Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the
Company), 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, today announced that it has received
notification by its contract drug product manufacturer that the
contract manufacturer has received a Complete Response Letter (CRL)
from the U.S. Food and Drug Administration (FDA) regarding the
contract manufacturer’s New Drug Application (NDA) for one of their
own product candidates manufactured at their Tampa, Florida
facility. According to the contract manufacturer, the CRL refers to
a Current Good Manufacturing Practice (CGMP) inspection at the
facility. The contract manufacturer has stated that they will work
closely with the FDA to determine the appropriate next steps.
This facility also manufactures on a contract basis Aerie’s
product candidate Rhopressa™ (netarsudil ophthalmic solution)
0.02%, which has a Prescription Drug User Fee Act (PDUFA) goal date
of February 28, 2018. Based on Aerie's understanding of the
contract manufacturer’s CAPA (Corrective and Preventative Actions)
and other activities at the manufacturing site, and PDUFA dates
later in 2017 for other products manufactured at that site, we
currently believe it is probable that open issues will be resolved
prior to the February 28, 2018 PDUFA date for Rhopressa™.
About Rhopressa™
Rhopressa™ (netarsudil ophthalmic solution) 0.02%, is a novel
eye drop that the Company believes, if approved, would become the
only once-daily product available that, based on Aerie’s
preclinical and clinical studies to date, specifically targets the
trabecular meshwork, the eye’s primary fluid drain and the diseased
tissue responsible for elevated intraocular pressure (IOP) in
glaucoma. Preclinical and clinical studies have also demonstrated
that Rhopressa™ lowers episcleral venous pressure, which
contributes approximately half of IOP in healthy subjects. Further,
based on Aerie’s preclinical studies, Rhopressa™ may provide an
additional mechanism that reduces fluid production in the eye and
therefore lowers IOP. Biochemically, the active ingredient in
Rhopressa™, netarsudil, has been shown in Aerie studies to inhibit
both Rho kinase (ROCK) and norepinephrine transporter (NET). Recent
preclinical studies have also shown that Rhopressa™ may have
disease-modifying properties, including an anti-fibrotic effect of
netarsudil on trabecular meshwork cells and the potential to
increase perfusion of the trabecular meshwork.
The results of two Phase 3 registration trials (Rocket 2 and
Rocket 1) for Rhopressa™ were included in the NDA submission to the
FDA in February 2017. There were two additional Phase 3
registration trials for Rhopressa™, named Rocket 3 and Rocket 4.
Rocket 3 was a small 12-month safety-only study in Canada that was
not necessary for the NDA submission and for which enrollment has
been discontinued. Rocket 4, which was successfully completed in
April 2017, was designed to provide adequate six-month safety data
for regulatory filing purposes in Europe, and was also not
necessary for the NDA submission. The 90-day efficacy results from
Rocket 4 and Mercury 1, the initial Phase 3 registration trial for
Aerie product candidate Roclatan™ (netarsudil/latanoprost
ophthalmic solution) 0.02%/0.005%, were also included in the
Rhopressa™ NDA submission as supportive. The FDA has set the
Prescription Drug User Fee Act (PDUFA) goal date for the completion
of the FDA’s review of the Rhopressa™ NDA for February 28,
2018.
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 current product candidates are
once-daily intraocular pressure lowering therapies with novel
mechanisms of action to treat patients with glaucoma or ocular
hypertension. The NDA for Rhopressa™ (netarsudil ophthalmic
solution) 0.02% was submitted to the FDA in February 2017, and, in
May 2017, the FDA set the PDUFA goal date for the completion of the
FDA’s review of the Rhopressa™ NDA for February 28, 2018. Aerie’s
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,
achieved its primary efficacy endpoint in two Phase 3 registration
trials, named Mercury 1 and Mercury 2, and also achieved successful
12-month safety and efficacy results in Mercury 1. The Roclatan™
NDA submission is expected to take place in the first half of 2018.
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 and potential future 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
request, obtain and maintain FDA or other regulatory authority
approval of, or other action with respect to, our product
candidates, including the expected timing of, and timing of
regulatory and/or other review of, filings for our product
candidates; our expectations regarding the commercialization and
manufacturing of our product candidates; the potential advantages
of our product candidates; our plans to pursue development of
additional product candidates and technologies in ophthalmology,
including 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 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, the receipt of the
PDUFA goal date notification does not constitute FDA approval of
the Rhopressa™ NDA, and there can be no assurance that the FDA will
complete its review by the PDUFA goal date, that the FDA will not
require changes or additional data, whether as a result of
recommendations, if any, made by any FDA advisory committee or
otherwise, that must be made or received before it will approve the
NDA, if ever, or that the FDA will approve the NDA. In addition,
our expectations discussed in this press release regarding our
contract drug product manufacturer and the vendor’s Tampa, Florida
facility are based on our current understanding of the contract
manufacturer’s CAPA and other activities at the manufacturing site,
and there can be no assurance that any open issues will be resolved
prior to the PDUFA goal date for Rhopressa™ or that there will not
be any consequential delays to the Rhopressa™ approval timeline.
Further, the preclinical research discussed in this press release
is preliminary and the outcome of such preclinical studies may not
be predictive of the outcome of later clinical trials. Any future
clinical trial results may not demonstrate safety and efficacy
sufficient to obtain regulatory approval related to the preclinical
research findings discussed in this press release. 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/20170808006293/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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