UroGen Initiates Submission of a Rolling NDA to the FDA for UGN-102
24 Janeiro 2024 - 10:00AM
Business Wire
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing novel solutions that treat
urothelial and specialty cancers, today announced the submission of
the Chemistry, Manufacturing, and Controls (CMC) section of the New
Drug Application (NDA) for UGN-102 (mitomycin) for intravesical
solution to the U.S. Food and Drug Administration (FDA).
"The submission of the CMC portion of the NDA for UGN-102 marks
a significant milestone for UroGen and underscores our dedication
to advancing innovative therapies for the benefit of individuals
grappling with low-grade, intermediate-risk non-muscle invasive
bladder cancer,” said Liz Barrett, President and CEO, UroGen. “We
look forward to working closely with the FDA throughout the review
process and remain steadfast in our commitment to address unmet
medical needs in the uro-oncology space and advance patient
care."
The objective of the rolling NDA for UGN-102 is to facilitate
early engagement with the FDA, and a more efficient and timely
review of the NDA. Based on its agreement with the FDA, UroGen will
complete the submission of the rolling NDA for UGN-102 in 2024 with
a potential FDA decision as early as the first quarter of 2025.
The CMC section of a regulatory submission typically includes
information about the drug product such as its physicochemical
properties, formulation, methods of manufacture, specifications,
stability data, and analytical methods used to test the
product.
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 low-grade, intermediate-risk, non-muscle invasive
bladder cancer (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 completing its NDA submission for UGN-102
in 2024 with 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 low-grade upper tract urothelial cancer 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. Visit
www.urogen.com to learn more 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
planned completion of the NDA submission for UGN-102 and the timing
thereof; the timing for an FDA decision on UGN-102; the potential
for UGN-102 to introduce a new non-surgical treatment paradigm for
LG-IR-NMIBC 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,” “assume,” “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: 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 and reporting data; 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, our 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, notwithstanding the current agreement with
the FDA; 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; 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 our 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 Quarterly Report on Form
10-Q for the quarter ended September 30, 2023, filed with the SEC
on November 14, 2023 (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/20240124917135/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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