Expanding access to Jelmyto outside of the U.S.
Named Patient Program
Patients facing illnesses who have exhausted all available treatment options often want to know if and how they can receive early access to medicines that are not yet available in their country of residence.
UroGen® has engaged Tanner Pharma Group to administer a Named Patient Program for Jelmyto® (mitomycin) for pyelocalyceal solution in select countries where Jelmyto is currently not available or approved for use by the local regulatory authority.
This program provides controlled, pre-approval access to Jelmyto in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where Jelmyto has not yet received a marketing authorization and in situations when patients have exhausted all available treatment options.
It is important to remember that potential risks and benefits are not yet established for medicines that have not received regulatory approval by the local government regulatory bodies. Healthcare providers and patients should consider all possible benefits and risks when seeking access to an unapproved medicine in their local jurisdiction.
Healthcare providers should direct Named Patient Program requests to Tanner Pharma Group via:
- Email: jelmyto@tannerpharma.com
- Tel: +44 (0) 20 39408 111
Patients seeking access to Jelmyto are advised to consult directly with their healthcare provider.
Jelmyto is available
in Israel
UroGen has granted Neopharm group (Neopharm) an exclusive license and supply agreement to market and sell Jelmyto® (mitomycin) for pyelocalyceal solution in Israel. Jelmyto is now approved by the Israeli Ministry of Health for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer and is available in Israel.
Neopharm Israel is part of the privately owned Neopharm Group which, through its family of companies, engages in the research and development, manufacturing, marketing, sales and distribution of a broad range of products in the healthcare market in more than 60 countries worldwide.
It was important for UroGen to prioritize Israel as the first country outside of the United States to have this innovative treatment commercially available. UroGen was founded in Israel, and physicians and patients in Israel played a key role in the pivotal study that supported Jelmyto’s U.S. approval.
Innovating for patients
with urothelial cancers
Exclusive License for a Next-Generation Mitomycin-Based Formulation
UroGen has entered into a license and supply agreement with medac GmbH to develop next-generation products by combining our proprietary RTGel® technology with medac’s proprietary formulation of mitomycin. UroGen is developing two new formulations including an 80 mg formulation of mitomycin plus RTGel® technology for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC), designated UGN-103, and a separate formulation for low-grade upper tract urothelial carcinoma (LG-UTUC), designated UGN-104.
If approved, these next-generation products in development are anticipated to provide advantages in production, manufacturing efficiency, supply, and product convenience. Importantly, the program could provide additional patent protection for our urothelial cancer franchise. Medac has issued patents with protection expected to last until 2035 and UroGen has separate pending U.S. patent applications that, if granted, could provide protection until December 2041.
UroGen plans to initiate Phase 3 studies in 2024 to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC and UGN-104 in LG-UTUC. UroGen’s partnership with medac fortifies UroGen's commitment to continuously innovate novel, nonsurgical treatments for patients with urothelial cancers.