Top-line Results from UGN-102 OPTIMA II Phase 2b Trial Expected by Year End 2020; On Track to Initiate Phase 3 ATLAS Trial by Year End
Achieved Jelmyto® Net Product Revenue of $3.5 Million in First Full Quarter of Commercialization
#URGN"announced financial results for the third quarter ended September 30, 2020 and provided an overview of the Company’s recent developments.
Business Highlights and Upcoming Milestones:
Jelmyto (mitomycin) for pyelocalyceal solution:
Since the June 1, 2020 launch of Jelmyto®, the first and only FDA approved non-surgical treatment option for adult patients with low-grade upper tract urothelial cancer (LG-UTUC), the Company has expanded prescriber usage, broadened awareness and increased coverage by commercial plans and Medicare.
As of November 1, 2020, 165 sites have been activated, which means they have completed their internal processes and have treated or are ready to treat patients; 13 sites have treated more than one patient.
The Company has received its C-Code, effective October 1, 2020, and continues to expect receipt of a J-Code in January 2021.
Final durability data from the Phase 3 OLYMPUS pivotal trial evaluating Jelmyto (UGN-101) in LG-UTUC is expected to be presented at a medical meeting by the end of the year.
Top-line final data from the OPTIMA II Phase 2b trial evaluating UGN-102 in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) is expected by the end of the year.
The Company remains on track to initiate ATLAS, a pivotal Phase 3 trial of UGN-102 by year end 2020. The trial will enroll approximately 600 patients and explore UGN-102 as a non-surgical treatment alternative compared to standard of care – transurethral resection of bladder tumor (TURBT) – in patients diagnosed with LG-IR-NMIBC. There are no drugs currently approved by the FDA as first-line treatment for LG-IR-NMIBC, a difficult-to-treat disease with approximately 80,000 addressable patients per year in the U.S. alone.
Third Quarter 2020 Financial Results:
Jelmyto Revenue: UroGen reported net product revenue of Jelmyto for the third quarter ended September 30, 2020 of $3.5 million.
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