- Once issued, this patent provides U.S. intellectual property
coverage of UroGen’s RTGel® technology with medac lyophilized
mitomycin formulation, covering UGN-103 and UGN-104 development
programs until December 2041
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing innovative solutions that treat
urothelial and specialty cancers, today announced that it has
received a Notice of Allowance from the United States Patent and
Trademark Office (USPTO) for patent application no. 18/535,108
entitled “Material and Method for Treating Cancer.”
The allowed claims relate to the combination of UroGen’s RTGel®
technology with medac’s licensed proprietary lyophilized mitomycin
formulation and cover the use of UroGen’s UGN-103 and UGN-104
development programs in the treatment of low-grade
intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
and low-grade upper tract urothelial cancer (LG-UTUC),
respectively. The U.S. patent, once issued, will have an expiration
date in December 2041.
“Allowance of this patent application strengthens our
intellectual property position for our next-generation
investigational programs for patients with urothelial cancers,”
said Liz Barrett, President and CEO of UroGen. “We believe that the
combination of UroGen’s RTGel® technology with medac’s
patent-protected lyophilized mitomycin has the potential to provide
advantages related to production, cost, supply, and product
convenience for patients. Our vision remains to develop innovative
medicines that advance the care of patients, and this patent
allowance is a key element of our strategy to build a long-term
growth company.”
In January 2024, UroGen entered into a licensing and supply
agreement with medac to develop UGN-103 for LG-IR-NMIBC and UGN-104
for LG-UTUC. In April 2024, the FDA accepted UroGen’s IND
application for UGN-103 and the company is currently onboarding
clinical sites for the study. The company anticipates commencing a
similar study for UGN-104, which is expected in early 2025.
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 by a
trained healthcare professional. UroGen completed the NDA
submission for UGN-102 in August 2024, ahead of schedule. UroGen
anticipates potential FDA approval in early 2025 if the NDA is
accepted for filing by the FDA and priority review is granted.
About UGN-103 and UGN-104
UGN-103 and UGN-104 are innovative mitomycin formulations in
development by UroGen for the treatment of LG-IR-NMIBC and LG-UTUC,
respectively. UGN-103 aims to streamline manufacturing and
reconstitution processes while providing intellectual property
coverage until December 2041; it utilizes UroGen’s RTGel®
technology for prolonged mitomycin exposure. UGN-104, also
leveraging RTGel® technology, is designed for treating low-grade
upper tract urothelial cancer and is anticipated to enter Phase 3
trials in early 2025, offering a non-surgical treatment option with
similar intellectual property protection.
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.
About medac
At medac group, we believe that health is humanity’s most
valuable resource. Since 1970, our mission has been to improve
patients’ quality of life worldwide by making the best medical
treatments available. As a globally operating pharmaceutical
company headquartered in Germany, we provide high-quality medical
treatments for patients worldwide in 91 countries. With more than
2.000 employees we are committed to improving human health.
Our products are manufactured in Germany and other European
countries to the highest standards, utilizing our own logistics
center and production sites, and subsequently distributed
worldwide.
We are constantly working to improve authorized medicines and to
develop innovative therapies in the fields of rheumatology,
urology, hematology, and oncology. Part of our mission is to
provide safe, high-quality and innovative original products, as
well as generics and biosimilars. In this way, we make vital
treatments accessible to those affected.
Further information on the company can be found online at
www.medac-group.com.
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:
anticipated intellectual property protection; the potential for
UGN-103 and UGN-104 to combine UroGen’s RTGel® technology with
medac’s proprietary formulation to introduce new non-surgical
treatment options for LG-IR-NMIBC and LG-UTUC, respectively; the
belief that the combination of UroGen’s RTGel® technology with
medac’s proprietary formulation could provide several advantages
related to production, cost, supply, and product convenience; the
timing for the planned Phase 3 trial of UGN-103 and UGN-104 and the
potential approval of both drug candidates; the anticipated
approval of UGN-102 and the timing thereof; the potential for
UGN-102 to introduce a new non-surgical treatment option for
LG-IR-NMIBC; 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;
and other statements that are not historical fact. Words such as
“anticipate,” “believe,” “could,” “if,” “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 and UGN-104 have not yet been
demonstrated or achieved, as applicable, and it is possible one or
more of these anticipated advantages will not be realized; the
timing and success of clinical trials and potential safety and
other complications thereof; unforeseen delays that may impact the
timing of initiating and progressing clinical trials, reporting
data and initiating product launches; the ability to obtain
regulatory approval within the timeframe expected, or at all; even
if an NDA for UGN-102 is accepted for filing by the FDA, there is
no guarantee that such NDA will be given priority review or 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;
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 June
30, 2024, filed with the SEC on August 13, 2024 (which is available
at 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240916912176/en/
INVESTORS: Vincent Perrone Senior Director, Investor Relations
vincent.perrone@urogen.com 609-460-3588 ext. 1093
MEDIA: Cindy Romano Director, Corporate Communications
cindy.romano@urogen.com 609-460-3583 ext. 1083
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