Company poised to submit NDA for ITCA 650, progressing commercial readiness and advancing our pipeline: All signs of Company’s vision and purpose being realized – Winning for Patients!
In my six years since coming to Intarcia, there has been a remarkable refocus of our vision and purpose, and now that has been backed-up by very real traction – thanks to the passion and tenacity of our people, and the far-sightedness and growing strength of our investor base. We are not a Company where people come to pick up a paycheck. We are a team with an intensely shared purpose who lives by each and every one of our core values – Trust, Tenacity, Winning, Innovation, Caring, and Excellence – every day of every week. I’m immensely proud of our people and partners, and thankful to our investors. We are in the business of “Winning for Patients.” That is Intarcia’s first priority and continuing focus.
Simply put, our vision is to build a company with the real chance of becoming one of the most important biotech companies in the overall chronic disease space: A company opening a totally new pathway of delivering chronic medicines just once or twice-yearly that could transform outcomes, save lives, and dramatically improve costs and quality of life for millions of people globally who are plagued with some of the most challenging, deadly, and costly chronic diseases on the planet.
Toward that end, we’re going to have raised over $1.5 billion privately at attractive valuations, we’ve completed our 5,000+ patient Phase 3 program in record time, we’ve proven the potential advantages of our therapy vs. the largest-selling oral therapy on the market for type 2 diabetes, we’ve dramatically optimized our mini-pump procedure times and the overall customer experience to mainstream our Medici technology, we’ve acquired a company (Phoundry) and entered into additional pipeline collaborations (Numab) to fuel our pipeline, and we now plan to submit our first New Drug Application (NDA) to the United States Food and Drug Administration. Approximately one year after our NDA submission, we hope and expect to receive FDA marketing approval, allowing us to bring this potentially game-changing therapy to the type 2 diabetes patients who really need it.
Make no mistake. There is a huge and growing unmet need in the type 2 diabetes marketplace for the disruptively innovative solution we have designed. During the past 10 years, despite the approval of more than 40 new pills and injections for type 2 diabetes, there has been very little progress improving therapeutic outcomes of the majority of patients who unfortunately still remain uncontrolled, and many times non-adherent, with their pills and injections over time.
Right now, someone is dying from complications of diabetes every 6 seconds, or 14,000 people every day! And this doesn’t include the thousands and thousands of new cases of blindness, amputations, heart attacks, strokes, and end-stage renal disease that happens every day, as well.
Our vision is to turn the tide against serious chronic diseases like type 2 diabetes by overcoming what has long been an overwhelming set of obstacles around poor glucose control rates and exceedingly high non-adherence in the majority of patients around the world. 10-year trends around the mission critical metrics of glucose control and drug adherence rates over time have not improved, and for some segments of patients at risk, they’ve actually gotten worse – it is increasingly clear that traditional ways of delivering medicines in chronic diseases just don't overcome the real-world circumstances and challenges that the majority of patients experience over time. Our Medici Drug Delivery System™ is our proprietary approach and potential solution to these obstacles, and based on the successful Phase 3 clinical trial results shown by ITCA 650 using that technology platform, the Medici system holds great promise in type 2 diabetes, and other major chronic diseases we’re investing in as well for our future.
Our current equity financing should provide us with the capital to fund operations through the first year of the ITCA 650 commercial launch. This, in addition to over $500 million in milestone payments over the next 2-3 years, will enable Intarcia to remain laser-focused on execution and on bringing this potentially transformative investigational therapy to patients as a private company. By the end of 2018 we plan to have roughly a year of revenue from ITCA 650 to project forward from, and we also plan to have several pipeline assets in the clinic making progress and showing the combined value of our Medici Drug Delivery System™ and our therapeutic pipeline.
As always, our thanks and appreciation to all who share our vision and excitement for progress on behalf of patients, and to those who have supported and contributed to our efforts in this regard. Stay tuned!
Chairman, President and CEO
Intarcia Therapeutics, Inc.