- Subgroup analysis of the UGN-102 ATLAS Trial in patients with
new versus recurrent low-grade intermediate-risk non-muscle
invasive bladder cancer (LG-IR-NMIBC)
- Three independent long-term real-world analyses of JELMYTO®
(mitomycin) for pyelocalyceal solution exploring its use in broad
patient types and method of administration
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing innovative solutions that treat
urothelial and specialty cancers, today announced that new data on
investigational drug UGN-102 (mitomycin) and JELMYTO and will be
presented at the American Urological Association (AUA) 2024 Annual
Meeting being held in San Antonio, Texas from May 3 – 6.
“We are proud that the AUA selected the ATLAS post-hoc analysis
as a podium presentation,” said Mark Schoenberg, M.D., Chief
Medical Officer, UroGen. “The results highlight UGN-102’s potential
to help significantly advance treatment for patients with newly
diagnosed and recurrent LG-IR-NMIBC, a highly prevalent and
recurrent disease. Additionally, we are excited to see additional
independent real-world evidence related to JELMYTO treatment of
LG-UTUC patients in a diverse patient types.”
Key details of UGN-102 and JELMYTO abstracts accepted by
AUA:
Abstract Title
Presentation Details
Response to Primary Chemoablation with
UGN-102 in Patients with New or Recurrent LG IR NMIBC: Post-hoc
Analysis of the ATLAS Trial
Podium Oral Presentation: Abstract ID
24-6641, Saturday, May 4, 2:20-2:30 PM CDT, Location 304A
Presenter: Dr. William Huang
Longitudinal Follow Up of Multicenter
Study of UGN-101 for Upper Tract Urothelial Cancer
Podium Oral Presentation: Abstract ID
24-7470, Sunday, May 5, 11:10-11:20 AM CDT, Location 301A
Presenter: Dr. Yair Lotan
Exploring Recurrence After Initial
Response to UGN-101 Induction in Expanded Settings
Podium Oral Presentation:
Abstract ID 24-7534, Sunday May 5,
11:20-11:30 AM CDT, Location 301A
Presenter: Dr. Adam Feldman
Mitomycin-containing Reverse Thermal
Gel UGN-101 for Upper Tract Urothelial Carcinoma: Retrograde
Instillation in Clinic and Outcomes
Video Presentation:
Abstract ID 24-7720, Saturday, May 4,
10:50-11:00 AM CDT, Location Video Abstract Theater
Presenter: Dr. Golena Moncaleano
UroGen Sponsors AUA Innovation Nexus
UroGen’s President and Chief Executive Officer, Liz Barrett,
will participate in a panel discussion about the state of
innovation in urology and a reverse pitch on key areas of discovery
and collaboration during the AUA Innovation Nexus Conference on May
2. The AUA Innovation Nexus is a powerful forum to advance urologic
discovery to solutions that improve patient care and save lives.
Register here:
https://auanexus.org/innovation-nexus-conference/registration
State of Innovation in Urology
Reverse Pitch: 1-2 PM CDT
Showcase Panel: Thursday May 2
between 2:45-4:45 PM CDT
Liz Barrett, President and CEO, UroGen
Pharma & Other Speakers
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 completing its new drug application (NDA)
submission for UGN-102 in September 2024 with a potential FDA
decision as early as the first quarter of 2025.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
In the U.S. bladder cancer is the second most common urologic
cancer in men. LG-IR-NMIBC represents approximately 22,000 newly
diagnosed bladder cancer patients each year and an estimated
existing 60,000 recurrent patients. Bladder cancer primarily
affects older populations with the median age of diagnosis 73 years
and an increased risk of comorbidities. Guideline recommendations
for managing LG-IR-NMIBC include transurethral resection of bladder
tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC
patients experience at least one recurrence and LG-IR-NMIBC
patients are even more likely to recur and face repeat TURBT
procedures.
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a
mitomycin-containing reverse thermal gel containing 4 mg mitomycin
per mL gel indicated for the treatment of adult patients with
low-grade upper tract urothelial cancer (LG-UTUC). It is
recommended for primary treatment of biopsy-proven LG-UTUC in
patients deemed appropriate candidates for renal-sparing therapy.
JELMYTO is a viscous liquid when cooled and becomes a semi-solid
gel at body temperature. The drug slowly dissolves over four to six
hours after instillation and is removed from the urinary tract by
normal urine flow and voiding. It is approved for administration in
a retrograde manner via ureteral catheter or antegrade through
nephrostomy tube. The delivery system allows the initial liquid to
coat and conform to the upper urinary tract anatomy. The eventual
semisolid gel allows for chemoablative therapy to remain in the
collecting system for four to six hours without immediately being
diluted or washed away by urine flow.
