Memorandum

Intarcia targets ITCA 650 (implantable exenatide mini-pump) resubmission for mid-2019 – December 20, 2018

Corporate update slates ITCA 650 filing for mid-2019; Highlights three recent leadership hires

Earlier this week, Intarcia published a 2019 update, announcing that ITCA 650 resubmission is planned for mid-2019. According to the company, Intarcia made significant progress toward resubmission in 2018 (including multiple meetings with FDA), following the September 2017 CRL for ITCA 650 (exenatide mini-pump), the company’s lead candidate. To our understanding, Intarcia has also been working to resolve the issues observed by FDA in an August 2017 Form 483. Given the company has been very quiet since the CRL, we’re glad to hear of this timing.

Doubtless, ITCA 650 is both a challenging regulatory proposition and an innovation that could improve patient experience further with GLP-1 agonists. The initial 1.3 million-page NDA contained multiple unique components: An implantable mini-pump requiring placement and removal kits plus temperature-stable components, as well as continuous release of a novel exenatide formulation. However, a matchstick-sized implant that delivers three to six months of GLP-1 could be a huge win for patients seeking convenience or who struggle with adherence, and we’re excited about the diversity it would bring to the class. As well, since Intarcia won’t have to work with PBMs (placement is done in the doctors’ offices), it should be able to create a price advantage as well.

Intarcia also emphasized recent leadership appointments across regulatory, medical, quality, and marketing. These include CMO and Global Head of Regulatory Affairs Dr. Fred Fiedorek (he is formerly of BMS and very highly respected), Global Head of Quality & Engagement Mr. Anders Vinthers, and Chief Marketing Officer and Metabolic Franchise Head Mr. Thane Wettig, formerly of Lilly. We imagine that all three have been instrumental in preparing ITCA 650 for resubmission and eventual launch. We see the GLP-1 market growing substantially and believe that ITCA 650 can drive further significant interest in the class, largely due to lack of discretion required.

 

-- by Ann Carracher and Kelly Close