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; mini-pump placement technology; and our high temperature therapeutic stabilization technology.

ITCA 650 is designed to provide continuous and consistent exenatide therapy in a 3-month initiation dose, followed by consecutive 6-month 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. When 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 insertion lasting only about one minute. The pump is placed just under the skin of a patient’s abdomen. Replacement mini-pumps are inserted with similar ease as the first, offering the potential advantage of more effective glycemic control through assured continuous and consistent dosing.

Intarcia Therapeutics recently completed the ITCA 650 FREEDOM global Phase 3 clinical trial program. Regulatory filing in the U.S. is expected in 4Q 2016.

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