UroGen Pharma (“UroGen” or the “Company”) is a clinical-stage biopharmaceutical company focused on developing novel therapies designed to change the standard of care for urological pathologies with a focus on uro-oncology. The lead drug candidates, MitoGel and VesiGel, are designed to potentially remove tumors by non-surgical means, to treat several forms of non-muscle invasive urothelial cancer, including low-grade bladder cancer and low-grade upper tract urothelial carcinoma, or UTUC. In addition, UroGen is developing an additional clinical-stage drug candidate, Vesimune, for the treatment of high-grade non-muscle invasive bladder cancer. The company has recently licensed BotuGel for the treatment of overactive bladder and interstitial cystitis, to Allergan for further development.
Unlike kidney and prostate cancers where several drug approvals have occurred in the last two decades, no drugs have been approved by the U.S. Food or Drug Administration (FDA) for non-muscle invasive bladder cancer in more than 15 years. With this minimal level of innovation, the bladder cancer patient population remains underserved, with several existing unmet medical needs. It is believed that the dearth of new therapies in bladder cancer is largely a result of insufficient effectiveness of existing locally-administered chemotherapy-based drugs and their inability to replace the Trans Urethral Resection of Bladder Tumor (TURBT) procedure as first line of therapy. The bladder is physiologically and anatomically unique in that it contains a significant amount of fluid and is also subject to pressure during urine voiding. This makes it challenging to prolong the dwell time and provide adequate coverage and tissue exposure of locally-administered drugs and consequently such drugs are only used in the adjuvant setting post-TURBT resection. These challenges are more profound in the upper tract where drug retention is highly limited, and contact time with tissue is minimal. The Company’s proprietary reverse thermal gelation hydrogel, RTGel™, is utilized for the new formation of locally-acting drugs, such as Mitomycin C, to significantly increase their dwell time, tissue coverage and exposure in order to improve efficacy without compromising safety and the natural flow of fluids in the bladder. This provides the opportunity, for the first time, to use chemotherapy based drugs as chemoablation agents with the potential to replace the TURBT resection procedure as first line therapy.