Clearside Biomedical Expands XIPERE™ License Agreement with Arctic Vision to Include Australia, New Zealand, India and ASEAN Countries
September 09 2021 - 7:05AM
Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company dedicated to developing and delivering treatments that
restore and preserve vision for people with serious back of the eye
diseases, announced today it has agreed to expand the territories
covered by its exclusive license agreement with Arctic Vision, a
China-based biotech company focused on innovative ophthalmic
therapies. As now amended, the licensed territory for XIPERE™
(triamcinolone acetonide suprachoroidal injectable suspension) has
been expanded from Greater China (mainland China, Hong Kong, Macau
and Taiwan) and South Korea to also include Australia, New Zealand,
India and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos,
Malaysia, Myanmar, the Philippines, Singapore, Thailand, and
Vietnam).
“Over the past year, we have forged a strong
relationship with Arctic Vision and have been impressed with their
team’s speed and dedication to bringing needed ophthalmic
treatments to a large and important global region,” said George
Lasezkay, Pharm.D., J.D., President and Chief Executive Officer,
Clearside Biomedical. “If approved, XIPERE will be the first
therapy for macular edema associated with uveitis and will be the
first approved therapeutic delivered into the suprachoroidal space.
We are dedicated to providing global access to our clinically
tested, non-surgical, repeatable micro-injection technology
designed to unlock the potential clinical benefits of administering
drugs into the suprachoroidal space.”
XIPERE, referred to as ARVN001 by Arctic Vision,
is a proprietary suspension of the corticosteroid triamcinolone
acetonide formulated for administration to the suprachoroidal space
(SCS®) using Clearside’s patented SCS Microinjector®. The product
candidate is being investigated for the treatment of macular edema
associated with uveitis. In the U.S., Clearside’s New Drug
Application for XIPERE is under review by the U.S. Food and Drug
Administration, with a Prescription Drug User Fee Act (PDUFA)
action date of October 30, 2021. In China, Arctic Vision is
planning to initiate a Phase 3 clinical trial of ARVN001 in the
second half of 2021.
“We are very excited to expand the licensed
territory of ARVN001 to two of the most important countries in the
Pacific region,” said Eddy (Hoi Ti) Wu, Ph.D., Founder and CEO of
Arctic Vision. “Building our commercial reach into the overseas
market has always been a major strategic goal, and this amendment
greatly accelerates the process. Beginning with ARVN001, we strive
to bring innovative eyecare solutions to the greater pan-Asia
market.”
Under the terms of the amended agreement,
Clearside will receive a total of $3.0 million in upfront payments
and is entitled to additional payments upon the achievement of
certain regulatory and sales milestones in the newly added
countries (including Australia, New Zealand, India and the ASEAN
Countries). These financial terms for the new countries are in
addition to the previously announced milestone payments for the
achievement of specified events prior to and including receipt of
approval of XIPERE in the United States and other development and
ARVN001 approval and sales-based events in the original territory
of Greater China and South Korea. Clearside is entitled to receive
tiered royalties of 10% to 12% based on annual net sales of ARVN001
in all territories covered by the amended agreement.
Clearside is also partnered with an affiliate of
Bausch Health, which holds the exclusive license for the
commercialization and development of XIPERE in the United States
and Canada. Clearside is currently in discussions with other
potential partners regarding licensing the rights to commercialize
and develop XIPERE in the European Union, the United Kingdom, South
America and Mexico.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing and delivering
treatments that restore and preserve vision for people with serious
back of the eye diseases. Clearside’s proprietary SCS
Microinjector® targets the suprachoroidal space (SCS®) and offers
unique access to the macula, retina and choroid where
sight-threatening disease often occurs. The Company’s SCS injection
platform is an inherently flexible, in-office, non-surgical
procedure, intended to provide targeted delivery to the site of
disease and to work with both established and new formulations of
medications. For more information, please visit
clearsidebio.com.
Cautionary Note Regarding
Forward-Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe”, “expect”, “may”, “plan”,
“potential”, “will”, and similar expressions, and are based on
Clearside’s current beliefs and expectations. These forward-looking
statements include statements regarding the potential approval of
XIPERE by the FDA, the commercial potential of XIPERE and Arctic
Vision’s clinical development of ARVN001 and potential launch in
the licensed territories. These statements involve risks and
uncertainties that could cause actual results to differ materially
from those reflected in such statements. Risks and uncertainties
that may cause actual results to differ materially include
uncertainties inherent in the conduct of clinical trials,
Clearside’s reliance on third parties over which it may not always
have full control, uncertainties regarding the COVID-19 pandemic
and other risks and uncertainties that are described in Clearside’s
Annual Report on Form 10-K for the year ended December 31, 2020,
filed with the U.S. Securities and Exchange Commission (SEC) on
March 15, 2021, and Clearside’s other Periodic Reports filed with
the SEC. Any forward-looking statements speak only as of the date
of this press release and are based on information available to
Clearside as of the date of this release, and Clearside assumes no
obligation to, and does not intend to, update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor and Media Contacts:Jenny Kobin Remy
Bernarda ir@clearsidebio.com(678) 430-8206
Source: Clearside Biomedical, Inc.
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