Intarcia Submits New Drug Application (NDA) to FDA for U.S. Marketing Approval of ITCA 650 in Type 2 Diabetes
- The NDA submission reflects more than 10 years of innovation and clinical development of ITCA 650 to respond to pressing unmet needs in type 2 diabetes.
- ITCA 650 is the first investigational drug to use Intarcia's disruptive Medici Drug Delivery System™ to deliver chronic medicines just once or twice-yearly.
- The ITCA 650 NDA submission triggers the third $100 million milestone payment to Intarcia from the $300 million royalty financing put in place in 2Q 2015. This $100 million milestone adds to the $215 million committed in the first close of equity financing just 8 weeks ago. A large second close is planned this quarter.
- Intarcia looks forward to working closely with the FDA during the review of the ITCA 650 NDA, and moving with urgency to prepare for the Company's next growth phase: bringing ITCA 650 to the market and to patients in need.
BOSTON, Nov. 21, 2016 /PRNewswire/ -- Intarcia Therapeutics, Inc. announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ITCA 650 for the treatment of type 2 diabetes (T2D). The NDA submission was made in close proximity to World Diabetes Day, and during National Diabetes month in America – two annual events that remind us that type 2 diabetes is one of the largest and fastest-growing public health crises in the world. If approved, ITCA 650 would become the first and only injection-free glucagon-like peptide-1 (GLP-1) receptor agonist therapy. ITCA 650 provides consistent and continuous subcutaneous delivery of exenatide via an osmotic mini-pump placed just under the skin in a simple in-office procedure that only takes a healthcare provider a few minutes to perform. ITCA 650 mini-pumps were given with a 20mcg/day three-month introductory dose and then followed by a 60mcg/day six-month maintenance dose. Twelve-month mini-pumps at the 60mcg/day maintenance dose are also in development.
"It's very exciting for us to submit our NDA in close proximity to World Diabetes Day – a day created to drive for new and innovative solutions that respond to the rapidly growing unmet needs and threats facing hundreds of millions of patients and their doctors and payers around the world," said Kurt Graves, Chairman, President and CEO of Intarcia. "During the past decade over 40 new pills and injections were approved for diabetes, however, the scary reality is that the majority of patients with type 2 diabetes still have poor glycemic control and poor adherence to their pills and injections over time. These trends and the alarming amount of diabetes complications, costs, and lives lost on a daily basis have to be addressed with a real sense of urgency. The crisis in front of us is what inspires us and drives us to innovate and disrupt the way society currently thinks about trying to control chronic diseases with pills and injections. Instead of working on yet another incremental pill or injection, our mission is to open up a totally new and disruptive pathway of delivering effective medicines just once or twice-yearly with built in compliance and adherence. I want to sincerely thank everyone dedicated to this mission with us. We are one big step closer to our first medicine making it to patients and we hope and trust we will have much to celebrate and give back to the diabetes community around World Diabetes Day next year, and for many years to come."
About the FREEDOM Clinical Trial Program FREEDOM is a global clinical trial development program made up of four Phase 3 studies of ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes (T2D). The FREEDOM-1, FREEDOM-1 HBL, FREEDOM-2, and FREEDOM-CVO trials were successfully completed and met all primary and secondary endpoints. Results include demonstrating superior efficacy versus placebo and versus market leader, Januvia®. The overall FREEDOM program enrolled more than 5,000 subjects at over 500 clinical investigation sites in more than 30 countries to support U.S., EU and ROW regulatory filings.
About ITCA 650 ITCA 650 is designed as a once or 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. If approved, ITCA 650 would be the first and only injection-free GLP-1 receptor agonist therapy.
About 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 for a simple, quick and highly reliable user experience
Once trained, physicians, physician's assistants, or nurse practitioners can quickly and simply 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 a salt 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 and beyond.
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. Intarcia's 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, autoimmune, and other serious diseases. For more information on the Company, please visit www.intarcia.com.
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