UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced a licensing agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers.

UGN-103, UroGen’s RTGel technology combined with medac’s licensed mitomycin, is a next-generation formulation that is planned to follow the anticipated U.S. Food and Drug Administration approval and launch of UGN-102. UGN-103 is expected to provide advantages related to production, cost, supply, and product convenience if approved. UroGen plans to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC.

"The strategic alliance with medac fortifies our commitment to continuously innovate novel, non-surgical treatments for patients with urothelial cancers, including LG-IR-NMIBC,” said Liz Barrett, President and CEO of UroGen. "The 80 mg formulation of mitomycin from medac is specifically designed to be mixed with our RTGel technology, which may provide advantages for patients looking for non-surgical treatments for urothelial cancer. With medac's intellectual property protection for this next-generation mitomycin formulation lasting until June 2035 and our pending U.S. patent applications, we foresee potential intellectual property protection until December 2041."

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024 and an FDA decision in 2025.

About UroGen Pharma Ltd.

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat LG-UTUC and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on X (Twitter), @UroGenPharma.