The FDA approved Urogen Pharma Ltd.’s mitomycin gel, an orphan drug branded Jelmyto, on April 15, offering patients the first non-surgical option for low-grade upper tract urothelial cancer (LG-UTUC) and granting the Princeton, N.J.-based company with its first marketed product.

The approval arrived three days ahead of the April 18 PDUFA date.

The recommended dose is 4 mg per mL given via a ureteral catheter or nephrostomy tube, not exceeding 15 mL (60 mg mitomycin). The drug, formerly called UGN-101, was approved based on the 71-patient Olympus trial in which 41 patients achieved a complete response three months after treatment initiation.

“We expect a timely launch by a highly experienced sales force,” said analyst Raghuram Selvaraju, of H.C. Wainwright & Co., in a research note dated April 13.

His firm reported a peak sales estimate of $667 million and pricing of around $120,000 per patient in the U.S. The company, which estimates there are about 6,000 to 7,000 treatable patients with LG-UTUC in the U.S. each year, has said it is on track for a launch midyear 2020.

Urogen could achieve cash flow breakeven in 2022, Selvaraju said, but the firm reduced its price target to $53 from $75 per share. The company’s stock (NASDAQ:URGN) dropped nearly 14.71%, or $3.63, on April 15, to close at $21.04. The stock was ramping up for most of the month and ended the day of the approval still 28% above its closing on April 1.

The internal team consists of a 48-member sales force, all with urology or oncology expertise having promoted such products as Xofigo (radium Ra 223 dichloride, Bayer AG), Provenge (sipuleucel-T, Sanpower Group), Xtandi (enzalutamide, Pfizer Inc.) and Zytiga (abiraterone acetate, Johnson & Johnson), Selvaraju said. The company also has put in place regional business managers, nurse educators, field reimbursement managers and medical science liaisons.

“Based on recent market research, 88% of urologists desire a new and differentiated treatment option for their patients,” Selvaraju said.

The current standard of care is the complete removal of the kidney and upper urinary tract or an endoscopic tumor resection followed by mitomycin treatment.

“Given these considerations, we consider our near-term forecasts readily attainable and continue to feel bullish about UGN-101's prospects,” Selvaraju said, “even given the concerns over the social distancing restrictions imposed due to the COVID-19 pandemic.”

Urogen has prepared a virtual sales model to launch the product as well as an instructional video for doctors, who likely will prefer a therapy in which 75% of patients will not require general anesthesia.

Jelmyto, which is based on Urogen’s RTGel reverse-thermal hydrogel platform, is instilled intravesically in liquid form directly into the bladder or upper urinary tract, converts into a gel at body temperature and gradually dissolves upon contact with urine, releasing over several hours the active drug, which then serves as a chemoablation agent.

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