Aerie Pharmaceuticals Announces U.S. Food & Drug Administration Approval of its Athlone, Ireland Facility for Production of R...
January 21 2020 - 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, dry eye, retinal diseases and
other diseases of the eye today announced that its sterile fill
production facility in Athlone, Ireland has received approval from
U.S. Food and Drug Administration (FDA) to produce Rocklatan®
(netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for
the U.S. market. The regulatory clearance of the plant follows a
successful preapproval inspection of the facility and FDA review of
the New Drug Application Prior Approval Supplement (PAS), which
added the Athlone production facility as a drug product
manufacturer for Rocklatan®.
“I want to personally thank each and every employee for a job
very well done. This is a very proud moment for our company, the
culmination of a dream we first had in 2015 to better control our
own destiny from a manufacturing standpoint,” said Vicente Anido,
Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “It is
certainly not every day that a new, state-of-the-art pharmaceutical
production facility comes on line, a career-high achievement for
every member of the Athlone team and the Aerie departments that
supported their work. Their accomplishment is even more remarkable
because of the project’s highly accelerated timeline. Design and
construction of this facility was only initiated in 2017, in an
empty building shell, but by early 2019 the facility had
successfully completed Rocklatan® process validation batches,
enabling our PAS to be submitted with the FDA in September. We aim
to have Rhopressa® produced in Athlone later in 2020, and
eventually, we anticipate that Athlone will supply our ophthalmic
products for all the markets in which we will operate.”
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,
dry eye, 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 IOP 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, was approved by the FDA and was launched in the United
States in the second quarter of 2019. 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 dry eye, 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 commercialization and manufacturing of, as
applicable, Rhopressa®, Rocklatan®, Rhokiinsa®, Roclanda® or any
current or future product candidates, including the timing, cost or
other aspects of their commercial launch or commercialization,
marketing, manufacturing and supply management capabilities and
strategies in and outside the United States; the success, timing
and cost of our ongoing and anticipated preclinical studies and
clinical trials for Rhopressa® and Rocklatan® with respect to
regulatory approval outside of the United States or additional
indications, and any current or future product candidates,
including statements regarding the timing of initiation and
completion of the studies and trials; our expectations regarding
the effectiveness of Rhopressa®, Rocklatan® or any current or
future product candidates; 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®, Rocklatan® or any current or future product candidates,
including the expected timing of, and timing of regulatory and/or
other review of, filings for, as applicable, Rhopressa®,
Rocklatan®, Rhokiinsa®, Roclanda® or any current or future product
candidates; the potential advantages of Rhopressa® and Rocklatan®
or any current or future product candidates; our plans to pursue
development of additional product candidates and technologies
within and beyond ophthalmology; our plans to explore possible uses
of our existing proprietary compounds beyond glaucoma, including
development of our retina program; 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, product candidates or technologies. In
particular, statements in this press release regarding our Athlone,
Ireland facility are forward looking statements. In addition, FDA
approval of Rhopressa® and Rocklatan® and EMA approval of
Rhokiinsa® do not constitute regulatory approval of Rhopressa® and
Rocklatan® in other jurisdictions, including EMA approval of
Roclanda®, and there can be no assurance that we will receive
regulatory approval for Rhopressa® and Rocklatan® in such other
jurisdictions, including EMA approval of Roclanda®. Furthermore,
EMA acceptance of the MAA for Roclanda® does not constitute
regulatory approval of Roclanda® by the EMA, and there can be no
assurance that we will receive regulatory approval of Roclanda® by
the EMA. 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). 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/20200121005233/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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