Jelmyto Poised for Successful Commercial Launch

UroGen Pharma (UroGen) is preparing to bring the first non-surgical treatment option for low-grade upper tract urothelial cancer (LG UTUC) to patients who are in critical need of a better option.

In late 2019, the FDA accepted for filing and granted Priority Review for UroGen’s NDA for the treatment of patients with low-grade UTUC. Recently, the FDA granted expedited approval for Jelmyto (mitomycin) for pyelocalyceal solution, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (LG UTUC).

LG UTUC is a rare cancer that develops in the lining of the upper urinary tract, ureters and kidneys. In the U.S., there are approximately 6,000 – 7,000 new or recurrent LG UTUC patients annually. It is a challenging condition to treat due to the complex anatomy of the urinary tract system and further complicated by the fact that LG UTUC is most commonly diagnosed in patients over 70 years of age.

UroGen has been preparing for the commercialization of Jelmyto by increasing customer awareness and discussing the high unmet need in low-grade UTUC. UroGen company research revealed that only about 30% of physicians were even aware of UroGen and UGN-101 in 2018, increasing to 70% in 2019. Research also showed that 88% of urologist desire a new and differentiated treatment option for their patients

UroGen has developed an account-bases sales force of 48 representatives who will be able to reach 90% of the patient population. Company support includes seven regional business managers, seven clinical nurse educators to provide training and support around installation and seven field reimbursement managers to ensure access and reimbursement. The company has also developed a team of seven MSLs who have contacted physicians interested in learning more about UroGen and its technology.

Since Jelmyto is a buy-and-bill drug, UroGen has developed a comprehensive program to assist physicians in securing reimbursement physicians while field reimbursement managers will be onsite to ensure success. UroGen has also contracted with a hub services provider to assist with access and reimbursement.

Takeaway: Jelmyto has positioned UroGen for leadership in the low-grade upper tract urothelial cancer market.