Our NDA for ITCA 650 in Type 2 Diabetes Has Been Submitted to the FDA Seeking U.S. Marketing Approval: Winning for Patients Now a Significant Step Closer

NDA Submission Milestone also triggers third $100M payment to Intarcia from our 2015 Royalty financing. This adds to the $215M first close equity financing that closed mid-September. A second close of the financing is planned before the end of the 2016. We look forward to working with the FDA during the review and moving with a sense of urgency to prepare the organization to bring our first medicine to patients.

The amazing passion, talent and tenacity of our team – including our advisors, investors, and partners – and certainly including our investigators and patients - truly inspires me. For a company our stage and size to have accomplished the scale of tasks and milestones we have over the last 5 years with a totally disruptive platform and diabetes medicine is no small feat. To hit all our milestones with consistent and head-turning results is even more remarkable. Additionally, in parallel, we’ve been very fortunate to be able to keep the company private while strengthening our world class shareholder base and keeping the company very well capitalized for our future. Taking all this together – there is no analogue and we continue to chart a new path forward to maximize value. While we have much more to do, I want to thank and congratulate our team and all the stakeholders that have helped us get to this point and the bright future ahead.

Our company is built on a shared purpose and vision to build one of the most important companies in the chronic disease space. We now have the core foundation in place to open up a totally new pathway for delivering highly effective medicines than can be given just once or twice yearly. We’ve been playing the long game and I firmly believe that staying true to our vision, purpose and core values is what sets us up to attract and retain the best talent and face the next set of challenges and opportunities as we prepare to bring our first medicine to patients and advance our pipeline.

Submitting our New Drug Application (NDA) to the Food and Drug Administration for ITCA 650 in type 2 diabetes seeking U.S. marketing approval was a monumental task that culminated more than a decade of disruptive innovation across our proprietary technology platforms, manufacturing, and extensive clinical development. Somehow, the filing symbolically occurred on the heels of World Diabetes Day – a day that asks the world to urgently respond to the rapidly growing threat of diabetes with new thinking and totally disruptive solutions. How fitting that our submission was made in such close proximity to this call to action! Because what lies within that submission is a totally new approach to solving major unmet needs in T2D that haven’t been solved with the last 40+ T2D pills and injections. The 40+ T2D pills and injections approved over the last 10 years haven’t put a dent in the negative T2D treatment trends over the last decade. The fact that the majority of patients still aren’t treated to goal and/or adherent with their therapy speaks volumes about the need for something totally new and custom designed to address the chronic control and massive adherence issues that are holding back progress for millions and millions of patients. We look forward cooperating very closely with the FDA during the review and moving forward to help secure the promise of progress for appropriate patients in need.

Our trek towards commercialization continues now at rapid pace. It is considered by many to be daring for a tiny but entrepreneurial company to “go it alone” in the massive US pharmaceutical marketplace, even with an investigational drug that holds the potential to be disruptively innovate in one of the world’s largest disease categories – type 2 diabetes. To do that requires facing “Big Pharma” competitors who have large infrastructure, tons of cash, armies of sales reps, and a broad network of existing relationships in the category. We don’t underestimate any of those points, however, there are some fundamental things going for us. Perhaps most importantly are the following:

  • The Big Pharma “pill and injection model” of T2D management is clearly broken and fundamentally not improving the core treatment trends and outcomes in T2D. Said another way, if the last 40+ pills and injections for T2D haven’t improved the percent of people controlled and adherent with therapy over time, why would the next one be expected to change the trends? There is a crystal clear and urgent need for a totally different approach to therapy for patients in need.
  • Intarcia has stayed laser focused on the problems and unmet need trends that pills and injections have struggled to address in diabetes, and many other chronic diseases. We’ve designed our Medici technology and medicine/s to solve key unmet needs that no pill or injection has shown the ability to do. Our phase 3 data highlights the potential differentiation and advantages of our approach.
  • Truly disruptive companies and products never look like any analogue, they never attempt to look like any analogue. They also never attempt to operate like the entrenched incumbents that are all playing with the same products, strategies and tactics that are failing to improve overall outcomes for payers, providers and patients. Diabetes outcomes, lives lost, and tremendous costs are all going the wrong and quite horrific direction. More of the same isn’t the solution!
  • Last, we have the talent and we will bring in more to continue to execute with excellence and build a company that is built around a new way of treating chronic diseases. Every move we’ve made to date, and every action we will take once commercial, will aim to deliver a totally different customer experience and a totally different set of treatment outcomes that solves problems that pills and injections have failed to achieve. There is plenty of unmet need for us to solve and we can’t wait to start delivering and opening up a new way to treat chronic diseases.

Our privately held status is a very real opportunity and advantage at this stage of our growth. It allows us to focus completely on execution and fully commit to the critical decisions and actions we must make to drive our key strategies and high impact initiatives for growth. This is far more than a matter of style. We firmly believe it is a pathway to greater near-term success at a critical point in our strategic evolution towards a fully integrated and multi-product company. In fact, by remaining private and “going it alone” through the first year of launch, we can accrue powerful benefits. This includes our level of focus and prioritization on launch, our ability to stay gyroscopically on course and flexible, and our ability to maintain urgency in making timely decisions and taking reasonable risks. It also helps us sustain our lack of bureaucracy and avoid external distractions that don’t add value. There are strategic considerations as well and these are all powerful advantages that facilitate greater execution and success in the marketplace. Last but not least, in parallel, we will be advancing our Medici Drug Delivery System and our pipeline so that when we do go public we hold the promise of multiple game changing therapies in chronic diseases.

Our team is united in purpose: This is why we are so excited to unleash disruptively innovative medicines that hold unique potential for significant patient progress. Winning for patients is our number one goal!

By the end of 4Q, we look forward to our second close of our equity financing. This equity financing and our milestones over the next 2-3 years will put us in a very strong financial position and provide us with the capital to fund operations through the first year of the ITCA 650 commercial launch and pipeline progression.

Again, my heartfelt thanks to our Intarcia team, and my sincere appreciation to all our key stakeholders that have helped us accomplish our first NDA submission. It is a proud and important moment and we are inspired by what lies ahead!

Kurt Graves
Chairman, President and CEO
Intarcia Therapeutics, Inc.