Vivani Medical Mergers and Acquisitions Presentation Deck
Intarcia's ITCA 650 (6-month exenatide implant)
may be a relevant value analog for NPM-119
Value of long-term GLP-1 (exenatide) implant externally validated previously
2014 - Intarcia signed ITCA 650 deal with Servier (excluding US + Japan) $171M up-front, $880M
milestones, and double-digit royalties
Financings valued Intarcia as high as $4.0B (2017)
Intarcia's lead program was ITCA 650
2016 - Intarcia filed initial ITCA 650 New Drug Application (NDA)
2017 - FDA issued the first ITCA 650 CRL* (cited manufacturing concerns)
2019 - Intarcia re-submitted ITCA 650 NDA
2020 - FDA issued second ITCA 650 CRL (cited clinical safety and device constituent concerns)
2022 - After multiple dispute resolution actions, FDA denied Intarcia's request for public hearing
* CRL: Complete Response Letter -issued by FDA to identify NDA deficiencies
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