Intarcia Therapeutics said today that French pharmaceutical independent Servier agreed to a deal to commercialize Intarcia’s implantable diabetes pump that could be worth some $1 billion.
Intarcia is developing ITCA 650, a matchstick-sized, miniature osmotic pump inserted subcutaneously to deliver the drug exenatide for 1 year.
The deal with Servier gives the French company exclusive rights to the drug-device combination except in the U.S. and Japan, according to a press release. Boston-based Intarcia said it plans to seek another partner in Japan to develop the device for that market.
Servier is slated to pay Intarcia $171 million up front, with another $230 million on the line as 3 "early-stage regulatory milestones" and a further $650 million in other "development, regulatory and sales milestones," the company said.
"As one of the largest ex-U.S. partnering deals ever in the biotechnology industry, our collaboration with Servier is yet another major milestone in a series of significant achievements over the last few years that are truly transformational for Intarcia and our stakeholders," Intarcia chairman, president & CEO Kurt Graves said in prepared remarks. "We are already the highest-valued private biotech company in history, with world-class investors, and now we are firmly set up to retain full control of the U.S. operations as we continue on our path to build a fully capable and disruptively innovative biotech company with a pipeline of game changing, once-yearly medicines. We are very pleased to partner with Servier, who shares our passion and vision for ITCA 650, and the goal of leveraging our technologies to open up a totally new way of delivering important GLP-1 therapy to patients with Type II diabetes."
Intarcia reeled in financing worth $210 million in November 2012, including a $160 million private placement and a $50 million debt round. Backers included existing investors New Enterprise Associates, New Leaf Venture Partners and Venrock and new investors The Baupost Group, Farallon Capital Management and "3 additional top-tier institutional investors based in Boston and New York," the company said at the time.
The deal with Servier also includes tiered royalty payments for sales made outside of the U.S. and Japan, according to the release. The companies will share the development costs for the ITCA 650 device, "including new head-to-head superiority studies against leading diabetes medications, as well as planned novel combination regimens," Intarcia said.
Results from Phase III pivotal trials, which Intarcia will continue to lead, are expected to be ready in time for regulatory filings in the 1st half of 2016, the company said. Intarcia will handle the U.S. regulatory application and assist Servier in seeking nods outside the U.S. and Japan, according to the release.