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Intarcia, Servier sign potential $1B deal for exenatide implant in type 2 diabetes

By Randy Osborne, Staff Writer

Intarcia Therapeutics Inc. sealed a potential $1 billion deal with Neuilly-sur-Seine, France-based Les Laboratoires Servier, centered on Intarcia’s phase III-stage ITCA 650 therapy for type 2 diabetes.

Servier gets exclusive rights to ITCA 650 outside the U.S. and Japan, while Intarcia retains full control of ITCA 650 in the U.S., and is looking for another partner in Japan.

Specifically, the arrangement brings $401 million in near-term payments, including $171 million up front and three early stage regulatory milestones totaling $230 million, followed by as much as $650 million that could be paid if development, regulatory and sales goals are reached.

If the phase III trials pan out fully, ITCA 650 would become the world’s first and only injection-free glucagon-like peptide-1 agonist given once or twice yearly in a small, matchstick sized mini-pump that can be placed sub-dermally by a doctor, nurse or physician’s assistant.

And, given commercial success, Boston-based Intarcia will also receive tiered net sales-related payments upon commercial success ranging from the low double digits up to the mid-30s as a percentage of sales of product supplied through the manufacturing and supply agreement.

Earlier this year, Intarcia reaped a hefty investment with a $200 million financing that includes $57 million from the Foresite Capital Fund II, a growth equity stash that jumped aboard the Intarcia bandwagon after getting the January peek at interim phase III data. Now, in a statement, Intarcia CEO Kurt Graves is touting the Servier deal as "one of the largest ex-U.S. partnering deals ever in the biotechnology industry.” Another batch of strong phase III results from the FREEDOM trials rolled out about a month ago, and Intarcia predicted a partnership would turn up in the second half of this year. (See BioWorld Today, April 2, 2014.)

Exenatide, developed as Bydureon by Amylin Pharmaceuticals Inc., of San Diego, for weekly injection – an improvement over Amylin’s earlier form of the drug, called Byetta – has proven its efficacy in type 2 diabetics, but compliance has been a problem. ITCA 650 gets around that. Intarcia proved that the implanted exenatide worked in people who had failed to reach their blood-sugar goals even after being switch between two or three oral medicines.

Under the terms, Intarcia and Servier will also share future global development-related investments for the life cycle management of ITCA 650, including new head-to-head superiority studies against other diabetes drugs and new combination regimens. Intarcia continues to lead the global ITCA 650 phase III trials, still on track to support filings around the world in the first half of 2016, and will also handle registration of ITCA 650 in the U.S. if the good results hold steady, while Servier will seek regulatory approvals outside the U.S. and Japan, with the support from Intarcia.

See the next edition of BioWorld Today for more on this story.