UGN-201

UGN-201

Unmet need

The majority of bladder cancer is non-muscle invasive and is often associated with favorable prognosis.1,2 However, high-grade NMIBC is associated with an increased risk of recurrence and progression.3

Of the approximately 80,000 new cases of bladder cancer in the United States every year, approximately 10% will present with high-grade NMIBC.4,5

Intravesical bacillus Calmette-Guérin (BCG) is the standard of care for first-line treatment of high-grade NMIBC.1,2 However, high rates of BCG failure highlight the need for additional therapies.3,6

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-201 is an investigational local immunotherapy for the treatment of high-grade NMIBC bladder cancer. It is a proprietary formulation of imiquimod, a toll-like receptor 7/8 (TLR7/8) agonist, that is known to elicit an immune response to bladder cancer.

Status

  • A phase 1b study suggested a preliminary efficacy signal associated with UGN-201 in patients with high-grade NMIBC
  • The US Food & Drug Administration (FDA) has granted Orphan Drug designation to UGN-201 for the treatment of high-grade NMIBC
  • UroGen continues to advance research on UGN-201 in combination with checkpoint inhibitors for the treatment of bladder cancer
References: 1. 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. 2. Chang SS, Boorjian SA, Chou R, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol. 2016;196(10):1021-1029. 3. Tang DH, Chang SS. Management of carcinoma in situ of the bladder: best practice and recent developments. Ther Adv Urol. 2015;7(6):351-364. 4. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018;68(1):7-30. 5. Kirkali Z, Chan T, Manoharan M, et al. Bladder cancer: epidemiology, staging and grading, and diagnosis. Urology. 2005;66(6 Suppl 1):4-34. 6. Sylvester RJ, van der Meijden APM, Witjes A, Kurth K. Bacillus Calmette-Guerin versus chemotherapy for the intravesical treatment of patients with carcinoma in situ of the bladder: a meta-analysis of the published results of randomized clinical trials. J Urol. 2005;174(1):86-91.