Aerie Pharmaceuticals Enters into Lease Agreement for New Manufacturing Plant in Ireland
09 January 2017 - 10:30PM
Business Wire
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage
pharmaceutical company focused on the discovery, development and
commercialization of first-in-class therapies for the treatment of
glaucoma and other diseases of the eye, today announced that it has
entered into a lease agreement with the Industrial Development
Agency (IDA) of Ireland for a new manufacturing plant in Athlone,
Ireland. This will be Aerie’s first manufacturing plant, expected
to produce commercial supplies of Aerie’s current product
candidates, Rhopressa™ and Roclatan™. The Athlone building shell,
which was recently constructed by the IDA, includes approximately
30,000 square feet of interior floor space. The IDA has provided
employment and capital investment incentives to Aerie as part of
the overall arrangement. Aerie has commenced equipment ordering and
will begin internal construction immediately. Estimated
project-wide construction and equipment costs are expected to total
approximately $25 million (excluding ongoing labor-related and
lease expenses), of which approximately $16 million is expected to
be spent in 2017. If approved, commercial product supply of
Rhopressa™ from the plant is expected to be available by 2020.
“We have now achieved another milestone in executing our stated
long-term strategy. As we prepare for commercialization, it is
increasingly important that we ensure greater independence
regarding our finished product sourcing while also meaningfully
reducing our future product costs. We are grateful to our IDA
colleagues in Ireland for their cooperation throughout this process
and the incentives that we have been granted,” said Vicente Anido,
Jr., Ph.D., Chief Executive Officer and Chairman at Aerie.
About Aerie Pharmaceuticals, Inc.
Aerie is a clinical-stage pharmaceutical company focused on the
discovery, development and commercialization of first-in-class
therapies for the treatment of patients with glaucoma and other
diseases of the eye. Aerie's two lead product candidates are
once-daiIy IOP-lowering therapies with novel mechanisms of action
to treat patients with glaucoma or ocular hypertension. The NDA
filing for Rhopressa™ (netarsudil ophthalmic solution) 0.02% was
originally submitted in the third quarter of 2016 and is expected
to be resubmitted near the end of the first quarter of 2017. The
second product candidate, Roclatan™ (netarsudil/latanoprost
ophthalmic solution) 0.02%/0.005%, which is a fixed dose
combination of Rhopressa™ and widely prescribed PGA latanoprost,
currently has two Phase 3 registration trials underway, named
Mercury 1 and Mercury 2. If these trials are successful, a
Roclatan™ NDA filing is expected to take place near year-end 2017.
Aerie is also focused on the development of additional product
candidates and technologies in ophthalmology.
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: the success, timing
and cost of our ongoing and anticipated preclinical studies and
clinical trials for our current product candidates, including
statements regarding the timing of initiation and completion of the
studies and trials; our expectations regarding the clinical
effectiveness of our product candidates and results of our clinical
trials; the timing of and our ability to obtain and maintain U.S.
Food and Drug Administration or other regulatory authority approval
of, or other action with respect to, our product candidates,
including the expected timing of NDA filings for our product
candidates; our expectations regarding the commercialization of our
product candidates and our future manufacturing capabilities,
including the expected cost and timing related thereto; the
potential advantages of our product candidates; our plans to pursue
development of our product candidates for additional indications
and other therapeutic opportunities; our plans to explore possible
uses of our existing proprietary compounds beyond glaucoma; our
ability to protect our proprietary technology and enforce our
intellectual property rights; and our expectations regarding
strategic operations, including our ability to in-license or
acquire additional ophthalmic products or product candidates. By
their nature, forward-looking statements involve risks and
uncertainties because they relate to events, competitive dynamics
and industry change, and depend on regulatory approvals and
economic 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). 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: http://www.businesswire.com/news/home/20170109005027/en/
Aerie PharmaceuticalsRichard Rubino,
908-947-3540rrubino@aeriepharma.comorBurns McClellan, Inc., on
behalf of Aerie PharmaceuticalsInvestorsAmi Bavishi,
212-213-0006abavishi@burnsmc.comorMediaJustin Jackson,
212-213-0006jjackson@burnsmc.com
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