October 25, 2014 6:29 PM ET

Biotechnology

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 offers ITCA 650 for the treatment of type 2 diabetes by using its subcutaneous delivery system (its technology platform), 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 of travel, and forces the drug formulation to be relea...

155 Seaport Boulevard

11th Floor

Boston, MA 02210

United States

Founded in 1995

35 Employees

Phone:

617-936-2500

Key Executives for Intarcia Therapeutics, Inc.

Executive Chairman
Age: 46
Chief Financial Officer and Vice President of Finance & Operations
Age: 50
Chief Legal Officer
Age: 55
Chief Business Officer and Head of Corporate Development
Age: 39
Vice President of Development & Manufacturing
Age: 55
Compensation as of Fiscal Year 2014.

Intarcia Therapeutics, Inc. Key Developments

Intarcia Therapeutics, Inc. Announces the Positive Interim Clinical Data of Phase 3 Data at EASD

Intarcia Therapeutics, Inc. announced the positive interim clinical data for it’s lead candidate ITCA 650 (continuous subcutaneous delivery of exenatide) in type 2 diabetes patients with high baseline HbA1c levels at the 50(th) Annual Meeting of the European Association for the Study of Diabetes (EASD). Data from the open-label, phase 3 FREEDOM-HBL (high baseline) trial showed markedly reduced levels of blood sugar in patients with poorly controlled type 2 diabetes. The overall results from the full 9-month HBL study and the FREEDOM-1 trial are expected to be announced in the fourth quarter of 2014. The results and conclusions are FREEDOM-1 is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of ITCA 650 in type 2 diabetes patients with an HbA1c between 7.5% and 10.0; Patients who met all inclusion criteria for FREEDOM-1 but had HbA1c greater than or equal to 10% but less than or equal to 12% were enrolled in FREEDOM-HBL; On average, patients enrolled to FREEDOM-HBL had been diagnosed with T2D for 9 years and a majority was being treated with multiple background oral anti-diabetes therapies; enrolling patients with high baseline HbA1c provides a robust opportunity; o evaluate treatment response in a poorly controlled patient population. In this interim analysis, the addition of ITCA 650 resulted in mean HbA1c reductions greater than 3% in patients who reached 6 months of treatment. 30% of patients who reached 13 weeks of treatment (n=50) achieved the target HbA1c of less than 7%. ITCA 650 treatment was also accompanied by weight loss, which is not commonly observed in the treatment of patients with high baseline HbA1c. ITCA 650 has the potential to markedly improve glycemic control patients with severe hyperglycemia and longstanding diabetes. ITCA 650 may offer potential benefits over existing oral and injectable therapies for type 2 diabetes via sustained glycemic control, favorableweight profile, improved tolerability, ensured adherence with once- or twice-yearly dosing, and no injections.

Intarcia Therapeutics, Inc. Appoints Sunita Zalani as Vice President, Global Head of Regulatory Affairs and Quality

Intarcia Therapeutics, Inc. announced the appointment of Sunita Zalani, Ph.D., as Vice President and Global Head of Regulatory Affairs and Quality. In her new capacity, Dr. Zalani serves on the Leadership Team and reports directly to Chairman, President & CEO Kurt Graves. The key new hire comes at a time when Intarcia is building out the company and 'rounding the corner' toward its first Phase 3 milestone later this year, with several others to follow in 2015. Just prior to joining Intarcia, Dr. Zalani worked at Onyx Pharmaceuticals as Vice President of Global Regulatory Affairs.

Intarcia Therapeutics, Inc. Presents Interim Phase 3 Data From FREEDOM 1 HBL

Intarcia Therapeutics, Inc. announced the highlights of a poster presentation at the 74(th) Scientific Sessions of the American Diabetes Association (ADA) held in San Francisco that contained the first 6-month data from an ongoing open-label phase 3 trial with ITCA 650 in type 2 diabetes. Patients in the trial had longstanding disease and significantly elevated HbA1C levels between 10%-12% despite treatment that included diet, exercise and antidiabetes medications. Nearly 70% of patients in the trial at baseline had very poor glucose control despite being treated with 1, 2 and even 3 oral diabetes therapies. The interim data showed marked improvements in glycemic control among patients with severe hyperglycemia and longstanding type 2 diabetes. The data includes the first 6-month, open-label experience with ITCA 650 mini-pumps from an ongoing multicenter study in subjects with type 2 diabetes who did not meet enrollment criteria for the double-blind placebo controlled trial because their HbA1C was greater than 10%, a population who is not appropriate for a placebo controlled trial. This open-label HBL study enrolled a total of 60 patients who met all of the qualifications for the double-blind study except for elevated blood sugar levels and an HbA1C between 10-12%. Entrance criteria for the open-label trial included: HbA1C >10% to <=12%, age 18-80 years, BMI 25-45 kg/m2, a stable regimen (>=3 months) of diet and exercise and/or mono, or combination therapy with any combination of metformin, sulfonylurea, and thiazolidinedione.

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