Ocugen licenses OCU400 to Kwangdong for $7.5 million, with potential sales milestones of $180 million and 25% royalties.
Quiver AI Summary
Ocugen, Inc. has entered into a licensing agreement with Kwangdong Pharmaceutical, granting exclusive rights to OCU400, a gene therapy for retinitis pigmentosa (RP) in Korea. This agreement includes up to $7.5 million in upfront fees and milestone payments, with potential sales milestones of $180 million over the first decade of commercialization, and a royalty of 25% on net sales. Ocugen will also be responsible for manufacturing the therapy. Kwangdong aims to expedite the regulatory process using Ocugen's clinical data, enhancing its position in ophthalmic gene therapy. The partnership is significant for addressing the needs of an estimated 7,000 RP patients in Korea, and both companies are optimistic about bringing this innovative treatment to market following regulatory approval.
Potential Positives
- Ocugen secured a licensing agreement with Kwangdong Pharmaceutical, granting exclusive rights to OCU400 in Korea, potentially expanding their market presence.
- The agreement includes upfront fees and development milestone payments totaling up to $7.5 million, providing immediate funding for Ocugen.
- Projected sales milestones of $180 million or more in the first 10 years of commercialization indicate significant revenue potential from the partnership.
- Ocugen will receive a 25% royalty on net sales of OCU400, ensuring ongoing revenue from the product's success in the Korean market.
Potential Negatives
- There is significant uncertainty about the success of the licensing agreement with Kwangdong, as the press release includes numerous forward-looking statements about expectations that may not materialize.
- The potential sales milestones and royalties depend heavily on future performance and regulatory approvals, which introduces risk concerning the actual financial benefits to Ocugen.
- There is a notable risk that clinical trial data may not support the anticipated efficacy of OCU400, which could affect commercialization and sales outcomes significantly.
FAQ
What is the licensing agreement between Ocugen and Kwangdong Pharmaceutical?
Ocugen has licensed the exclusive rights to OCU400 in Korea to Kwangdong Pharmaceutical, including upfront fees and milestone payments.
How much is Ocugen expected to earn from this agreement?
Ocugen could earn up to $7.5 million in upfront fees and development milestones, plus potential sales milestones of $180 million in the first 10 years.
What is OCU400 and its significance?
OCU400 is a novel gene therapy for retinitis pigmentosa, offering a potential one-time treatment option for patients facing vision loss.
When is the U.S. BLA filing for OCU400 planned?
Ocugen aims to file the U.S. Biologics License Application for OCU400 in 2026.
What are the expected royalties from OCU400's sales?
Ocugen will receive a royalty of 25% on net sales of OCU400 generated by Kwangdong in Korea.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
- Upfront fees and near-term development milestone payments totaling up to $7.5 million
- Potential sales milestones of $180 million or more in first 10 years of commercialization
- Royalties equaling 25% of net sales
- Ocugen to manufacture and supply OCU400
MALVERN, Pa., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today executed a licensing agreement with Kwangdong Pharmaceutical, Co., Ltd., (“Kwangdong”) one of the leading pharmaceutical companies in Korea, for the exclusive Korean rights to OCU400—Ocugen’s novel modifier gene therapy for retinitis pigmentosa (RP).
Pursuant to the License Agreement, Ocugen will receive upfront license fees and near-term development milestones equaling up to $7.5 million. The Company will be entitled to sales milestones of $1.5 million for every $15 million of sales in Korea, projected to reach $180 million or more in the first 10 years of commercialization. Additionally, Ocugen will receive a royalty of 25% on net sales of OCU400 generated by Kwangdong. Ocugen will manufacture the commercial supply of OCU400 under terms of a supply agreement.
There are an estimated 7,000 individuals in the Republic of Korea with RP, which represents approximately 7% of the U.S. market. OCU400 provides the opportunity for our partner to help thousands of patients facing vision loss. Upon regulatory approval of OCU400 in Korea, we believe Kwangdong will become a leader in the field of ophthalmic gene therapy in Korea.
