Intarcia Therapeutics has closed a $225 million financing in exchange for 1.5% of future global net sales of ITCA 650, a novel once or twice yearly exenatide pump. Investors have the option to convert their royalty interests into common stock in future.
Intarcia has raised over $1 billion since its founding. That includes a $225 million round today, a $50 million round in 2007, a $210 million round in 2012, a $200 million round in 2014, and $171 million upfront from Servier in 2014. Servier has rights to ITCA 650 outside of the U.S. and Japan.
ITCA 650 is a matchstick sized mini-pump which can be placed under the skin to release exenatide. Exenatide is a GLP-1 analog for the treatment of type 2 diabetes. A once-weekly injection has been approved under the trade name Bydureon.
ITCA 650 consists of a cylindrical titanium alloy reservoir. Once placed under the skin, water diffuses through a semi-permeable membrane into a salt osmotic engine at one end, which forces the drug to be steadily released at the other end. One of the main technical challenges was how to maintain the stability of exenatide at human body temperatures over long periods of time.
Intarcia is currently testing ITCA 650 in a Phase III program called FREEDOM. The company has completed two of the four Phase III trials in the FREEDOM program. Both the FREEDOM-1 and FREEDOM-1 HBL studies met their primary and secondary endpoints.
In the FREEDOM-1 trial, a mean reduction of 1.4% to 1.7% in HbA1c was observed across the majority of patients. The second trial, FREEDOM-1 HBL, showed a reduction of 3.4% in HbA1c in patients with very high baseline HbA1c levels (10-12%).