Currently Viewing:
Newsroom
Currently Reading
Intarcia Forming Collaborations While FDA Reviews ITCA 650
January 19, 2017 – Mary Caffrey
What's as Bad for the Heart as Obesity? Try Depression
January 17, 2017 – Mary Caffrey
Nearly Half of New Drugs Approved in 2016 Were Orphan Drugs
January 17, 2017 – Laura Joszt
Safety of Januvia in Oldest Patients With Diabetes Confirmed in Study
January 16, 2017 – Mary Caffrey
This Week in Managed Care: January 13, 2017
January 13, 2017
AJMC® in the Press, January 13, 2017
January 13, 2017 – AJMC Staff
CMS Takes Step Toward Coverage of Continuous Glucose Monitors
January 13, 2017 – Mary Caffrey
Public Health Experts Want to Ban Britain's Coca-Cola Christmas Truck
January 12, 2017 – Mary Caffrey
Council for Diabetes Prevention Selects Board, Focused on Medicare Launch of DPP
January 11, 2017 – Mary Caffrey

Intarcia Forming Collaborations While FDA Reviews ITCA 650

Mary Caffrey
Observers have called the mini-pump, which continuously delivers exenatide, a "game changer" because it has the potential to overcome medication adherence in the patients who are most resistant to treatment.
Intarcia Therapeutics, which entered a new chapter in November when it filed its new drug application (NDA) for a novel diabetes treatment, has continued to pursue collaborations around its innovative mini-pump technology.

This month, Intarcia announced a licensing deal with Calibr to deliver a “next-generation” combination product to treat diabetes and obesity. This came on the heels of an announcement on December 29, 2016, that the company had raised an additional $206 million in financing that included a relationship with the Bill & Melinda Gates Foundation to use its technology to create a new therapy to prevent HIV.

Filing the NDA for ITCA 650, which delivers a continuous, microscopic dose of exenatide for patients with type 2 diabetes (T2D), marked a milestone in more ways than one. Not only did Intarcia present the fruits of its 10-year effort to change the treatment paradigm in chronic disease, but the filing also triggered a $100-million milestone payment, based on 2015 financing.

Intarcia’s matchstick-size mini-pump, which delivers a continuous, microscopic dose of exenatide, has drawn attention at successive meetings of the American Diabetes Association (ADA), both for the glycated hemoglobin (A1C) reductions seen in trials and for a delivery system that observers have called a “game changer.” The prospect of overcoming poor medication adherence rates in T2D with a subcutaneous pump that can be replaced just once or twice a year has drawn large crowds to sessions and to Intarcia’s demonstration booth the past 2 years at ADA.

Results from trials have shown that ITCA 650 produces larger A1C improvements than sitagliptin—a top-selling T2D therapy—and Intarcia announced in May 2016 it had achieved the cardiovascular safety outcomes needed for FDA approval. Full results of that trial, FREEDOM-CVO, have not yet been presented. That same month, Intarcia also announced the branding of its drug delivery system, Medici, which includes the subcutaneous mini-pump, the placement technology, and the technology to keep therapies stable at or above human body temperatures.

The collaboration with California Institute for Biomedical Research (Calibr) surrounds Calibr’s stapled-peptide platform technology. It calls for Intarcia to develop this therapy in combination with exenatide—the active agent in the ITCA 650—through use of the Medici system. “We are committed to disruptive innovation leveraging our proprietary Medici Drug Delivery System, and we now have several combination products in our pipeline that we believe can uniquely optimize delivery in a once- or twice-yearly mini-pump,” said Intarcia CEO Kurt Graves in a statement.

The collaboration with the Gates Foundation calls for Intarcia to develop a once- or twice-a-year therapy that would stop the spread of HIV, which the foundation’s CEO, Sue Desmond-Hellman, described as a “vital need.”

"We feel optimistic about our partnership with Intarcia and the prospect of an implantable prophylactic device that could make a world of difference for people most in need,” Demond-Hellman said.

 
Copyright AJMC 2006-2019 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up