November 12, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Intarcia Therapeutics, Inc. today announced the formation of a strategic partnership with French biopharma Servier to develop and commercialize outside the U.S. and Japan Intarcia’s Phase 3 investigational therapy for the treatment of type 2 diabetes, referred to as ITCA 650.
Under the agreement, Boston-based Intarcia will receive $171 million upfront and $230 million for three early stage regulatory milestones. Additional development, regulatory and sales milestones could bring the entire deal to $1 billion in total.
The two companies will share the cost of running studies that compare ITCA 650 to other leading diabetes treatments. Intarcia will continue to lead the current phase 3 trials of ICTA 650 and the effort to seek regulatory approval in the U.S., while Servier will spearhead the efforts to seek approvals outside the U.S. and Japan. In the announcement, Intarcia stated that regulatory approval filings for ICTA 650 could be submitted as early as the first half of 2016.
According to the Intarcia CEO Kurt Graves, this agreement is “one of the largest ex-U.S. partnering deals ever in the biotechnology industry.” He said in a statement from Intarcia, “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.”
The deal is based on the recently released successful top-line results of two of the four Phase 3 clinical trials evaluating ITCA 650. The active ingredient of the ITCA 650 therapy, exenatide, is an approved glucagon-like peptide-1 (GLP-1) receptor agonist. Currently exenatide is administered via a twice-daily or once-weekly self-injection therapy. The innovation of the ITCA 650 device, which is a matchstick-sized mini-pump placed sub-dermally, is its design to deliver a full year of treatment from a single placement. In addition, the placement of ITCA 650 can be done in a five-minute procedure at a doctor’s office. If approved, ITCA 650 would be the first injection-free GLP-1 therapy that could deliver up to a full year of treatment from a single placement.
The device has 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,” Robert Henry, chief of Diabetes & Metabolism VA San Diego Healthcare System was quoted as saying in the press release.
Graves explained that Intarcia chose Servier, an independent French pharmaceutical research company, as its partner in going global with ITCA 650 because of Servier’s “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.”
Pascal Touchon, vice president of Business Development and Scientific Collaboration at Servier, stressed that Servier will bring “extensive know-how and experience in [the] field” of innovative treatments for type 2 diabetes to the partnership. He emphasized that the two companies will collaborate closely to bring ICTA 650 to market because they “share a common vision and urgency” to find effective treatments for patients with type 2 diabetes.
