Intarcia and Calibr Announce Collaboration and In-Licensing Deal Aimed At Delivering a Next Generation Combination Product For Diabetes & Obesity

Intarcia and Calibr Announce Collaboration and In-Licensing Deal Aimed At Delivering a Next Generation Combination Product For Diabetes & Obesity

Collaboration aims to develop a novel peptide therapeutic derived from Calibr's Stapled-Peptide Technology Platform that can be combined with ITCA 650, Intarcia's late stage investigational GLP-1 therapy for Type 2 Diabetes.

The Calibr deal expands Intarcia's existing combination product strategy and pipeline that is targeting diabetes, obesity and other potential indications.

Intarcia's Medici Drug Delivery SystemTM will be leveraged to optimize the combination therapy and then deliver it in a once- or twice-yearly mini-pump.

Boston, MA, and San Diego, CA, January 9, 2017 Intarcia Therapeutics, Inc. and the California Institute for Biomedical Research (Calibr) today announced a strategic research collaboration focused on the development of a novel peptide therapeutic leveraging Calibr's Stapled-Peptide Platform Technology. Intarcia plans to develop and administer this novel therapy in combination with Exenatide (a GLP-1 receptor agonist and active agent in Intarcia's ITCA 650 product), by leveraging its proprietary Medici Drug Delivery SystemTM.

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 SystemTM 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 outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. Delivering medicines for six-month periods of time, and potentially for up to a year and beyond, may improve outcomes by addressing patient adherence and persistence issues with prescribed drug therapies, which are very poor in most chronic diseases. Intarcias drug development expertise and competitive edge are brought to life within the Medici Drug Delivery System , the innovative science and technology platform from which Intarcia plans to launch its pipeline of disruptively innovative drugs. Intarcia continues to research and develop treatments utilizing the Medici Drug Delivery System for major chronic disorders such as diabetes, obesity, HIV prevention, autoimmune, and other serious diseases. For more information on the Company, please visit www.intarcia.com. Follow us on Twitter @intarcia.

About the California Institute for Biomedical Research, Calibr

The California Institute for Biomedical Resea

LINK:	http://www.scripps.edu/news/press/2017/20170109intarcia_calibr.html...
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