Benzinga | Jul 28, 2021 04:00PM EDT

UroGen Reports License, Supply Deal With Neopharm To Pursue Regulatory Approval, Commercialization Of Jelmyto In Israel

* Jelmyto(r) granted expedited review in Israel

* Jelmyto is the only US FDA approved treatment for low-grade upper tract urothelial cancer

PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (NASDAQ:URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, and Neopharm group ("Neopharm"), today announced an exclusive license for Neopharm to market and sell Jelmyto(r) (mitomycin) for pyelocalyceal solution in Israel, subject to regulatory approval. Jelmyto is the first and only U.S. Food and Drug Administration approved medicine for adult patients with low-grade upper tract urothelial cancer (LG-UTUC).

Neopharm will lead the regulatory process in Israel, which is supported by the results from the Phase 3 OLYMPUS trial that showed Jelmyto achieved clinically significant disease eradication in adults with LG-UTUC.

"We are excited to work with Neopharm and take the first step in making Jelmyto available to patients in Israel," said Liz Barrett, President and Chief Executive Officer of UroGen. "As we begin the process of geographic expansion for Jelmyto, it was important for us to prioritize Israel as the first opportunity to bring this innovative treatment to patients outside of the United States. Beyond the fact that our company was founded in Israel, and we continue to have a significant presence there, physicians and patients in Israel played a key role in the pivotal study that supported Jelmyto's approval in the United States."

Jelmyto, which received expedited approval in the United States in April 2020, is an innovative therapy utilizing UroGen's proprietary sustained release RTGel(tm) technology in combination with mitomycin, an established chemotherapy that inhibits DNA synthesis. It has been designed to dwell in the cavity, enabling mitomycin to have longer exposure to and broader coverage of urinary tract tissue, thereby allowing the treatment of tumors by non-surgical means.

"We look forward to working with UroGen to move Jelmyto through the regulatory process in Israel and to make this novel, non-surgical treatment available to appropriate patients as quickly as possible," said Efi Shnaidman, general manager of Neopharm Israel. "We are proud to be the first company outside the US to have started the regulatory approval and commercialization process for Jelmyto, demonstrating Israel's importance in geographic expansion. Moreover, it is exciting to work with another company who has deep roots in Israel. I am confident that our well-established expertise and heritage of collaboration with innovative biopharmaceutical companies will make Jelmyto a success in Israel."

In addition to Israel, UroGen continues to work with regulators and potential collaborators in key markets to explore opportunities for geographic expansion. UroGen is committed to bringing the promise of Jelmyto to as many patients as possible, as quickly as feasible.