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.
A qualified physician, nurse or physician’s assistant can place ITCA 650 in a simple five-minute procedure in a doctor’s office.
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.
Intarcia grants Servier exclusive rights to ITCA 650 in ex-U.S./Japan territories; Intarcia retains full control of ITCA 650 in the United States and plans another partner in Japan.
Intarcia upfront and potential milestone payments total more than $1B; Includes $401M near-term with an upfront payment of $171M and three early stage regulatory milestones of $230M; with $650M in additional development, regulatory and sales milestones.
Intarcia will receive tiered net sales-related payments with commercial success ranging from the low double digits to the mid-30s as a percentage of sales of product supplied through the manufacturing and supply agreement.
Both parties will co-invest in an additional manufacturing site outside the U.S.
Both parties will share global development costs on new superiority studies and combination regimens planned and agreed upon.
Servier will wholly fund any territory-specific trials required for marketing approvals.
For further deal information visit Current Agreements (subscription required)
Report: Top 50 Big Biotech Partnering and M&A Deal Trends