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November 30, 2015 3:23 PM ET


Company Overview of Intarcia Therapeutics, Inc.

Company Overview

Intarcia Therapeutics, Inc., a biopharmaceutical company, develops treatments to optimize therapeutic benefits and reduce adverse effects for chronic and life-threatening diseases. The company provides ITCA 650 for the treatment of type 2 diabetes by using its subcutaneous delivery system technology, which is a matchstick-sized device, including a cylindrical titanium alloy reservoir that is inserted under the skin to allow the water from the extracellular fluid to enter the device at one end by diffusing through a semi-permeable membrane directly into a salt osmotic engine that expands to drive a piston at a controlled rate, and forces the drug formulation to be released in a consistent way...

155 Seaport Boulevard

11th Floor

Boston, MA 02210

United States

Founded in 1995

35 Employees



Key Executives for Intarcia Therapeutics, Inc.

Executive Chairman, Chief Executive Officer and President
Age: 47
Chief Financial Officer and Vice President of Finance & Operations
Age: 51
Chief Operating Officer
Chief Scientific Officer and Vice President
Chief Legal Officer, Vice President and General Counsel
Age: 56
Compensation as of Fiscal Year 2015.

Intarcia Therapeutics, Inc. Key Developments

Intarcia Announces New Top-Line Phase 3 Results for Investigational Therapy ITCA 650 In Type 2 Diabetes

Intarcia Therapeutics, Inc. announced positive top-line results from its 52-week Phase 3 FREEDOM-2 clinical trial to determine the comparative efficacy of the company's late-stage investigational candidate ITCA 650 to Merck's Januvia in reducing HbA1c in patients with type 2 diabetes following a year of treatment. All patients were on background metformin monotherapy. ITCA 650 is an injection-free GLP-1 receptor agonist in development that continuously delivers exenatide with just once or twice-yearly dosing via a small matchstick-size subdermally placed osmotic mini-pump. In the FREEDOM-2 trial, ITCA 650 met all primary and secondary endpoints, demonstrating superiority over Januvia at every measured time point through and including week 52 endpoints for reduction in HbA1c and reduction in body weight (BW). ITCA 650 is not yet being investigated for the management of obesity. Significantly more patients on ITCA 650 60mcg versus Januvia 100mg achieved the secondary composite endpoint combining glucose reductions of > 0.5% and weight reductions of 2 kg or greater; ITCA 650 results were superior versus Januvia 100mg. Significantly more patients on ITCA 650 60mcg achieved the ADA-recommended HbA1c target of < 7.0% versus Januvia 100mg; ITCA 650 results were superior versus Januvia 100mg. In the FREEDOM-2 trial, ITCA 650 60 mcg/d also demonstrated an overall and G.I. tolerability profile similar to prior Phase 3 results recently presented at ADA in the FREEDOM-1 placebo-controlled trial. Discontinuations for nausea were in the low single digits over the full 12 months of treatment. There were no cases of major hypoglycemia in either study arm and minor events of hypoglycemia were reported in the low single digits for both study arms. The placements and removals of ITCA 650 were very well tolerated and the rate of minor infections at the application site was less than 1% of all procedures in the trial.

Intarcia Therapeutics, Inc. Announces Presentation of Results from its First Two Phase 3 Clinical Trials

Intarcia Therapeutics, Inc. announced the presentation of results from its first two phase 3 clinical trials (FREEDOM-1 and FREEDOM-1 HBL) of its late-stage investigational candidate ITCA 650 (exenatide delivered continuously via a small matchstick-size subcutaneous osmotic mini-pump just once or twice yearly) at the 75th Scientific Sessions of the American Diabetes Association. Results showing positive data on key endpoints from the trials were highlighted in an oral presentation and a poster session at the conference in Boston. Oral Presentation of FREEDOM-1 Results Oral Presentation of FREEDOM-1: 'Clinical Impact of ITCA 650 in Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled 39 Week Trial,'. FREEDOM-1, a placebo-controlled study, demonstrated positive results for ITCA 650 when added to diet and exercise with or without standard oral diabetes medications, for those patients who were not at goal. All key endpoints were met, including significant reductions in HbA1c and weight, and the percentage of patients treated to goal. ITCA 650 produced significant and sustained mean reductions in HbA1c of 1.4% at 39 weeks of treatment (mITT population). Two pre-specified patient populations were assessed to determine how HbA1c reductions may vary based on whether or not patients were on a background regimen including a sulfonylurea (SU)-based regimen, or a metformin or diet & exercise regimen without any SUs. Non SU-containing Regimens: Patients primarily on background metformin (40% of patients), or diet and exercise (11% of patients), showed a mean HbA1c reduction of 1.7%. SU-containing Regimens: Those on an SU-based background regimen (47% of patients) had a mean HbA1c reduction of 1.2%. Significant and progressive weight loss that was dose dependent was observed over 39 weeks (mITT population). Patients on the primary phase 3 dosing regimen lost a mean of 4 kg in the 60 mcg/d ITCA 650 dose group vs. 2 kg in the placebo group at Week 39, which was statistically significant. The overall tolerability profiles, including G.I. events, were very similar between the 40 mcg/d and the higher 60 mcg/d dose groups. There was a low single-digit discontinuation rate for nausea. No new safety findings were identified compared to what is known for the GLP-1 receptor agonist class. Other adverse events associated with the administration site and the procedures to place and remove the ITCA 650 were generally mild and transient. Discontinuations due to procedures and administration site adverse events were also a very low single digit rate across each arm of the 39-week study.

Intarcia Therapeutics, Inc. Names Emad Rizk to Board of Directors

Intarcia Therapeutics, Inc. announced the appointment of Emad Rizk, MD, to its board of directors. Dr. Rizk is a well-respected leader in the healthcare industry, and an expert on payers and healthcare economics. He joins the company board as the company nears completion of its clinical development for ITCA 650 (a once- or twice-yearly continuous subcutaneous delivery of exenatide), its lead therapeutic candidate for the treatment of type 2 diabetes. Dr. Rizk currently serves as President and Chief Executive Officer of Accretive Health. He previously served as President of McKesson Health Solutions. Dr. Rizk was formerly a member of the board of DMAA: Care Continuum Alliance and currently serves on the boards of directors of the National Association for Hispanic Health, Manage Care Editorial, Accuray Inc. and Accretive Health.

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