First surgery-free treatment option for rare, difficult-to-treat urinary tract cancer requires complex clinical protocol
BANNOCKBURN, Ill., May 21, 2020 (GLOBE NEWSWIRE) — Option Care Health, Inc. (“Option Care Health” or the “Company”) (NASDAQ: OPCH), the nation’s largest independent provider of home and alternate site infusion services, has been selected by UroGen Pharma (NASDAQ: URGN) as a preferred national pharmacy provider to prepare and deliver a first-of-its-kind cancer treatment, Jelmyto™ (mitomycin) for pyelocalyceal solution.
The new formulation offers a novel approach for treating adults with low-grade upper tract urothelial cancer (LG-UTUC), targeting tumors directly with a drug that changes form as it warms and must be provided by the physician within eight hours of preparation. To ensure the drug will be prepared, shipped and provided to the patient within the required time period and in accordance with product labeling requirements and pharmacy standards, Option Care Health partnered with UroGen to create an innovative pharmacy solution to support Jelmyto via its nationwide sterile compounding pharmacy and distribution network.
Approved by the U.S. Food and Drug Administration on April 15, 2020, Jelmyto is a first-in-class treatment consisting of mitomycin – an established chemotherapy – and sterile hydrogel, using UroGen’s proprietary sustained release RTGel™ technology. It has been designed to enable longer exposure of urinary tract tissue to mitomycin, facilitating the treatment of these rare and difficult-to-treat cancerous tumors with a non-surgical, kidney-sparing option.
Jelmyto must be prepared in USP 800-compliant pharmacies that use heightened quality and safety standards and, in addition to compounding rooms, they must have expanded capabilities and expertise to process cytotoxic drug components. Option Care Health’s national network of USP 800 pharmacies will prepare the formulation pursuant to patient-specific Jelmyto prescriptions and deliver it to the urologist within the required time period and in accordance with the exacting standards of the Jelmyto Instructions for Pharmacy.
“Option Care Health’s infrastructure and compounding capabilities in our network of USP 800-compliant pharmacies are unparalleled, allowing us to provide comprehensive services in collaboration with UroGen,” said John C. Rademacher, President and Chief Executive Officer of Option Care Health. “Every day Option Care Health ensures thousands of patients receive their required therapies in a safe and timely manner. The investments we have made in our clinical infrastructure enable us to partner with UroGen to deliver this innovative new therapy.”
“UroGen is challenging the standard of care through novel, non-surgical treatment alternatives such as Jelmyto, which leverages our innovative technology and expertise in specialty cancers and urologic diseases,” said Liz Barrett, UroGen President and Chief Executive Officer. “Jelmyto requires complex preparation and timely delivery and Option Care Health offers the national scale, depth of experience, expertise and commitment to quality that we require in a partner to ensure patients receive this vital new therapy in a timely and safe manner.”
LG-UTUC is a rare cancer that develops in the lining of the upper urinary tract, ureters and kidneys. Every year approximately 6,000 to 7,000 U.S. patients are diagnosed with new or recurrent LG-UTUC. It is challenging to treat due to the complex anatomy of the urinary tract system. The current standard of care includes multiple surgeries and often a radical nephroureterectomy, including the removal of the renal pelvis, kidney, ureter and bladder cuff.
About Option Care Health
Option Care Health is the nation’s largest independent provider of home and alternate site infusion services. With over 5,000 teammates, including approximately 2,900 clinicians, we work compassionately to elevate standards of care for patients with acute and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health is re-imagining the infusion care experience for patients, customers and employees. To learn more, please visit our website at OptionCareHealth.com.
About UroGen Pharma Ltd.
UroGen is a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options. UroGen has developed RTGel™ reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s approved Jelmyto™ (mitomycin) for pyelocalyceal solution, and pipeline treatment UGN-102 (mitomycin) for intravesical solution are designed to ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer and low-grade non-muscle invasive bladder cancer, respectively. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on Twitter, @UroGenPharma.
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