UGN-102

UGN-102

Unmet need

Bladder cancer accounts for approximately 90% to 95% of all new cases of urothelial cancer, with more than 80,000 new cases diagnosed in the United States every year.1,2 Bladder cancers are described as muscle invasive or non-muscle invasive based on whether they have invaded into the wall of the bladder.

The current standard of care for treating NMIBC patients is transurethral resection of bladder tumor (TURBT), followed by adjuvant chemotherapy or, in certain cases, immunotherapy at the discretion of the treating physician.3,4

TURBT is a surgical procedure performed under anesthesia in a hospital setting using a special scope called a resectoscope.5


Recurrence of disease is common after TURBT—30%-40% at 1 year and up to 70% at 5 years—and it is not unusual for patients to require multiple surgical procedures to control NMIBC over a lifetime, making bladder cancer one of the costliest cancer to treat in the United States.

There are currently no drugs approved by the US Food & Drug Administration (FDA) for first-line treatment of NMIBC—the 3 drugs approved for NMIBC are all used for adjuvant treatment.

Pipeline candidate

Urology Immuno- uro-oncology Uro-oncology Overactive bladder (OAB) BOTOX ® /RTGel TM reverse- thermal hydrogel High-grade non-muscle invasive bladder cancer (NMIBC) UGN-201 Low-grade non-muscle invasive bladder cancer (NMIBC) UGN-102 Low-grade upper tract urothelial carcinoma (UTUC) UGN-101 (orphan) REGISTRATION PHASE 3 PHASE 2 PHASE 1 NONCLINICAL PROGRAM CATEGORY

*Licensed to Allergan. The safety and efficacy of the above product candidates for the specified conditions have not been established.
BOTOX is a registered trademark of Allergan plc.

PHASE 2 BOTOX ® /RTGel TM reverse-thermal hydrogel Overactive bladder (OAB) Urology NON- CLINICAL UGN-201High-grade non-muscleinvasive bladder cancer (NMIBC) Immuno-uro-oncology PHASE 2 UGN-102Low-grade non-muscleinvasive bladder cancer (NMIBC) REGISTRATION UGN-101 (orphan)Low-grade upper tract urothelial carcinoma (UTUC) Uro-oncology

*Licensed to Allergan. The safety and efficacy of the above product candidates for the specified conditions have not been established.
BOTOX is a registered trademark of Allergan plc.

UGN-102 (mitomycin gel) is an investigational formulation that utilizes our innovative technology, RTGel reverse-thermal hydrogel, for the treatment of low-grade NMIBC.

Administered locally via standard catheters, UGN-102 is designed to fill and conform to the anatomy of the bladder and dwell for a period of several hours before being excreted via normal urine flow.

Status

  • UroGen has completed enrollment in a phase 2b study to further investigate UGN-102 for the treatment of intermediate-risk low-grade NMIBC
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References: 1. Rouprêt M, Babjuk M, Compérat E, et al. European Association of Urology guidelines on upper urinary tract urothelial carcinoma: 2017 update. Eur Urol. 2018;73(1):111-122. 2. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018;68(1):7-30. 3. Chang SS, Boorjian SA, Chou R, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol. 2016;196(4):1021-1029. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Bladder Cancer V.2.2017. © National Comprehensive Cancer Network, Inc. 2017. All rights reserved. Accessed June 26, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. 5. Babjuk M, Bohle A, Burger M, et al. EAU guidelines on non-muscle invasive urothelial carcinoma of the bladder: update 2016. Eur Urol. 2017;71(3):447-461.