Intarcia Supports American Diabetes Association Call For Independent Review Of Incretin-Based Therapies

BOSTON, June 13, 2013 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced its support for the American Diabetes Association's (ADA) call for larger, longer-term, and more rigorous datasets and an independent review of pooled data on the safety of incretin-based diabetes medications, including GLP-1 analogs and DDP-4 inhibitors. The ADA made its announcement ahead of this week's NIDDK-NCI Workshop. Intarcia is currently conducting Phase 3 studies of its lead development candidate, ITCA 650, as a once- or twice-yearly treatment for patients with type 2 diabetes. ITCA 650 contains exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist.

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"Intarcia is an evidence-based company and nothing is more important than the safety of our medicines, transparency of data, and the appropriate and beneficial use of our medicines at every stage of development and once on the market," said Kurt Graves, Chairman, President and CEO of Intarcia. "We fully support the ADA's leadership here, their call to incretin therapy companies for all relevant patient-level data, and bringing their independent expertise to bear on the right questions and the best data to answer them. We are pleased to contribute the data as they become available from our ongoing FREEDOM global Phase 3 program, which is designed to include at least 4,000 patients."

Michelle Baron, MD, FACE, Chief Medical Officer of Intarcia, commented on the ADA announcement as well:  "Intarcia is committed to and focused on patient safety above all else.  For the good of patients and to further scientific knowledge, we pursue the highest quality and most rigorous research, and we welcome the opportunity to contribute our evidence."

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 approved by any regulatory authority. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver a full year of treatment from a single placement. Intarcia's robust intellectual property portfolio protects ITCA 650 through 2031.

About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. In addition, delivering medicines just once or twice yearly virtually ensures patient adherence and compliance, which is very poor in most chronic diseases. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above-body temperature and to deliver them in a constant and consistent manner via Intarcia's proprietary technology platform. Intarcia is pursuing a Phase 3-stage development program for type 2 diabetes and has additional programs ongoing for weight regulation to control obesity. For more information on the Company, please visit www.intarcia.com.

Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.

SOURCE Intarcia Therapeutics, Inc.