Israel's UroGen to start
mid-stage bladder cancer trial
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[June 21, 2018] By
Tova Cohen
RAANANA, Israel (Reuters) - Israel's UroGen
Pharma plans to begin a mid-stage trial of its treatment for bladder
cancer patients in August, after positive interim results last month
from an advanced trial of a treatment for upper urinary tract cancer.
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UroGen's shares have more than tripled in the past year. In May, it
reported 59 percent of patients with upper tract urothelial
carcinoma (UTUC) went into full remission in a phase three trial of
its MitoGel treatment.
The company will have final results from that trial in the second
half of 2018 and plans to file for approval by the U.S. Food and
Drug Administration in early 2019.
"We expect a six-month review ... which means that the drug could be
launched in the fourth quarter of 2019," CEO Ron Bentsur told
Reuters.
About 15,000 people in the United States suffer from UTUC and
Bentsur estimates this market for UroGen at $350-$500 million
annually. Bladder cancer, with about 350,000 U.S. patients, would be
much bigger.

The Phase 2b trial for VesiGel to treat non-muscle invasive bladder
cancer will take 12-18 months and focus on patients who don't
respond well to the standard tumor surgical procedure.
"We believe this approach ... could give us a much faster route to
market," Bentsur said.
Because chemotherapy administered by catheter drains rapidly from
the urinary tract, surgery has been the usual recourse.
To overcome this, UroGen developed RTGel, a liquid at lower
temperatures that converts to a gel at body temperature. The gel is
combined with chemo drug mitomycin to form MitoGel, which UroGen
says can prolong exposure of tumors to mitomycin to 6-8 hours from
just minutes.
"We believe MitoGel has a low bar for approval, as there are no
non-surgical therapies currently available," Cowen analyst Boris
Peaker said.
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UroGen is looking at applications beyond uro-oncology. It has a
license agreement with Allergan, which began a Phase 2 trial last
year for treating overactive bladder by replacing multiple
injections of Botox into the bladder with a single shot of BotuGel.
UroGen received $25 million from Allergan and could get another $200
million in milestone payments as well as royalties.
Other potential indications include painful urination and
incontinence.
Israeli insurer Menorah Mivtachim is UroGen's biggest shareholder
with 13.2 percent.
UroGen's chairman is urologist Arie Belldegrun, who sold cancer
therapy company Kite Pharma to Gilead Sciences last year for nearly
$12 billion.
Raymond James analyst Reni Benjamin said UroGen could be an
acquisition target.
"Can we be an M&A candidate? I think we can," Bentsur said, but
added: "We are fully committed to marketing on our own."
(Reporting by Tova Cohen; Editing by Mark Potter)
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