UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
15 April 2024 - 2:00PM
Business Wire
- UroGen plans to initiate a Phase 3 study to explore the safety
and efficacy of UGN-103 in 2024
- Anticipated advantages include a new 80 mg mitomycin dosage
strength that may considerably shorten the manufacturing process,
simplify the reconstitution procedure, and potentially extend
intellectual property protection until as late as December
2041
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing novel solutions that treat
urothelial and specialty cancers, today announced the U.S. Food and
Drug Administration (FDA) accepted the Company’s Investigational
New Drug (IND) application for UGN-103, a next-generation novel
mitomycin-based formulation for low-grade intermediate-risk
non-muscle invasive bladder cancer (LG-IR-NMIBC).
The UGN-103 formulation uses UroGen’s RTGel® platform
technology, a proprietary sustained-release, reverse-thermal
hydrogel that can improve the therapeutic profiles of existing
drugs. UGN-103 is anticipated to provide several advantages related
to production, cost, supply, and product convenience if approved.
UroGen plans to initiate a Phase 3 study in 2024 to explore the
safety and efficacy of UGN-103 for the treatment of LG-IR-NMIBC, a
highly recurrent disease.
“We are delighted by the FDA's acceptance of our IND for
UGN-103, marking a significant step forward in our mission,” said
Liz Barrett, President and Chief Executive Officer of UroGen. “We
eagerly anticipate commencing a clinical trial with UGN-103 this
year, as we strive to continually advance and develop treatments
for patients with high unmet need.”
UGN-103 is planned to follow the anticipated FDA approval and
launch of UGN-102 (mitomycin) for intravesical solution for
LG-IR-NMIBC. UroGen intends to complete the rolling new drug
application (NDA) submission for UGN-102 in September 2024, with a
potential FDA decision as early as the first quarter of 2025 if
priority review is granted by FDA.
About UGN-103
UGN-103 (mitomycin) for intravesical solution is an innovative
drug formulation of mitomycin being developed for the treatment of
LG-IR-NMIBC. UroGen plans to initiate a Phase 3 study to explore
the safety and efficacy of UGN-103 in 2024. Anticipated advantages
of UGN-103 include a new 80 mg mitomycin dosage strength that may
considerably shorten the manufacturing process, simplify the
reconstitution procedure, and potentially extend intellectual
property protection until as late as December 2041. UGN-103 will
utilize UroGen’s proprietary RTGel® technology, a sustained
release, hydrogel-based formulation designed to enable longer
exposure of bladder tissue to mitomycin, thereby enabling the
treatment of tumors by non-surgical means.
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative
drug formulation of mitomycin, currently in Phase 3 development for
the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel®
technology, a sustained release, hydrogel-based formulation,
UGN-102 is designed to enable longer exposure of bladder tissue to
mitomycin, thereby enabling the treatment of tumors by non-surgical
means. UGN-102 is delivered to patients using a standard urinary
catheter in an outpatient setting. Assuming positive findings from
the durability of response endpoint from the ENVISION Phase 3
study, UroGen anticipates submitting an NDA for UGN-102 in
September 2024 and a potential FDA decision as early as the first
quarter of 2025.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and
commercializing innovative solutions that treat urothelial and
specialty cancers because patients deserve better options. UroGen
has developed RTGel® reverse-thermal hydrogel, a proprietary
sustained-release, hydrogel-based platform technology that has the
potential to improve the therapeutic profiles of existing drugs.
UroGen’s sustained release technology is designed to enable longer
exposure of the urinary tract tissue to medications, making local
therapy a potentially more effective treatment option. Our first
product to treat LG-UTUC and investigational treatment UGN-102
(mitomycin) for intravesical solution for patients with low-grade
non-muscle invasive bladder cancer are designed to ablate tumors by
non-surgical means. UroGen is headquartered in Princeton, NJ with
operations in Israel. To learn more, visit www.urogen.com or follow
us on X (Twitter), @UroGenPharma.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including, without limitation, statements regarding: the
belief that UGN-103, if approved, will provide several advantages
related to production, cost, supply, and product convenience;
UroGen’s pending intellectual property protection for UGN-103
potentially extending until December 2041; UroGen’s plans to
initiate Phase 3 studies to explore the safety and efficacy of
UGN-103 in 2024; the anticipated timing for completing a submission
of an NDA to the FDA for UGN-102 and the potential FDA decision;
and the potential of UroGen’s proprietary RTGel® technology to
improve therapeutic profiles of existing drugs and UroGen’s
sustained release technology making local delivery potentially more
effective as compared to other treatment options. Words such as
“anticipate,” “believe,” “could,” “intend,” “plan,” “potential,”
“will,” or other words that convey uncertainty of future events or
outcomes to identify these forward-looking statements. These
statements are subject to a number of risks, uncertainties and
assumptions, including, but not limited to: the anticipated
advantages of UGN-103 have not yet been demonstrated or achieved,
as applicable, and it is possible one or more of these anticipated
advantages will not be realized; preliminary results may not be
indicative of results that may be observed in the future; the
timing and success of clinical trials and potential safety and
other complications thereof; unforeseen delays that may impact the
timing of progressing clinical trials, reporting data and
initiating product launches; the ability to obtain regulatory
approval within the timeframe expected, or at all; the findings
from the durability of response endpoint from the ENVISION Phase 3
study may not be positive, and in such event, UroGen’s NDA pathway
could be negatively impacted; even if the durability of response
endpoint data from the ENVISION Phase 3 study are positive, there
is no guarantee that the current clinical development plan for
UGN-102 will ultimately support submission of an NDA; even if an
NDA for UGN-102 is accepted by the FDA, there is no guarantee that
such NDA will be sufficient to support approval of UGN-102 on the
timeframe expected, or at all; the ability to maintain regulatory
approval; the ability to obtain and maintain adequate intellectual
property rights and adequately protect and enforce such rights;
complications associated with commercialization activities; the
labeling for any approved product; competition in UroGen’s
industry; the scope, progress and expansion of developing and
commercializing UroGen’s product candidates; the size and growth of
the market(s) for UroGen’s product and product candidates and the
rate and degree of market acceptance thereof vis-à-vis alternative
therapies; UroGen’s ability to attract or retain key management,
members of the board of directors and personnel; UroGen’s RTGel
technology may not perform as expected; UroGen may not successfully
develop and receive regulatory approval of any other product that
incorporates RTGel technology; and UroGen’s financial condition and
need for additional capital in the future. In light of these risks
and uncertainties, and other risks and uncertainties that are
described in the Risk Factors section of UroGen’s Annual Report on
Form 10-K for the year ended December 31, 2023, filed with the SEC
on March 14, 2024 (which is available at http://www.sec.gov), the events and circumstances
discussed in such forward-looking statements may not occur, and
UroGen’s actual results could differ materially and adversely from
those anticipated or implied thereby. Any forward-looking
statements speak only as of the date of this press release and are
based on information available to UroGen as of the date of this
release.
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version on businesswire.com: https://www.businesswire.com/news/home/20240415706532/en/
INVESTOR CONTACT: Vincent Perrone Senior Director, Investor
Relations vincent.perrone@urogen.com 609-460-3588 ext. 1093
MEDIA CONTACT: Cindy Romano Director, Corporate Communications
cindy.romano@urogen.com 609-460-3583 ext. 1083
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