MESSAGE FROM THE CEO

Our Partnership with the Diabetes Community Begins with Our Vision for Progress

Our Company presented the very successful results of our first two phase 3 clinical trials at the American Diabetes Association’s 75th Scientific Sessions in Boston June 5-9. You might say it was the first time we officially put our vision for progress ‘on the record’ at America’s most preeminent diabetes meeting. It was wonderful to see the response of the diabetes community to our phase 3 clinical data, our disruptive drug delivery technology, as well as the potential pipeline opportunities ahead. Now that we have a more visible presence within the broader diabetes community, we intend to increase our engagement and collaboration so that together we can determine how to best capture the full clinical and health-economic benefits of our investigational therapy ITCA 650 for patients, payers and providers.

Intarcia fully and proudly engaged at the 75th ADA Scientific Sessions in Boston

This year was our first significant presence during the American Diabetes Association’s Scientific Sessions, which took place right in Boston – the hometown of our corporate headquarters. In fact, our headquarters is a quick walk from the convention center. It was a great opportunity for us to support the excitement of the estimated 18,000 participants as part of the “Innovation District” in the Seaport area of Boston.

It was also very timely that just the night before the opening day of the diabetes sessions, June 4th, our Company was named a 2015 Entrepreneur of the Year in a very competitive process organized by EY. We were honored by this distinction, and it added a welcome boost of energy just before our engagement at ADA.

Dr. Julio Rosenstock delivered the Oral Presentation of the placebo-controlled phase 3 results for ITCA 650 before a full room (photo below left). The presentation was received very well by attendees, and it represented the first public presentation of results from a large phase 3 trial – an important milestone for the company and our potentially game changing technology.

The Poster Session dealing with High Baseline patients in the open-label phase 3 trial presented by Dr. Michelle Baron (photo on right) and Dr. Bob Henry showcased the clinical results of ITCA 650. Clinical progress in this high-risk group is very noteworthy.

Separately, we were very gratified by audience response to our technology and business development exhibit where potential partners and investigators observed and learned about our investigational technology (see photo of the demonstration exhibit booth below). We generated significant interest among scientists in industry, academics and government who are developing new compounds that could show promise for use in combination with our novel technology.

A surprisingly equally satisfying moment at the ADA was our Product Theater that showcased the real facts about non-adherence and its costs in type 2 diabetes (photo lower left). The large area had overflowing attendance, and the response by many was a frank acknowledgement that the scope and severity of non-adherence has been significantly underestimated and misunderstood. The information was considered valuable and worthy of a larger effort to better inform the practicing medical community.

Typically I wouldn’t mention a celebration event, but our closing celebration for all of Intarcia’s activities at the ADA Scientific Sessions this year warrants attention. We invited our closest stakeholders who were in town, and it was very inspiring to see how the size and enthusiasm of the crowd have grown. There is a crescendo of both excitement and engagement that is clearly taking place, and it tracks with our forward momentum. It took place at the Institute of Contemporary Art (photo above right).

We were delighted to have Red Sox slugger and Boston-based philanthropist David Ortiz join us to help ‘up-the-game’ in the fight against diabetes. “Big Papi,” as he is known to his fans, has diabetes in his own family, and understands that because it is an epidemic, everybody in the room had a friend or family member touched by this disease. He served as an inspiration to us in his own career as he “Swings for the fence” every time he plays for the Red Sox … Just as Intarcia will “Swing for the fence” for patients with diabetes, and eventually with other major chronic diseases and disorders as we unfold our pipeline.

With our first full participation in the annual Scientific Sessions of the American Diabetes Association, I believe both our Company and our late-stage investigational product ITCA 650 have “come of age.” This new scale in our endeavors, the stakes involved and the accountabilities we now embrace, is generating an amazing amount of excitement within our Company. As we forge ahead, the climb will get steeper and more complex. Good! We’ve been waiting for it. It’s why we are here, and it’s the only way to the summit and beyond.

Three possible paths to more effective management of type 2 diabetes

I’d like to share three particular themes I took away from discussions with a number of academic and clinical thought leaders who were here for the Scientific Sessions in Boston, but also from data presented at several events at the convention. These clinical themes stand out to me because they likely represent some of the highest impact approaches towards more effective management of type 2 diabetes, and therefore ought to receive greater prioritization and focus so we can change the status quo trends and huge unmet needs in diabetes:

