Aerie Pharmaceuticals, Inc. and DSM Biomedical, Inc. Expand Collaboration Agreement Focused on Novel Drug Delivery Technology in Ophthalmology
Business Wire 1-Aug-2018 6:30 AM
Promising Technology Platform to Potentially Deliver Therapies to
Treat a Broad Spectrum of Ophthalmic Diseases
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, and DSM
Biomedical, Inc., a global solutions provider in biomedical science and
regenerative medicine, today reported that they have expanded their
collaborative research, development, and license agreement.
In July 2017, Aerie announced that it had entered into a research
collaboration and license option agreement with DSM for purposes of
evaluating the sustained delivery of certain Aerie compounds using DSM's
bioerodible polyesteramide polymer technology. The initial focus has
been on retinal diseases such as wet AMD (wet age-related macular
degeneration) and DME (diabetic macular edema). Promising preclinical
results have been obtained with polyesteramide-based implants containing
AR-13503, an Aerie-owned preclinical small molecule, and Aerie expects
to file an IND (Investigational New Drug) application in early 2019.
AR-13503 inhibits Rho kinase and Protein kinase C and thus has the
potential to address vascular dysfunction, fibrosis and inflammation in
retinal diseases. When formulated as a sustained-release implant using
DSM's bioerodible polyesteramide polymer technology, AR-13503 may reduce
treatment burden by allowing for intravitreal injection approximately
every six months. In preclinical models of wet AMD and proliferative
diabetic retinopathy, this molecule has shown a reduction of lesion size
at levels consistent with the market-leading anti-VEGF product
containing aflibercept. Additionally, when used additively to
aflibercept, further improvements in lesion size reduction have been
observed. Pending additional studies, AR-13503 and related compounds may
have the potential to provide an entirely new mechanism of action to
treat these diseases.
The expanded agreement with DSM provides for the following:
-
Aerie will immediately have a worldwide exclusive license for all
ophthalmic indications to DSM's polyesteramide polymer technology for
an unlimited number of compounds.
-
Aerie and DSM will continue collaborative research activities through
the end of 2020, including the transfer of DSM's formulation
technology to Aerie during that time.
-
Aerie will gain access to DSM's preclinical stage latanoprost implant
with the potential for initial clinical studies in glaucoma patients
in 2019. This implant may potentially be inserted via subconjunctival
or intracameral injection, utilizing Aerie's PRINT®
technology license to allow Aerie to manufacture these implants.
Aerie paid $6.0 million to DSM upon signing of the expanded agreement,
with an additional $9.0 million payable to DSM through the end of 2020.
Further payments to DSM are contingent upon Aerie's achievement of
various clinical and regulatory development milestones, and if products
are commercialized under this collaborative agreement, Aerie would also
pay royalties to DSM.
"This expanded agreement with DSM opens up many new opportunities to
Aerie as we continue to innovate with new drugs and technologies to
potentially treat many diseases of the eye, far beyond our current
priority of moving AR-13503 into the clinic next year. For Aerie, this
is a platform upon which we can build our innovative sustained release
strategies for many ophthalmic diseases, including glaucoma,"
said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at
Aerie.
"We are very excited that we have expanded our partnership with
Aerie, a company that is widely recognized as a leading company in the
development of new ophthalmology medicines that have the potential to
brighten the lives of many patients," said Marc Hendriks, Ph.D.,
Head of Strategy & Alliances at DSM Biomedical. "Moreover, it is a
validation of the enabling value our bioerodible polyesteramide polymer
brings in the development of innovative sustained release products; a
platform technology that we can extend to other disease areas."
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.
DSM – Bright Science. Brighter Living.™
Royal DSM is a purpose-led global science-based company in Nutrition,
Health and Sustainable Living. DSM is driving economic prosperity,
environmental progress and social advances to create sustainable value
for all stakeholders. DSM delivers innovative business solutions for
human nutrition, animal nutrition, personal care and aroma, medical
devices, green products and applications, and new mobility and
connectivity. DSM and its associated companies deliver annual net sales
of about €10 billion with approximately 23,000 employees. The company is
listed on Euronext Amsterdam. More information can be found at www.dsm.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", "opportunities" 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 of any development efforts growing out of Aerie's collaboration
with DSM for the treatment of macular degeneration or other ophthalmic
uses, the likelihood that any such development efforts will result in
product approval by the FDA or other Regulatory Agencies, our
expectations regarding the commercial launch and sales of Rhopressa®
and RoclatanTM 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 RoclatanTM and any
future product candidates, if approved; the glaucoma patient market size
and the rate and degree of market adoption of Rhopressa® and
RoclatanTM 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 RoclatanTM
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 RoclatanTM 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®, RoclatanTM
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®,
RoclatanTM 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®, RoclatanTM and any
future product candidates; the potential advantages of Rhopressa®,
RoclatanTM and any future product candidates; our plans
to pursue development of additional product candidates and technologies
in ophthalmology, including development of Rhopressa® and
RoclatanTM 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
RoclatanTM, and there can be no assurance that we will
receive FDA approval for RoclatanTM or for 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. 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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