ITCA 650

ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia’s innovative technology platform, the Medici Drug Delivery System, a proprietary subcutaneous delivery system comprised of three unique technologies: osmotic mini-pump technology; high temperature therapeutic stabilization technology; and mini-pump placement technology.

ITCA 650 is designed to provide continuous and consistent exenatide therapy in a 3-month initiation dose, followed by consecutive 6-month maintenance doses. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist that is currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. If approved, ITCA 650 will be the only twice-yearly, injection-free GLP-1 therapy. ITCA 650 is designed so it can be placed in a simple, in-office procedure that lasts approximately 15 minutes from start to finish, with the actual placement lasting only about one minute. The pump is placed just under the skin of a patient’s abdomen. Replacement mini-pumps are placed with similar ease as the first. This therapy can offer the potential advantage of more effective glycemic control through continuous and consistent dosing.

Intarcia Therapeutics successfully completed the ITCA 650 FREEDOM global Phase 3 clinical trial program in late 2Q 2016. The New Drug Application (NDA) was submitted to the FDA for ITCA 650 in the treatment of type 2 diabetes on November 20, 2016, and the FDA accepted the NDA filing on February 3, 2017.

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