UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing novel solutions that treat
urothelial and specialty cancers, today announced that David Lin
will join UroGen as its Chief Commercial Officer and member of the
Executive Leadership Team. In this role, David will be spearheading
UroGen’s commercial strategy, including preparation for the
potential launch of our lead pipeline candidate UGN-102, if
approved, and driving the continued growth and commercialization of
JELMYTO® (mitomycin) for pyelocalyceal solution.
David Lin brings to UroGen a wealth of experience garnered from
a distinguished career in the pharmaceutical industry. Prior to
joining UroGen, David held several key leadership positions at
Bristol Myers Squibb, where he played pivotal roles in driving the
success of various initiatives. Notably, as Head of U.S. Cell
Therapy, David led the successful launch of two CAR T therapies,
showcasing his expertise in bringing innovative therapies to
market. Additionally, his tenure as Head of Worldwide
Cardiovascular contributed significantly to the global
cardiovascular franchise, including expansion through the MyoKardia
acquisition.
"As we enter the next stage in building a long-term growth
company, we are thrilled to welcome David to the UroGen team," said
Liz Barrett, President and CEO of UroGen Pharma. "His extensive
experience and proven track record of commercial success will be
invaluable as we advance our mission of bringing innovative
therapies to patients in need. With David's leadership, we are
confident in our ability to maximize the commercial potential of
JELMYTO and our expanding pipeline."
Before his time at Bristol Myers Squibb, David served as Global
Head of Surgery and Perioperative Care at The Medicines Company,
demonstrating his diverse experience across different sectors of
the healthcare industry. His career journey also includes various
leadership roles at Johnson & Johnson, where he made impactful
contributions to pharmaceuticals, medical devices, and consumer
businesses.
David Lin expressed his enthusiasm about joining UroGen,
stating, "I am honored to join UroGen at such an exciting time in
the company's evolution. I look forward to working closely with the
team to drive commercial success and ultimately make a meaningful
difference in the lives of patients with urothelial cancers."
David is an alumnus of Cornell University, where he earned his
Bachelor of Arts in Economics, and Duke University, where he
completed his Master of Business Administration (MBA). Beyond his
professional endeavors, David is actively engaged in mentoring
start-up businesses in life sciences as a member of the Canadian
Technology Accelerator and serves as a Strategic Advisor to
ChroniSense Medical, a clinical-stage medical technology
company.
Jeff Bova will be stepping down as Chief Commercial Officer on
June 3 as he pursues new opportunities. We are incredibly grateful
for the work he did here at UroGen.
For more information about UroGen Pharma and its portfolio of
urological solutions, please visit www.urogen.com.
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-UTUC (LG-UTUC). It is approved for adult patients with
LG-UTUC. 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 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. 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 Q3 2024 with a potential U.S. Food and Drug
Administration (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 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.
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
1800FDA1088. 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
potential approval and launch of UGN-102; expected contributions of
executive leadership team members and UroGen’s ability to maximize
the commercial potential of JELMYTO and its expanding pipeline; the
potential benefits of UGN-102; UroGen’s ongoing clinical trials,
including the ENVISION Phase 3 study; UroGen’s plans to submit an
NDA to the FDA for UGN-102 and the expected timing thereof and the
timing for potential FDA decisions thereon; 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. These statements are subject
to a number of risks, uncertainties and assumptions, including, but
not limited to: results from completed clinical trials may not be
indicative of results that may be observed in the future; there is
no guarantee that the current clinical development plan for UGN-102
will ultimately support the 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; potential safety and other
complications from UGN-102; 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 ability to maintain regulatory approval;
the ability to obtain and maintain adequate intellectual property
rights and adequately protect and enforce such rights;
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 the
growth of the market(s) for UroGen’s product and product
candidates, the rate and degree of market acceptance thereof
vis-à-vis alternative therapies; UroGen’s ability to attract or
retain key management, members of its board of directors and
personnel; UroGen’s RTGel technology may not perform as expected;
and UroGen may not successfully develop and receive regulatory
approval of any other product that incorporates UroGen’s RTGel
technology. 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 March 31, 2024, filed with the SEC on May 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/20240603331264/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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