UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals
03 April 2024 - 2:00PM
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 that it has filed
a lawsuit in the U.S. District Court for the District of Delaware
against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc.,
and Teva Pharmaceutical Industries, Ltd., alleging infringement of
U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069
(“the ’069 patent”). Both patents are listed in the U.S. Food and
Drug Administration’s (“FDA”) Approved Drug Products with
Therapeutic Equivalence Evaluations (commonly known as the Orange
Book) for JELMYTO® (mitomycin) for pyelocalyceal solution. JELMYTO®
is indicated for the treatment of adults with low-grade, upper
tract urothelial cancer (“LG-UTUC”) and utilizes UroGen’s RTGel®
reverse-thermal hydrogel, a proprietary sustained-release,
hydrogel-based platform technology.
“UroGen pioneered a significant breakthrough and remains at the
forefront of transforming urothelial cancer treatment,” said Liz
Barrett, President and CEO, UroGen. “UroGen has full confidence in
the strength of its patents and plans to vigorously defend our
intellectual property rights.”
The lawsuit follows an Abbreviated New Drug Application filed by
Teva Pharmaceuticals, Inc., which seeks authorization from the FDA
to manufacture, use or sell a generic version of mitomycin for
pyelocalyceal solution, 40 mg/vial in the United States before the
expiry of the ’074 and ’069 patents.
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
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 (UTUC)
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 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.
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 statement contains forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements regarding: the potential
for UroGen to transform urothelial cancer treatments; the strength
of UroGen’s patents and UroGen’s plans to vigorously defend its
intellectual property rights; the patient population for UTUC; 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 and phrases such as
“anticipate,” “assume,” “believe,” “expected,” “if,” “indicate,”
“look forward to,” “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: uncertainties related to whether UroGen’s
patent-infringement lawsuit against Teva will be successful; the
ability obtain and maintain adequate intellectual property rights
and adequately protect and enforce such rights; the costs and
outcome of legal proceedings to enforce such intellectual property
rights, including the lawsuit against Teva; competition in UroGen’s
industry, including the potential approval and introduction of
generic or branded products that compete with UroGen’s product or
product candidates; the ability to maintain regulatory approval;
complications associated with commercialization activities; the
scope, progress and expansion of developing and commercializing
UroGen’s product candidates; the timing and success of clinical
trials and potential safety and other complications thereof; 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 RTGel technology may not
perform as expected; UroGen may not successfully develop and
receive regulatory approval of any other product that incorporates
RTGel technology; UroGen’s ability to attract or retain key
management, members of the board of directors and personnel; 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 are 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/20240403581964/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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