About Upper Tract Urothelial Cancer
Urothelial cancer is the ninth most common cancer globally and
the eighth most lethal neoplasm in men in the U.S. Between five
percent and ten percent of primary urothelial cancers originate in
the ureter or renal pelvis and are collectively referred to as
upper tract urothelial cancers (UTUC). In the U.S., there are
approximately 6,000 - 7,000 new or recurrent low-grade UTUC
patients annually. Most cases are diagnosed in patients over 70
years old, and these older patients often face comorbidities. There
are limited treatment options for UTUC, with the most common being
endoscopic surgery or nephroureterectomy (removal of the entire
kidney and ureter). These treatments can lead to a high rate of
recurrence and relapse.
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.
APPROVED USE FOR JELMYTO
JELMYTO® is a prescription medicine used to treat adults with a
type of cancer of the lining of the upper urinary tract including
the kidney called low-grade Upper Tract Urothelial Cancer
(LG-UTUC).
IMPORTANT SAFETY INFORMATION
You should not receive JELMYTO if you have a hole or tear
(perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about
all your medical conditions, including if you:
- are pregnant or plan to become pregnant. JELMYTO can harm your
unborn baby. You should not become pregnant during treatment with
JELMYTO. Tell your healthcare provider right away if you become
pregnant or think you may be pregnant during treatment with
JELMYTO. Females who are able to become pregnant: You should
use effective birth control (contraception) during treatment with
JELMYTO and for 6 months after the last dose. Males being
treated with JELMYTO: If you have a female partner who is able
to become pregnant, you should use effective birth control
(contraception) during treatment with JELMYTO and for 3 months
after the last dose.
- are breastfeeding or plan to breastfeed. It is not known if
JELMYTO passes into your breast milk. Do not breastfeed during
treatment with JELMYTO and for 1 week after the last dose.
- Tell your healthcare provider if you take water pills
(diuretic).
How will I receive JELMYTO?
- Your healthcare provider will tell you to take a medicine
called sodium bicarbonate before each JELMYTO treatment.
- You will receive your JELMYTO dose from your healthcare
provider 1 time a week for 6 weeks. It is important that you
receive all 6 doses of JELMYTO according to your healthcare
provider’s instructions. If you miss any appointments, call your
healthcare provider as soon as possible to reschedule your
appointment. Your healthcare provider may recommend up to an
additional 11 monthly doses.
- JELMYTO is given to your kidney through a tube called a
catheter.
- During treatment with JELMYTO, your healthcare provider may
tell you to take additional medicines or change how you take your
current medicines.
After receiving JELMYTO:
- JELMYTO may cause your urine color to change to a violet to
blue color. Avoid contact between your skin and urine for at least
6 hours.
- To urinate, males and females should sit on a toilet and
flush the toilet several times after you use it. After going to the
bathroom, wash your hands, your inner thighs, and genital area well
with soap and water.
- Clothing that comes in contact with urine should be washed
right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:
- Swelling and narrowing of the tube that carries urine from
the kidney to the bladder (ureteric obstruction). If you
develop swelling and narrowing, and to protect your kidney from
damage, your healthcare provider may recommend the placement of a
small plastic tube (stent) in the ureter to help the kidney drain.
Tell your healthcare provider right away if you develop side pain
or fever during treatment with JELMYTO.
- Bone marrow problems. JELMYTO can affect your bone
marrow and can cause a decrease in your white blood cell, red blood
cell, and platelet counts. Your healthcare provider will do blood
tests prior to each treatment to check your blood cell counts
during treatment with JELMYTO. Your healthcare provider may need to
temporarily or permanently stop JELMYTO if you develop bone marrow
problems during treatment with JELMYTO.
- The most common side effects of JELMYTO include: urinary
tract infection, blood in your urine, side pain, nausea, trouble
with urination, kidney problems, vomiting, tiredness, stomach
(abdomen) pain.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1‑800‑FDA‑1088. You may also report side effects to UroGen
Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including
the Patient Information, for additional information.
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 submission of an NDA to the FDA for UGN-102 and the
timing thereof; the anticipated timing for an FDA decision; the
potential of UroGen’s proprietary RTGel technology to improve
therapeutic profiles of existing drugs; and the potential of
UroGen’s sustained release technology to make local delivery more
effective as compared to other treatment options. Words such as
“anticipate,” “assume,” “could,” “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 and reporting data; 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 obtain regulatory
approval within the timeframe expected, or at all; the ability to
obtain and maintain adequate intellectual property rights and
adequately protect and enforce such rights; 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 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 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/20240417923260/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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