BOSTON—Biopharmaceutical company Intarcia Therapeutics Inc. and Servier have inked a strategic partnership for the development and commercialization of ITCA 650, a Phase 3 investigational therapy for the treatment of type 2 diabetes. Per the agreement, Servier will pay Intarcia an upfront payment as well as total potential development, regulatory and sales milestone payments totaling more than $1 billion. Intarcia also stands to receive ex-U.S./Japan tiered sales-related payments. Servier and Intarcia will share future global development-related investments for the management of the product, including head-to-head studies against existing therapies and novel combination regimens. Intarcia will continue leading global ITCA 650 Phase 3 trials as well as the therapy's potential U.S. registration, while Servier will pursue regulatory approvals outside of the United States and Japan, with Intarcia's support.
Kurt Graves, chairman, president and CEO of Intarcia, called the partnership is “one of the largest ex-U.S. partnering deals ever in the biotechnology industry,” and noted that “Servier brings a unique combination of financial strength, deep diabetes expertise with no competitive conflicts, and a track record of innovation and excellent performance in the EU and emerging markets. We placed high value on those factors and their partnering mindset when we made our final decision to select Servier over other major diabetes firms competing for months to be our partner.”
ITCA 650 is an injection-free GLP-1 agonist that is administered once or twice a year in a small, matchstick-sized miniature osmotic pump that is implanted subdermally. The active agent in ITCA 650 is exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. Should it secure approval, it would be the first injection-free GLP-1 therapy that could offer up to a full year of treatment from one administration.
“With continued success in the remaining Phase 3 trials, and additional outcomes studies planned to start next year, ITCA 650 represents the promise of a very important and totally novel therapeutic approach for patients with type 2 diabetes,” commented Robert Henry, M.D., professor of Medicine, in Residence, UC San Diego and chief of Diabetes & Metabolism VA San Diego Healthcare System. “ITCA 650 Phase 3 data show the potential to provide robust glucose reductions and weight loss together with potentially game-changing compliance and adherence that comes with just once- or twice-yearly dosing. Thus, ITCA 650 holds the potential to deliver the intended GLP-1 benefits earlier in therapy where injections don’t typically get used, while also addressing the poor compliance and adherence rates that all too often lead to poor control and treatment outcomes over time.”
“This disruptive injection-free GLP1 could reshape the treatment of type 2 diabetes in the very near future, and corresponds to our objectives for patient care in metabolic diseases,” Dr. Isabelle Tupinon-Mathieu, head of the Metabolism Innovative Center at Servier, said in a press release.
SOURCE: Servier press release