BOTOX
®
+ RTGel

BOTOX® + RTGel

Unmet need

OAB is a common group of urinary symptoms that include a sudden, uncontrolled urge to urinate, frequent urination, and, in some patients, uncontrollable leakage of urine.1,2

OAB can have a significant negative impact on quality of life through interruptions in sleep, work, social life, and exercise, and may be associated with psychological challenges.2

The prevalence of OAB is high, as large, population-based studies estimate OAB rates from 7% to 27% in men and 9% to 43% in women.1

Standard first-line treatment for OAB is pharmacologic management with anti-muscarinics or β3-adrenoceptor agonists.3

However, in the case of an inadequate response, BOTOX® (onabotulinumtoxin A) administered via injection into the bladder is also an approved therapy for OAB.3

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.

In October 2016, UroGen granted an exclusive worldwide license to Allergan to research, develop, manufacture, and commercialize pharmaceutical products formulated with our technology platform, RTGel and clostridial toxins, including BOTOX.

Allergan is currently evaluating an investigational drug formulation of BOTOX and RTGel for the treatment OAB.

Status

  • Allergan is conducting a phase 2 clinical trial of BOTOX/RTGel for the treatment of OAB, with the potential to evolve from multiple injections of BOTOX into the bladder to a single instillation of the novel formulation
    Learn more and enroll patients >
  • Under the terms of the license agreement, UroGen is eligible to receive additional payments from Allergan related to the achievement of certain development, regulatory, and commercial milestones, in addition to royalties on potential net sales

BOTOX is a registered trademark of Allergan plc.

References: 1. Corcos J, Przydacz M, Campeau L, et al. CUA guideline on adult overactive bladder. Can Urol Assoc J. 2017;11(5):E142-E173. 2. What is overactive bladder (OAB)? Urology Care Foundation website. https://www.urologyhealth.org/urologic-conditions/overactive-bladder-(oab). Accessed June 28, 2019. 3. Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment 2019. J Urol. 2019;10.1097/JU.0000000000000309 (Epub ahead of print).