Focused on Novel Delivery Technologies for Aerie Product Candidates
IRVINE, Calif. & BALTIMORE--(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
patients with glaucoma and other diseases of the eye, and GrayBug, Inc.,
a venture-stage pharmaceutical company developing microparticle
controlled release drug delivery technologies for the treatment of
ocular diseases including wet age-related macular degeneration (AMD) and
glaucoma, today announced a research collaboration and license agreement
to deliver certain of Aerie's preclinical product candidates to both the
front and back of the eye using GrayBug's proprietary technology.
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Initially, the partnership will focus on evaluating the ability of
GrayBug's polymer-based delivery technology to provide multi-month
drug release capability for an Aerie small molecule for wet AMD.
Pre-clinical in vivo studies showed that Aerie's AR-13154 molecule
reduced wet AMD lesion size more than the market-leading product Eylea®
(aflibercept). AR-13154 targets Rho Kinase, Janus Kinase 2, and
platelet-derived growth factor receptor beta.
The research collaboration also provides Aerie with the ability to
evaluate long-term sustained delivery of the active ingredient in
RhopressaTM to the anterior chamber of the eye for patients
with glaucoma and ocular hypertension.
The terms of the agreement provide for a one-year research
collaboration and include an exclusive option for Aerie to obtain from
GrayBug an exclusive license to use the GrayBug technology to develop
and commercialize sustained-release versions of Aerie's ophthalmic
"We are delighted to collaborate with GrayBug, and we believe their
technologies will provide Aerie with the ability to make excellent
progress in understanding the potential of Aerie's small molecules to
provide new treatment approaches to serious diseases of the eye.
AR-13154 has shown impressive results pre-clinically, and we believe the
best way to provide sustained delivery of this product to the back of
the eye is through GrayBug's unique delivery platform. We are also
interested in further evaluating front of the eye applications for our
glaucoma product set," said Vicente Anido, Jr., Ph.D., Aerie's Chairman
and Chief Executive Officer.
Jeffrey L. Cleland, Ph.D., GrayBug Interim Chief Executive Officer,
commented, "We believe Aerie is an excellent partner to apply our unique
delivery technologies for practical application in the treatment of
serious ocular diseases. GrayBug has an extensive background in
polymer-based delivery technologies including the ability to formulate
different release profiles and we believe we have unparalleled potential
to drive sustained delivery of Aerie's products to both the front and
back of the eye."
Under the terms of the license agreement, GrayBug will receive
development milestone payments from Aerie and will receive royalty
payments upon successful commercialization of any products arising from
the collaboration. Initial commitments, including research and execution
investments, are not considered material to Aerie's financial statements
at this time.
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 is currently conducting a Phase 3 registration trial in the
United States named Rocket 2, where the primary efficacy endpoint is to
demonstrate non-inferiority of IOP lowering for RhopressaTM compared
to timolol, along with a Phase 3 registration safety-only trial, named
Rocket 3, in Canada. Aerie completed its initial Phase 3 registration
trial, named Rocket 1, the three-month efficacy results of which were
initially reported in April 2015, and expects to commence a fourth Phase
3 registration trial, named Rocket 4, in the third quarter of 2015.
Aerie also completed in 2014 a Phase 2b clinical trial in which RoclatanTM
met the primary efficacy endpoint, demonstrating the statistical
superiority of RoclatanTM to each of its components, and
plans to commence the first Phase 3 registration trial for RoclatanTM,
named Mercury 1, in the third quarter of 2015.
About GrayBug, Inc.
GrayBug was founded in September 2011 as a spin-out of the Wilmer Eye
Institute of the Johns Hopkins University School of Medicine. GrayBug is
developing injectable controlled release technologies to reduce the
frequency of ocular therapy to a few times per year (as few as twice per
year). These technologies have solved the problems with tolerability and
blockage of vision noted with many injectable sustained release ocular
products. GrayBug is initially focused on developing its own products
for the treatment of wet AMD and glaucoma. GrayBug's technologies were
co-developed by GrayBug founder, Justin Hanes, Ph.D., who is the Lewis
J. Ort Professor of Ophthalmology at the Wilmer Eye Institute of the
Johns Hopkins University, in collaboration with GrayBug cofounders, and
leading ophthalmology clinician-scientists from the Wilmer Eye
Institute, Peter A. Campochiaro, M.D. and Peter J. McDonnell, M.D. The
technologies were licensed from Johns Hopkins University. For more
information, please visit www.graybug.com.
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 related to, among other things: the success, timing and cost
of ongoing and anticipated preclinical studies and clinical trials for
Aerie's current product candidates, including statements regarding the
timing of initiation and completion of the studies and trials;
expectations regarding the clinical effectiveness of Aerie's product
candidates and results of its clinical trials; the timing of and Aerie's
ability to obtain and maintain U.S. Food and Drug Administration or
other regulatory authority approval of, or other action with respect to,
its product candidates; expectations regarding the commercialization of
Aerie's product candidates; Aerie's plans to pursue development of its
product candidates for additional indications and other therapeutic
opportunities; Aerie's plans to explore possible uses of its existing
proprietary compounds beyond glaucoma; and expectations regarding
collaborations. 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. Many of these
risks are discussed in greater detail under the heading "Risk Factors"
in the quarterly and annual reports that Aerie files with the Securities
and Exchange Commission. In particular, 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
Eylea® is a registered mark of Regeneron Pharmaceuticals, Inc.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150805006270/en/
Richard Rubino, 908-947-3540
McClellan, Inc., on behalf of Aerie Pharmaceuticals
Jeffrey L. Cleland, Ph.D., 650-868-5853
Debra Bannister, 530-676-7373
Source: Aerie Pharmaceuticals, Inc.
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