May 28, 2016 1:22 AM ET

Biotechnology

Company Overview of Intarcia Therapeutics, Inc.

Company Overview

Intarcia Therapeutics, Inc., a biopharmaceutical company, develops therapies to enhance treatment outcomes by optimizing and improving the administration and tolerability of drug therapies. The company develops ITCA 650, a Phase 3 clinical program for type 2 diabetes that consists of 4 separate clinical trials. Its products includes a cylindrical titanium alloy reservoir that is inserted under the skin that allows 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 through t...

155 Seaport Boulevard

11th Floor

Boston, MA 02210

United States

Founded in 1995

35 Employees

Phone:

617-936-2500

Fax:

510-652-2657

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 Therapeutics, Inc. Announces Cardiovascular Safety Results in Phase 3 FREEDOM-CVO Trial for ITCA 650

Intarcia Therapeutics, Inc. announced top-line results from its more than 4,000 patient Cardiovascular Safety Study (FREEDOM-CVO trial), clearing the last major clinical hurdle in the global FREEDOM Phase 3 Clinical Trial Program that started in early 2013. The company also announced a $75 million round of debt financing timed to facilitate ongoing scale-up of manufacturing and the production of inventory for the anticipated global launch of ITCA 650 in type 2 diabetes. The new credit facility is with MidCap Financial and Silicon Valley Bank. The FREEDOM-CVO Safety Trial is the fourth and final Phase 3 clinical trial of the FREEDOM program. It is a global, placebo-controlled cardiovascular outcomes study designed to meet the pre-approval safety assessment requirements set out in the U.S. Food and Drug Administration’s Guidance for Industry to evaluate cardiovascular risk for new therapies to treat type 2 diabetes. FREEDOM-CVO evaluated the safety of ITCA 650 at 60 micrograms per day vs. placebo in just over 4,000 patients on a variety of approved standard of care anti-diabetes therapies. The duration of study was dependent on event-based outcomes, and lasted just under 3 years, reaching the target number of cardiovascular events in the fourth quarter of 2015. The average treatment duration in FREEDOM-CVO was 1.2 years. Age eligibility for the study was 40 years and older. Inclusion criteria stipulated patients must have HbA1c > 6.5%, a history of coronary, cerebrovascular or peripheral artery disease, or multiple CV risk factors. The primary objective was to conduct a meta-analysis across FREEDOM-CVO and other phase 3 studies to demonstrate that the upper limit of the 95% confidence interval of the hazard ratio of major adverse cardiac events (MACE) in adult patients on Standard of Care for type 2 diabetes receiving either ITCA 650 or placebo, does not exceed 1.8. There were a total of 160 strict MACE events observed in the FREEDOM-CVO trial. The overall safety and tolerability data for ITCA 650 was consistent with the three phase 3 trials that have already been presented and what is documented in the published literature for exenatide and other GLP-1 receptor agonist therapies. Intarcia is also preparing to conduct additional head-to-head superiority studies against leading oral and injectable medicines. Some of the comparative trials will start this year, while other trials are planned to start with payers after approval to evaluate the relative performance of ITCA 650 vs. other type 2 diabetes therapies in ‘real-world’ settings where poor adherence and poor control with pills and self-injections are best assessed.

Intarcia Therapeutics, Inc. Appoints Anthony Hurley as VP, Global Commercial Manufacturing and Operations

Intarcia Therapeutics, Inc. announced that Anthony Hurley has joined the company in the role of VP, Global Commercial Manufacturing and Operations, based in Hayward, CA. Tony is an executive officer of the company and serves as a member of the Leadership Team, reporting directly to Chairman, President and CEO, Kurt Graves. Most recently Tony served as Genentech's VP, Head of Global External Manufacturing – Biologics. He spent the last eleven years of his career at Genentech in positions of increasing responsibility including Head of South San Francisco Manufacturing Operations and Head of Global Quality Biologics for both Drug Substance and Drug Product. His immediate responsibilities at Intarcia will be to provide the manufacturing support for the potential global launch of Intarcia's novel drug-device platform to treat type 2 diabetes. Specifically, Mr. Hurley will lead and continue to build out the commercial manufacturing team necessary to accomplish the commercial production/scale-up and facility expansions in the U.S. and abroad. The new position is part of Intarcia's rapid expansion to bring new capabilities in-house to further advance the company's disruptive innovations to market so that one of the world's most prevalent, costly and devastating chronic diseases - type 2 diabetes – might be more effectively addressed. He will serve as an executive leader in the company broadly, shouldering a large and mission-critical responsibility for the scale-up of ITCA 650 for planned global launch. Tony and the rest of the team in Hayward will also finalize plans and important work on second manufacturing facility in Ireland, and eventually progressing novel pipeline programs when they reach the right stage of development. Prior to his decade-long career in senior positions at Genentech, Inc., Mr. Hurley spent seventeen years in positions of increasing responsibility at GlaxoSmithKline (GSK) from 1987 to 2004, beginning as a Primary Plant Process Engineer and advancing through the ranks to his most senior role as Site Director, Upper Merion Anti-Infectives Operations, where he oversaw 280 employees. Before this, Tony spent two years as at Schering Plough as a Pilot Plant Engineer/Supervisor.

Intarcia Therapeutics, Inc. Appoints John Yee as Vice President, Head of Global Medical Affairs, Safety and Operations

Intarcia Therapeutics, Inc. announced the appointment of John Yee, MD, MPH, into the newly created role of Vice President, Head of Global Medical Affairs, Safety and Operations. Dr. Yee has two decades of leadership experience at leading pharmaceutical, biotechnology, and health care companies, and at a major academic medical center. Most recently Dr. Yee served as VP, Head of Medical Affairs, US Diabetes, and VP, US Head Medical Officer at AstraZeneca, where he led medical affairs across all therapeutic areas, and led the medical launch of multiple cardiovascular and metabolic products, including: Bydureon® (exenatide extended-release) for injectable suspension, Farxiga® (dapagliflozin), Xigduo™ XR (dapagliflozin and metformin HCI extended release tablets), Myalept® (metreleptin) for injection, and Brilinta® (ticagrelor tablets). In his new role at the company, Dr. Yee will be a member of the Leadership Team and an Executive Officer of the company, and he will report directly to Kurt Graves, Chairman, President and CEO.

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