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.
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.
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)
