Santen Pharmaceutical Co., Ltd. (“Santen”) and Aerie
Pharmaceuticals, Inc. (NASDAQ: AERI, “Aerie”) announced that Santen
and Aerie have entered into an exclusive development and
commercialization agreement for Rhopressa® and Rocklatan® in Japan,
along with rights for several other Asian countries.
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,
ocular surface diseases and retinal diseases. Rhopressa®
(netarsudil ophthalmic solution) 0.02% and Rocklatan® (netarsudil
and latanoprost ophthalmic solution) 0.02%/0.005% are approved and
being sold in the United States by Aerie. Preparations for the
first Phase 3 study in Japan for Rhopressa® are ongoing and the
study is expected to commence before the end of 2020.
“In the treatment of glaucoma, where the number of glaucoma
patients continues to increase and unmet medical needs remain, we
are excited to see an increase in our product lineup and the
opportunity to offer patients new treatment options,” said Shigeo
Taniuchi, President and CEO of Santen. “Santen and Aerie both aim
to further contribute to the treatment of glaucoma patients through
these products, by taking advantage of Santen’s sales platform and
relationships with local ophthalmologists in Japan and other Asian
countries.”
“We are delighted to partner with Santen, which is a leading
global ophthalmology company and the largest in Japan. We believe
that Santen has unparalleled capabilities to develop and
commercialize our glaucoma products and to enhance the treatment
options for patients with glaucoma or ocular hypertension, an about
$1 billion market in Japan and East Asia. We look forward to a
successful collaboration with Santen,” said Vicente Anido, Jr.,
Ph.D., Chairman and Chief Executive Officer.
Under the terms of the agreement, Aerie will receive an upfront
payment of $50 million, and various development and sales
milestones of up to $99 million. Aerie is also eligible to receive
additional consideration in excess of 25% of the products’ net
sales, such consideration consisting of the cost of products
supplied to Santen from Aerie and a royalty for Aerie’s
intellectual property. Santen will be responsible for sales,
marketing and pricing decisions relating to the products. Santen
will also be responsible for all development and commercialization
costs and activities related to the products in the territories
covered by the agreement, however, Aerie and Santen will
collaborate for the first Phase 3 study for Rhopressa® in Japan. In
addition to customary termination rights for both parties, in the
event that patents are issued that may prevent the
commercialization of the products, Santen would have the right to
terminate the agreement and require Aerie’s repayment of a portion
of the upfront payment, all development milestone payments, and a
portion of the development expenses incurred by Santen.
About Glaucoma
Glaucoma is a disorder which causes optic nerve damage leading
to visual field loss and is a major cause of visual impairment
including decreased vision and blindness in many countries,
especially in Japan and several other Asian countries. Since
glaucomatous optic nerve damage and visual field defects are
generally progressive and irreversible, early detection and
treatment for controlling progression of damage is crucial in the
treatment of glaucoma.
About Santen
As a specialized company dedicated to ophthalmology, Santen
carries out research, development, marketing, and sales of
pharmaceuticals, over-the-counter products, and medical devices.
Santen is the market leader for prescription ophthalmic
pharmaceuticals in Japan and its products now reach patients in
over 60 countries. With scientific knowledge and organizational
capabilities nurtured over a 130-year history, Santen provides
products and services to contribute to the well-being of patients,
their loved ones and consequently to society. For more information,
please visit Santen’s website (www.santen.com).
Santen Forward-Looking
Statements
Information provided in this press release contains
forward-looking statements. The achievement of these forecasts is
subject to risk and uncertainty from various sources. Therefore,
please note that the actual results may differ significantly from
the forecasts. Business performance and financial conditions are
subject to the effects of changes in regulations made by the
governments of Japan and other nations concerning medical
insurance, drug pricing and other systems, and to fluctuations in
market variables such as interest rates and foreign exchange
rates.
About Aerie
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,
ocular surface diseases and retinal diseases. 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/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.
Aerie 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 in this release include statements
regarding our intentions, beliefs, projections, outlook, analyses
or current expectations concerning, among other things: the
duration and severity of the coronavirus disease (COVID-19)
outbreak, including the impact on our clinical and commercial
operations, demand for our products, our financial results and
condition and our global supply chains; our expectations regarding
the commercialization and manufacturing of Rhopressa®, Rocklatan®,
Rhokiinsa® and Roclanda® or any current or future product
candidates, including the timing, cost or other aspects of their
commercial launch; our commercialization, marketing, manufacturing
and supply management capabilities and strategies in and outside of
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, 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®, Rhokiinsa®, Roclanda®
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® 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; 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 license agreement with Santen, and payments related
thereto, 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®. Additionally, FDA approval of Rhopressa®
and Rocklatan® do not constitute FDA approval of our current or any
future product candidates, and there can be no assurance that we
will receive FDA approval for our current or any future product
candidates. 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/20201028005090/en/
Santen: Akiko Yoshikawa Corporate Communications Group Santen
Pharmaceutical Co., Ltd. E-mail: communication@santen.com Tel :
+81-6-4802-9360
Aerie: Media: Tad Heitmann 949-526-8747;
theitmann@aeriepharma.com Investors: Ami Bavishi 908-947-3949;
abavishi@aeriepharma.com
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