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Intarcia Enrolls First Patients in "FREEDOM" Global Phase 3 Program for ITCA 650 in Type 2 Diabetes
Date:3/21/2013

months; secondary endpoints include changes in weight, FPG, PPG, tolerability, and other measures of safety and efficacy.

Michelle Baron , MD, FACE, Vice President and Chief Medical Officer of Intarcia, commented on the initiation of the FREEDOM Phase 3 program: "We named our program 'FREEDOM' in recognition of the burden that patients with type 2 diabetes face every day of their lives, and our sincere hope that ITCA 650 will alleviate some of that burden by achieving glucose control in a manner that optimizes patient adherence to therapy. It is well documented that sub-optimal adherence to medication results in poor outcomes and disproportionately higher medical costs. Our goal is to demonstrate that ITCA 650 can successfully deliver up to a full year of treatment from a single placement of the mini-pump – a potential breakthrough in addressing a huge unmet need in this chronic disease. We expect these studies to support regulatory submissions in both the U.S. and the EU, and anticipate the first clinical results in the second half of 2014."

"Our vision is to unleash a game-changing type 2 diabetes treatment that is so innovative and disruptive that it could truly reshape the standard of care and enable far better outcomes for the many patients suffering from this devastating disease," said Kurt Graves , Chairman, President and CEO of Intarcia. "Years of innovation and tenacity have paved the way for the first potential once-yearly type 2 diabetes medicine and the start of the FREEDOM program. We firmly believe that a once-yearly GLP-1 therapy that virtually ensures long-term compliance can do extremely well in any real-world outcomes comparative trials and in the payor-driven and outcomes-focused healthcare environment of the future. As a Company committed to delivering superior outcomes for patients, physicians, and payors, the enrollment of the first patient in our FREEDOM clinical s
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SOURCE Intarcia Therapeutics, Inc.
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