Date: 2014-11-11
Type of information: Development agreement
Compound: ITCA 650 (exenatide, delivered continuously once or twice yearly through a matchstick-sized, subcutaneous osmotic mini-pump)
Company: Intarcia Therapeutics (USA - MA) Servier (France)
Therapeutic area: Metabolic diseases
Type agreement: development commercialisation
Action mechanism: ITCA 650 (a once or twice-yearly continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia\'s proprietary technology platform involving a matchstick-size, miniature osmotic pump that is placed sub-dermally to provide continuous and consistent drug therapy, and the company\'s proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time. A qualified physician, nurse or physician\'s assistant can place ITCA 650 in a simple five-minute procedure in a doctor\'s office. Exenatide, the active agent in ITCA 650, is 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.
Disease: type 2 diabetes
Details: * On November 11, 2014, Intarcia Therapeutics announced the successful start of a strategic partnership with Servier outside the United States and Japan, to develop and commercialize ITCA 650, Intarcia's phase 3 investigational therapy for the treatment of type 2 diabetes. If successful in its remaining phase 3 trials, ITCA 650 would become the world's first and only injection-free GLP-1 agonist given just once or twice yearly in a small, matchstick sized mini-pump placed sub-dermally. Intarcia recently announced top-line results showing positive primary endpoints from two of its four phase 3 clinical trials. "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. 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,\" said Robert Henry, M.D., Professor of Medicine, in Residence, UC San Diego and Chief, Diabetes & Metabolism VA San Diego Healthcare System.
Financial terms: Under the agreement, Intarcia is to receive an upfront payment and total potential development, regulatory and sales milestone payments totaling more than $1 billion. Intarcia will also receive ex-U.S./Japan tiered sales-related payments. The parties will also share future global development-related investments for the life cycle management of ITCA 650, including new head-to-head superiority studies against leading diabetes medications, as well as planned novel combination regimens. Intarcia will continue to lead the global ITCA 650 phase 3 pivotal trials, which are on track to support global filings in the first half of 2016. Intarcia also will continue its lead role in the potential registration of ITCA 650 in the U.S., while Servier will seek regulatory approvals outside the U.S. and Japan, with the support of Intarcia.
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