  1. Early effective control usually creates a longer lasting clinical benefit than either a “wait-and-see” approach, or a hesitant step-wise process that slowly tries to nudge patients toward control of HbA1c levels.  Many times a drawn out series of steps that fall short and fail repeatedly over time are tougher to overcome later and the disease advances as well. Gaining early and effective control, and early successes that reinforce progress for patients seems in order. Many experts point out that an early push for success is also how many other diseases are managed more effectively these days, but these improvements have not yet made it to diabetes. Five to ten year trends still show that 60-70% of T2D patients are not at goal, and even more have poor adherence and control over time. These fundamental trends need to change.
  2. Non-adherence with drug therapy in type 2 diabetes is extremely prevalent, and while recognized by most thought leaders in the diabetes community, it is not well recognized by many primary care physicians. Moreover, it is very hard to change behaviors in patients that have poor adherence.  As a result, poor adherence and control over time continues to have devastating effects on outcomes for millions of patients and their payers and providers. New approaches to effectively reduce or eliminate non-adherence are in order. Wherever non-adherence flourishes, so does impaired glycemic control and the consequences associated with advanced disease. This must be addressed.
  3. New combination therapies are being evaluated, and early data suggest that all combos are not ‘created equal.’ The choice of combination therapy has to be tailored to clear goals. The data emerging on different combo regimens show that regimen selection can directly impact A1c control, adverse events, adherence rates, and thus therapeutic outcomes over time. Thought leaders believe the most exciting combinations will optimize benefit/risk with a focus on maximizing A1c reductions and weight loss while also minimizing the risk of hypoglycemia and other AEs. These benefits, as well as the availability of more convenient methods of treatment, will help patients stay persistent with therapy over time. 

When you combine these three clinical themes against the stark fact that HbA1c levels of 60%-70% of T2D patients are inadequately controlled, it is clear that improvements in treatment are desperately needed. We are very encouraged that in the next few years, ITCA 650, our late stage investigational therapy, could become an important part of a solution for appropriate patients. We are on track to complete our remaining phase 3 trials for ITCA 650 later this year, so we should meet our projected submission for regulatory filings in the first half of 2016. Meanwhile, we also are readying extensive training and education programs that will help prepare providers and their staff for a new way of delivering medicine just once or twice yearly. We are focused on helping ensure a consistently optimal customer experience from the very beginning, should our product be approved as planned.

Diabetes deserves to be an extremely high priority – but it’s not!

One last critical point deserves our full attention. After engaging in all the energy and passion of the activities at this year’s American Diabetes Association Scientific Sessions, the terrible irony is realizing that: “What happens at ADA stays too often in ADA.” The mainstream media isn’t really covering the news, issues and advances nearly enough. We are at risk of allowing a perceived laissez-faire attitude develop toward diabetes – despite it being a very clear and present danger to hundreds of millions of people. Diabetes needs to be better prioritized, better respected, better communicated, and better addressed.

I join other leaders and advocates that believe a timely and large-scale course correction is needed in diabetes. Diabetes is not the chronic disease that we can afford to let spin out of control silently in the background. It is the chronic disease everybody needs to know more about because it is an epidemic with massive consequences for patients and our nation’s healthcare system as a whole, if we don’t rise up and take aggressive action to get it under better control. If not addressed earlier and more effectively it will have terrible and very costly effects. At its current rate of growth, the costs alone will become completely unaffordable for all of us in the next 20 years (projected to be well over $3 trillion every decade in the U.S. alone according to United Healthcare). But far too few people, including government leaders, seem adequately aware or concerned compared to the heightened focus being given to other diseases.

As an example, a respected journalist recently summed up the coverage disparity at ADA by saying: “Cancer is Hot, and Diabetes is Not.” That was a headline right after ASCO, the nation’s largest oncology meeting, and just before ADA kicked off. The sad truth is, he’s got a point. While the press covers oncology conferences and orphan diseases, both of which are important, diabetes languishes by comparison. Diabetes is not presently a “hot” topic in health news being reported to the American public. Yet it is projected to potentially impact 1 out of every 3 Americans in the not too distant future.

This lack of focus on diabetes is unacceptable, because it doesn’t highlight the facts and the unmet needs, nor the innovations and progress that is possible if we work together to get it under better control. Intarcia would like to help catalyze and participate in bold initiatives to instill a greater sense of urgency to meet the broader challenges facing us around the world with type 2 diabetes.

Intarcia’s motto is “Time 2 Disrupt!”

These are exciting times for all of us at Intarcia and we remain focused on challenging and disrupting the “status quo” trends and unmet needs in type 2 diabetes. These are times of great opportunity and challenge as we strive to improve outcomes and bring our pipeline of disruptive innovations forward to patients, payers and providers.

I want to thank the talented people of our Company, our world-class investors, our dedicated business partners, and most especially all the amazing people of the diabetes community. We look forward to much broader and impactful forms of collaboration going forward so we can better serve our mutual goals of noteworthy progress against diabetes. Our passion has been and will always remain focused on winning on behalf of patients.

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





























The Red Carpet Leading to ADA's 75th Scientific Sessions
The long path to present our clinical data at this year's ADA is now behind us. Ahead we will collaborate even more with the diabetes community to determine how best to achieve the progress possible with ITCA 650.