Welcome to the future

Welcome to the future

Ask any physician, primary care or endocrinologist, to name the single largest obstacle to better patient outcomes. It won’t be the drugs available to treat diabetes. It won’t be the devices used to help patients better manage their diabetes. No the single largest obstacle to better patient outcomes is therapy compliance, getting patients to take their medications as prescribed. This sounds simple yet therapy is major issue for patients with diabetes. Numerous studies have shown that even insulin using patients sometimes skip insulin injections.

One would think it would be different for patients only taking oral medications but it isn’t. Studies have consistently shown that even for patients taking oral medications therapy compliance is a major problem.

This is why when asked during the recent round of diabetes conferences which drug and/or device excited Diabetic Investor the most, we consistently answered the micro pump from Intarcia Therapeutics.  The pump is implanted under the skin for up to a year and continuously delivers exenatide, which is more commonly known as Byetta. Yet unlike Byetta or any GLP-1 which must be injected the Intarcia micro pump once implanted delivers exenatide for a year.

Think about that just for a moment and what that means for the patient. Just by way of comparison look at the two most popular GLP-1’s – Victoza the once-daily GLP-1 from Novo Nordisk (NYSE:NVO) and Bydureon the once-weekly GLP-1 from AstraZeneca (NYSE:AZN).  Patients on Victoza inject 365 times per year, Bydureon patients 52; patients on the Intarcia system 0 zilch nada not one single injection.

What makes this system even better is that exenatide is a GLP-1 therefore there is little risk of hypoglycemia, plus the added benefit of weight loss. About the only thing missing from this story was how this system would perform against a popular diabetes drug like Januvia, that $6 billion blockbuster franchise for Merck (NYSE:MRK).  Well we got our answer yesterday when Intarcia released results from their Freedom-2 trial, a trial which compared their system to patients using Januvia over a 52 week period.

According to a company issued press release; “Patients treated with ITCA 650 60mcg experienced superior reductions in HbA1c versus those treated with Januvia® (sitagliptin) 100mg (-1.5% versus -0.8%; p<0.001). ITCA 650 60mcg produced significantly greater weight reduction versus patients treated with Januvia 100mg (-4 kg vs. -1.3 kg; p<0.001).”

To be quite honest Diabetic Investor felt that ITCA 650 didn’t have beat Januvia that if the system achieved comparable results this would be good news. The fact that ITCA 650 outperformed Januvia, by far the most widely prescribed branded diabetes drug, was a bonus. The reality is ITCA 650 compelling value proposition is the results seen in the trial will likely be duplicated in the real world as once implanted the patient doesn’t have to do anything. That’s exactly the point as the ITCA 650 solves the biggest issue standing in the way of better patient outcomes – therapy compliance.

Now these results as good as they are doesn’t mean that ITCA 650, once approved will be a surefire hit. Like any new drug there will be some initial physician resistance plus the usual business related issues like building a sales team, getting on formulary, etc. Yep those minor mundane issues of actually running a diabetes drug company rather than a drug development company.

Still the ITCA 650 is truly exciting as it makes therapy compliance a non-issue. For all the talk about once-monthly GLP-1’s or alternate insulin delivery systems the simple fact is these drug delivery systems require patient interaction. The only interaction the patient has with the ITCA 650 is getting it implanted that’s it. No daily or weekly injections, no need to count carbs or worry about a possible hypoglycemic event.  Even for patients on oral therapies life is easier as few patients just take one pill per day. Besides taking their diabetes medications most patients are also swallowing 3 or 4 other pills for conditions unrelated to their diabetes.

As we move ever closer to outcomes based reimbursement everyone has been running around searching for the magic bullet. Which tool, app, whiz bang device will transform the patient with diabetes from a disinterested bystander into patient engaged with their diabetes management. Drug companies for their part continue to search for drugs which require less frequent administration. Basically what everyone is looking for is the same thing – how to make diabetes management easier, how can we get these patients to stay compliant with their therapy regimen so they achieve better outcomes.

This is why Diabetic Investor sees the ITCA 650 and systems like it as the future of diabetes management for non-insulin using patients, by far the largest group of patients. The simple fact is once implanted the patient does nothing, for once their diabetes management fits into their lives and does not run their lives. The ITCA 650 has the potential not just to alter the diabetes drug business but have a tremendous and very positive impact on patient outcomes.

Welcome to the future everyone.