“We are excited to partner with Kwangdong as our first regional partner in the development and commercialization of our modifier gene therapies across the globe,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “OCU400 is a potential one-time therapy for life to treat RP and upon local regulatory approval, patients in Korea with this devastating condition will be able to access OCU400 through Kwangdong.”
Kwangdong, a top five pharmaceutical and healthcare company in Korea, has a diverse portfolio of products including prescription pharmaceuticals and over-the-counter healthcare products. The company is actively involved in research and development innovation including transformational late-stage, high-impact technologies.
“Kwangdong is very excited to have the opportunity to provide a new treatment option to Korean patients suffering from RP and the healthcare professionals treating them,” said SungWon Choi, CEO & Chairman of Kwangdong. “From the company’s perspective, this deal with Ocugen is especially meaningful as it allows us to further strengthen our ophthalmology portfolio, alongside our existing pipeline for presbyopia and pediatric myopia. Once the ongoing clinical trial of OCU400 is completed, Kwangdong will make every effort to bring the product to the Korean market as quickly as possible.”
Ocugen is currently advancing OCU400 through Phase 3 clinical development with a target U.S. Biologics License Application (BLA) filing in 2026.
Kwangdong intends to utilize Ocugen’s clinical data and BLA filing as part of their regulatory submission for approval in Korea.
About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at
www.ocugen.com
and follow us on
X
and
LinkedIn
.
About Kwangdong Pharmaceutical Co., Ltd
Kwangdong Pharmaceutical Co., Ltd is a South Korean human healthcare company founded in 1963. The company focuses on the development, manufacture, and sale of pharmaceutical products, as well as health drinks and functional foods. The company's business is segmented into Pharmacy Sales, Hospital Sales, Distribution Sales, and Water Sales, each focusing on different aspects of the healthcare market. Kwangdong Pharmaceutical's vision is to become a leading human healthcare brand company with a strong focus on innovation, research, and development. Kwangdong is consistently ranked as one of the top 10 pharmaceutical and healthcare companies in Korea by multiple metrics.
Cautionary Note on Forward-Looking Statements
This
press
release
contains
forward-looking
statements
within
the
meaning
of
The
Private
Securities
Litigation
Reform
Act
of
1995,
including,
but
not limited to, statements regarding the anticipated benefits to Ocugen of the definitive license agreement, qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,
which
are
subject
to
risks
and
uncertainties.
We
may,
in
some
cases,
use
terms
such
as
“predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,”
or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including,
but
not
limited
to,
the risks that the license agreement with Kwangdong will not lead to the current anticipated benefits to Ocugen, including projected sales royalties and milestones,
the
risks
that
preliminary,
interim
and
top-line
clinical
trial
results
may
not
be
indicative
of,
and
may
differ
from,
final
clinical data;
the ability of OCU400 to perform in humans in a manner consistent with nonclinical or preclinical study data;
that
unfavorable
new
clinical
trial
data
may
emerge
in
ongoing
clinical
trials
or
through
further
analyses
of
existing
clinical
trial
data;
that
earlier non-clinical
and
clinical
data
and
testing
of
may
not
be
predictive
of
the
results
or
success
of
later
clinical
trials;
and
that
that
clinical
trial
data
are subject to differing interpretations and assessments, including by regulatory authorities.
These
and
other
risks
and
uncertainties
are
more
fully described
in
our
periodic
filings
with
the
Securities
and
Exchange
Commission
(“SEC”),
including
the
risk
factors
described
in
the
section
entitled
“Risk Factors”
in
the
quarterly
and
annual
reports
that
we
file
with
the
SEC.
Any
forward-looking
statements
that
we
make
in
this
press
release
speak
only
as of
the
date
of
this
press
release.
Except
as
required
by
law,
we
assume
no
obligation
to
update
forward-looking
statements
contained
in
this
press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Contact:
Tiffany Hamilton
AVP, Head of Communications
[email protected]
