throughout 12 months in Mercury 1. Aerie
submitted the Roclatan™ New Drug Application (NDA) in May 2018
and, in July 2018, the FDA set the PDUFA (Prescription Drug User
Fee Act) goal date for the completion of the FDA’s review of the
Roclatan™ NDA for March 14, 2019. 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 include statements regarding our
intentions, beliefs, projections, outlook, analyses or current
expectations concerning, among other things: our expectations
regarding the commercial launch and sales of Rhopressa® and
Roclatan™ and any future product candidates, if approved; our
commercialization, marketing, manufacturing and supply management
capabilities and strategies; third-party payer coverage and
reimbursement of Rhopressa® and Roclatan™ and any future product
candidates, if approved; the glaucoma patient market size and the
rate and degree of market adoption of Rhopressa® and Roclatan™ and
any future product candidates, if approved, by eye-care
professionals and patients; the timing cost or other aspects of the
commercial launch of Rhopressa® and Roclatan™ and any future
product candidates, if approved; the success, timing and cost of
our ongoing and anticipated preclinical studies and clinical trials
for Rhopressa®, with respect to regulatory approval outside the
United States, and Roclatan™ and any future product candidates,
including statements regarding the timing of initiation and
completion of the studies and trials; our expectations regarding
the effectiveness of Rhopressa®, Roclatan™ and any future product
candidates and results of our clinical trials and any potential
preclinical studies; the timing of and our ability to request,
obtain and maintain FDA or other regulatory authority approval of,
or other action with respect to, as applicable, Rhopressa®,
Roclatan™ and any future product candidates in the United States,
Canada, Europe, Japan and elsewhere, including the expected timing
of, and regulatory and/or other review of, filings for, as
applicable, Rhopressa®, Roclatan™ and any future product
candidates; the potential advantages of Rhopressa®, Roclatan™ and
any future product candidates; our plans to pursue development of
additional product candidates and technologies in ophthalmology,
including development of Rhopressa® and Roclatan™ for additional
indications, our preclinical retina programs and other therapeutic
opportunities; our plans to explore possible uses of our existing
proprietary compounds beyond glaucoma and ophthalmology; our
ability to protect our proprietary technology and enforce our
intellectual property rights; and our expectations regarding
collaborations, licensing, acquisitions and strategic operations,
including our ability to in-license or acquire additional
ophthalmic products, product candidates or technologies. 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 (SEC). In particular, FDA approval of
Rhopressa® does not constitute FDA approval of Roclatan™, and there
can be no assurance that we will receive FDA approval for Roclatan™
or any future product candidates. FDA approval of Rhopressa® also
does not constitute regulatory approval of Rhopressa® in
jurisdictions outside the United States, and there can be no
assurance that Rhopressa® will obtain regulatory approval in other
jurisdictions. Our receipt of a Prescription Drug User Fee Act
(PDUFA) goal date notification for Roclatan™ does not constitute
FDA approval of the Roclatan™ New Drug Application (NDA), and there
can be no assurance that the FDA will complete its review by the
PDUFA goal date of March 14, 2019, that the FDA will not require
changes or additional data that must be made or received before it
will approve the NDA, if ever, or that the FDA will approve the
NDA. 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/20180924005004/en/
Aerie PharmaceuticalsMedia:Tad
Heitmann, 949-526-8747theitmann@aeriepharma.comorInvestors:Richard
Rubino, 908-947-3540rrubino@aeriepharma.comorBurns McClellan, Inc., on behalf of Aerie
PharmaceuticalsInvestors:Ami Bavishi,
212-213-0006abavishi@burnsmc.com
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