• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA accepts Intarcia’s NDA for diabetes drug-device combo

February 6, 2017 By Sarah Faulkner

Intarcia TherapeuticsFDA accepts Intarcia's NDA for diabetes drug-device combo said today that the FDA accepted its New Drug Application for the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The Medici drug-device combo delivers exenatide subcutaneously using a match-sized osmotic pump placed under the skin in an in-office procedure.

The subcutaneous delivery system uses technology to stabilize proteins, peptides, antibody fragments and other small molecules at or above human body temperatures for up to 3 years. Once the mini-pump is placed under the skin, water from extracellular fluid enters the device at 1 end, diffusing through a semi-permeable membrane into a salt osmotic engine and expanding to drive a piston at a controlled rate to release the drug within the pump from the other end.

Each mini-pump is designed to hold a volume of drug sufficient for a year’s worth of treatment.

When Intarcia submitted its NDA in November, the Boston-based company triggered a 3rd, $100 million milestone payment from the $300 million royalty financing put in place in the 2nd quarter of 2015. The milestone payment adds to the $215 million Intarcia raised in September.

In January, Intarcia and the California Institute for Biomedical Research said that the 2 groups will collaborate to develop a peptide therapeutic for patients with Type II diabetes and obesity. The drug will be derived from Calibr’s stapled-peptide technology platform, combined with Intarcia’s late stage investigational GLP-1 therapy and delivered using the Medici pump.

According to the deal, Calibr will receive an upfront grant of Intarcia equity and additional shares vesting over key development milestones. Calibr could also earn undisclosed cash payments after reaching predetermined regulatory and sales milestones, as well as tiered royalties on product sales.

Intarcia launched its Medici drug delivery platform in June last year, days after the company said it logged several milestones with pharmaceuticals maker Numab in their joint project to develop a drug-device combination for treating inflammatory and autoimmune diseases.

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Wall Street Beat Tagged With: Intarcia Therapeutics

IN CASE YOU MISSED IT

  • Medtronic to separate Diabetes business unit
  • Tandem Diabetes Care wins CE mark for Mobi insulin pump with Control-IQ+ technology
  • Glooko adds chief strategy officer to chief medical officer’s title
  • Cordis launches 10,000-patient registry for drug-eluting balloon
  • Senseonics opens $50M public offering, $25M private placement with Abbott

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS