UroGen Gets New U.S. Patent Allowance for Mitomycin-Based Products, Protecting Until Dec 2041

UroGen Pharma Ltd., a biotechnology company listed on Nasdaq under the ticker URGN, has announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application no. 18/535,108, titled "Material and Method for Treating Cancer." This patent pertains to the combination of UroGen's RTGel® technology with medac’s licensed proprietary lyophilized mitomycin formulation.

The patent will cover the use of UroGen's UGN-103 and UGN-104 development programs specifically aimed at treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC) respectively. Once issued, this patent will remain valid until December 2041, strengthening UroGen's intellectual property portfolio substantially.

Liz Barrett, President and CEO of UroGen, commented that the allowance of this patent is a significant advancement for their investigational programs targeting urothelial cancers. Barrett emphasized that the combination of UroGen's RTGel® technology with medac’s unique lyophilized mitomycin could offer benefits in terms of production, cost efficiency, supply, and convenience for patients. These advantages align with UroGen's broader vision of developing innovative treatments that improve patient care and drive long-term company growth.

In January 2024, UroGen formed a licensing and supply agreement with medac to develop UGN-103 and UGN-104. Subsequently, in April 2024, the FDA accepted UroGen’s Investigational New Drug (IND) application for UGN-103, and the company is currently preparing clinical sites for the ensuing study. A similar study for UGN-104 is expected to start in early 2025.

UGN-102 is another advanced formulation of mitomycin developed by UroGen for intravesical use, currently in Phase 3 clinical trials for LG-IR-NMIBC. Utilizing UroGen's proprietary RTGel® technology, this formulation aims to lengthen the exposure of bladder tissue to mitomycin, facilitating the non-surgical treatment of tumors. UGN-102 is administered through a standard urinary catheter by a healthcare professional in an outpatient setting. UroGen successfully completed the New Drug Application (NDA) for UGN-102 in August 2024, with potential FDA approval anticipated in early 2025, provided the NDA is accepted and given priority review.

UGN-103 and UGN-104, also being developed by UroGen, are designed to treat LG-IR-NMIBC and LG-UTUC respectively. UGN-103 leverages the RTGel® technology to simplify manufacturing and reconstitution processes while ensuring intellectual property protection until December 2041. UGN-104 is similarly based on RTGel® technology and aims to provide a non-surgical treatment option for LG-UTUC. It is projected to enter Phase 3 trials in early 2025.

UroGen Pharma Ltd. is headquartered in Princeton, New Jersey, with operations in Israel. The company focuses on developing and commercializing innovative treatments for urothelial and specialty cancers. Its RTGel® reverse-thermal hydrogel technology is designed to prolong the exposure of urinary tract tissues to medications, thereby potentially enhancing the effectiveness of local therapies.

Medac, the partner company in this venture, is a globally operating pharmaceutical company based in Germany. Established in 1970, Medac is committed to enhancing patients' quality of life by providing high-quality medical treatments. The company focuses on a range of therapeutic areas including rheumatology, urology, hematology, and oncology. Medac’s extensive product range includes both original products and generics, manufactured to high standards and distributed globally.