Intarcia received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for ITCA 650. We are in the process of responding to FDA’s requests and we remain confident and fully committed to ITCA 650. We, and all of our stakeholders, fully recognize the high importance it holds for bringing an urgently-needed solution to people living with poorly controlled type 2 diabetes (T2D).
Real-world outcomes data consistently demonstrate that the majority of patients living with T2D really struggle to adhere to chronic pills and injections. This is one of central reasons why diabetes remains a devastating public health crisis that is still spiraling out of control around the world. This is what fuels our unwavering commitment to bring forward our Medici technology and a new category of medicines that is fundamentally designed to address major unmet needs in diabetes and other serious chronic diseases.
It takes a purpose filled and tenacious kind of company to bring forth a disruptively simple solution for patients suffering from chronic diseases like type 2 diabetes and many others. Intarcia has made great progress in its journey so far. We’ve continued to push forward, we’ve set and met aggressive goals, and we will always aim to surpass them. In order to bring forth disruptive innovation we need to be comfortable when there is “no analog” to follow, and we need to know challenges will be frequent on our journey. When we meet these challenges, it is our mission and our tenacity of purpose for patients that will pull us through. We remain confident in the approvability of ITCA 650 and we look forward to working very closely with the FDA on next steps.
Intarcia remains in a strong fiscal position and is in the process of completing its Series EE round which has already raised over $600M. This and other financial milestones from our ex-US collaboration allow us to fully continue our goals for ITCA 650 and progress our pipeline.
I want to thank our passionate and resilient team at Intarcia for continuing to drive innovation forward, and to our valued stakeholders for their steadfast support and belief in our vision. I firmly believe that with every challenge, we are one step closer to reaching our goals.
Chairman, President and CEO
Intarcia Therapeutics, Inc.