Intarcia Therapeutics said today that it submitted a New Drug Application to the FDA for its injection-free ITCA 650 candidate, the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The ITCA 650 enables subcutaneous delivery of exenatide using a match-sized osmotic pump placed under the skin in an in-office procedure.
With the NDA submission, 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.
The Medici 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.
“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,” chairman, president & CEO Kurt Graves said in prepared remarks. “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 II 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 1 big step closer to our 1st 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,” Graves said.