UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers
17 1월 2024 - 10:00PM
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 a licensing
agreement with medac GmbH to develop a next-generation novel
mitomycin-based formulation for urothelial cancers.
UGN-103, UroGen’s RTGel® technology combined with medac’s
licensed mitomycin, is a next-generation formulation that is
planned to follow the anticipated U.S. Food and Drug Administration
approval and launch of UGN-102. UGN-103 is expected to provide
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 in
LG-IR-NMIBC.
"The strategic alliance with medac fortifies our commitment to
continuously innovate novel, non-surgical treatments for patients
with urothelial cancers, including LG-IR-NMIBC,” said Liz Barrett,
President and CEO of UroGen. "The 80 mg formulation of mitomycin
from medac is specifically designed to be mixed with our RTGel®
technology, which may provide advantages for patients looking for
non-surgical treatments for urothelial cancer. With medac's
intellectual property protection for this next-generation mitomycin
formulation lasting until June 2035 and our pending U.S. patent
applications, we foresee potential intellectual property protection
until December 2041."
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 a New Drug Application (NDA)
for UGN-102 in 2024 and an FDA decision in 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. Visit www.urogen.com to learn more or follow
us on X (Twitter), @UroGenPharma.
About medac GmbH
medac is a privately-owned German pharmaceutical company with
sites in Wedel and Tornesch. medac’s medicinal products are used
worldwide to help doctors and patients manage acute and chronic
diseases in the fields of oncology and haematology, urology, and
autoimmune diseases. medac also develops and distributes specialist
diagnostic systems. Since 1970, medac has been committed to its
approach of uniting therapeutic and diagnostic products under one
roof. Further information on the company and its products can be
found online at www.medac.de.
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
anticipated approval and launch of UGN-102; the timing for the
planned Phase 3 trial of UGN-103 and the potential approval of
UGN-103; the potential advantages of UGN-103; anticipated
intellectual property protection; the anticipated submission of an
NDA for UGN-102 and the timing thereof; the anticipated timing for
an FDA decision on the UGN-102 NDA; the potential for UGN-102 to
introduce a new non-surgical treatment option 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,”
“believe,” “could,” “expect,” “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: 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, 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 our NDA for UGN-102 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; UroGen’s pending patent applications may not be
successful and in such event the duration of our intellectual
property protection would be more limited; risks related to our and
our licensors’ ability to protect our respective patents and other
intellectual property; 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/20240117582883/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
UroGen Pharma (NASDAQ:URGN)
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UroGen Pharma (NASDAQ:URGN)
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