Intarcia and Calibr Announce Collaboration and In-Licensing Deal Aimed at Delivering a Next Generation Combination Product for Diabetes and Obesity

Under the terms of the agreement, Calibr will receive an upfront grant of Intarcia equity, with additional shares vesting over key development milestones, as well as undisclosed cash payments on achievement of predetermined regulatory and sales milestones.  In addition to the milestone payments, Calibr will be eligible to receive tiered royalties on product sales.

Kurt Graves, Chairman, President and CEO of Intarcia Therapeutics, commented: "We are committed to disruptive innovation leveraging our proprietary Medici Drug Delivery System^TM and we now have several combination products in our pipeline that we believe we can uniquely optimize and deliver in a once- or twice-yearly mini-pump.  We're excited to advance a combination program with Calibr that is targeting significant advances for patients suffering from type 2 diabetes and obesity."

"This collaboration is another example of Calibr's drive to work with innovative partners who are committed to making a difference in human health," said Matt Tremblay, Ph.D., Calibr's Chief Operating Officer. "We look forward to working with Intarcia to leverage our peptide technology platform to create transformative new medicines."

About the Medici Drug Delivery System™
Intarcia's novel technology platform, the Medici Drug Delivery System, is a proprietary subcutaneous delivery system comprised of three unique technologies:

• A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more
• A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication
• A placement technology including proprietary tools designed to provide an optimal user experience

Once a drug is approved, a trained healthcare professional can place the small device in an in-office procedure. Once in place under the skin, water from the extracellular fluid enters the pump device at one end – by diffusing through a semi-permeable membrane directly into an osmotic engine – that expands to drive a piston at a controlled rate. This allows the drug within the pump to be released in a steady, consistent fashion at the other end of the device. Each osmotic mini-pump is designed to hold an appropriate volume of drug to treat a patient for up to a full year.

About ITCA 650
ITCA 650 is designed as a twice-yearly therapy for the chronic treatment of type 2 diabetes. The investigational therapy employs Intarcia's innovative technology platform, the Medici Drug Delivery System™. In its Phase 3 clinical trials for type 2 diabetes, ITCA 650 was evaluated while delivering a continuous and consistent drug therapy in a three-month initiation dose, followed by consecutive six-month doses. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist that is currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. All four of the global Phase 3 clinical trials for ITCA 650 in type 2 diabetes were successfully completed, and the New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) on November 21, 2016.  If approved, ITCA 650 would be the first and only injection-free GLP-1 receptor agonist therapy. Once-yearly mini-pumps at the 60mcg/day maintenance dose are also in development.

About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment and prevention outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. Delivering medicines just once- or twice yearly to prevent and/or chronically treat diseases holds potential to improve outcomes by improving effectiveness over time and by addressing real-world unmet needs around poor patient adherence and persistence rates that are high in the majority of chronic diseases. Intarcia is investigating multiple therapies, including combination therapies, for chronic diseases leveraging the convergence of novel medicines and the proprietary Medici Drug Delivery System™. Intarcia is developing a strong pipeline in important therapeutic areas, including: diabetes, obesity, autoimmune diseases, HIV, and other serious disorders.

About the California Institute for Biomedical Research, Calibr
The California Institute for Biomedical Research (Calibr) is an independent not-for-profit institute established in 2012 with the goal of accelerating the translation of basic research to new medicines that address unmet medical needs. Collaborations with researchers across the world expedite the translation of basic biomedical findings to new therapies, while enabling commercial partnerships are formed to bring these new medicines to the public. Value created from these activities is reinvested in preclinical and clinical research at the institute to further its mission. In October 2016, Calibr became a corporate affiliate of The Scripps Research Institute. For more information, see www.calibr.org.

Intarcia, Medici and their logos are registered trademarks of Intarcia Therapeutics, Inc.

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SOURCE Intarcia Therapeutics, Inc.

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