Intarcia Therapeutics 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.