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Intarcia Supports American Diabetes Association Call For Independent Review Of Incretin-Based Therapies
Date:6/13/2013

p>About the FREEDOM Program
The FREEDOM program is designed to evaluate the safety and efficacy of ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes. Intarcia expects to enroll greater than 4,000 patients at more than 500 clinical trial sites in more than 30 countries. The clinical studies will cover a broad range of patients whose diabetes is not controlled by oral anti-diabetes medications including metformin and metformin-based combinations. FREEDOM-1 is a U.S.-only, placebo-controlled, double-blind study comparing ITCA 650 doses of 40 mcg/d and 60 mcg/d to placebo; the FREEDOM-2 study will be a 500-patient, global, active-comparator controlled, double-blind, double-dummy study in patients on metformin only, comparing ITCA 650 20 mcg/d for 13 weeks plus ITCA 650 60 mcg/d for 39 weeks to patients taking sitagliptin (Januvia®, Merck); FREEDOM-CVO is a global, placebo-controlled cardiovascular outcomes study that will examine the safety of ITCA 650 at 60 mcg/d vs. placebo in approximately 3,000 patients on a variety of approved anti-diabetes therapies.

About 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 proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy, and the company's proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time.

Data from Intarcia's ITCA 650 Phase 2 program have demonstrated significant and sustained reductions in HbA1c and body weight over 48 weeks of treatment with a marked reduction in the GI adverse events typically associated with the self-injection products in this class. ITCA 650 is an investigational new therapy and is not currently approve
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SOURCE Intarcia Therapeutics, Inc.
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