NEW YORK--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, today announced that it has initiated the rolling submission with the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) for UGN-101 (mitomycin gel) for instillation as a treatment for patients with low-grade upper tract urothelial cancer (LG UTUC). The company expects to complete its NDA submission by mid-2019, with potential approval in 2019.
“This is an important milestone in our mission to bring innovative, non-surgical treatment options to patients with urothelial cancers and potentially eliminate the need for repetitive surgical intervention and kidney removal,” said Ron Bentsur, Chief Executive Officer of UroGen. “UGN-101 has the potential to be the first non-surgical therapy for LG UTUC, and the first drug ever approved in this indication. We are grateful to our UroGen team and clinical investigators who have worked diligently to advance this potentially paradigm-shifting program.”
The NDA submission is supported by clinical data from the Phase 3 OLYMPUS clinical trial of UGN-101 for the non-surgical treatment of LG UTUC. Results from an interim analysis were presented at the American Urologic Association Annual Meeting in May 2018. UroGen plans to present topline data from the OLYMPUS study in January 2019.
The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.
About UGN-101
UGN-101 (mitomycin gel) for instillation is an
investigational drug formulation of mitomycin in Phase 3 development for
the treatment of low-grade upper tract urothelial cancer (LG UTUC).
Utilizing the RTGel™ technology platform, UroGen’s proprietary sustained
release, hydrogel-based formulation, UGN-101 is designed to enable
longer exposure of mitomycin to urinary tract tissue, thereby enabling
the treatment of tumors by non-surgical means. UGN-101 is delivered to
patients using standard ureteral catheters.
About UroGen Pharma Ltd.
UroGen Pharma Ltd. (Nasdaq:URGN) is
a clinical-stage biopharmaceutical company developing advanced
non-surgical treatments to address unmet needs in the field of urology,
with a focus on uro-oncology. UroGen has developed RTGel™, a proprietary
sustained release, hydrogel-based platform technology that has the
potential to improve 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. UroGen’s lead product
candidates, UGN-101 and UGN-102, are designed to potentially remove
tumors by non-surgical means and to treat several forms of non-muscle
invasive urothelial cancer, including low-grade upper tract urothelial
carcinoma and bladder cancer, respectively. UroGen is headquartered in
New York, NY with operations in Los Angeles, CA and Israel.
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 with respect to the
timing of the completion of UroGen Pharma’s NDA submission, the timing
of top line results for the Olympus pivotal Phase 3 trial, and the
potential of UGN-101 to be the first non-surgical therapy for LG UTUC
and the first drug ever approved in this indication, which statements
are subject to a number of risks, uncertainties and assumptions,
including, but not limited to: the timing and success of clinical
trials, including the Olympus pivotal Phase 3 trial, and potential
safety and other complications thereof; the ability to obtain and
maintain regulatory approval; the labeling for any approved product; the
scope, progress and expansion of developing and commercializing UroGen
Pharma’s product candidates; the size and growth of the market(s)
therefor and the rate and degree of market acceptance thereof vis-à-vis
alternative therapies; and UroGen Pharma’s ability to attract or retain
key management, members of the board of directors and personnel. In
light of these risks and uncertainties, and other risks and
uncertainties that are described in the Risk Factors section of UroGen
Pharma’s Form 20-F filed with the SEC on March 15, 2018 and other
filings that UroGen Pharma makes with the SEC from time to time (which
are available at http://www.sec.gov),
the events and circumstances discussed in such forward-looking
statements may not occur, and UroGen Pharma’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
Pharma as of the date of this release.