This is the future

This is the future

One of the most confounding aspects of diabetes is the daily demands placed upon the patient. This is not limited to monitoring glucose levels, eating healthy, exercising regularly or maintaining a healthy weight. The daily grind of diabetes management also involves being adherent to the prescribed therapy regimen. For patients using insulin this means either injecting, pumping or inhaling insulin once or several times per day. For patients using oral medications this typically involves swallowing multiple pills each day. Keep in mind that the typical patient with diabetes is not just taking medications to manage their diabetes they are taking additional medications to manage other conditions. It’s not uncommon for a patient with diabetes to take 3 or 4 additional medications on top of the medications they use to manage their diabetes.

Ask any physician what is the biggest obstacle facing the patient, what stands in the way of achieving better outcomes and the likely answer will be medication adherence. A patient being compliant with their therapy regimen is the key to better outcomes. This trumps the need for newer or better therapies. This goes beyond making diabetes more affordable, although some could argue that affordability does impact compliance. Yes newer and better therapy options would be nice but are meaningless if not taken as prescribed.

This quest to get patients to be compliant with their therapy regimen has created some interesting approaches. Today many of these efforts center on mobile technology using apps or text messages which remind the patient it’s time to take their pills. Diabetic Investor has long argued that education is the most effective tool at getting patients to be compliant, a claim backed up by numerous studies. Yet even with all these efforts the fact remains that medication adherence is a major issue.

It is for this reason that Intarcia Therapeutics was able to raise an additional $225 million to continue their development and commercialization of an implantable pump that delivers a year’s supply of exenatide, a drug which is now injected into the body. Exenatide a GLP-1 is more commonly known as Byetta which was developed by Amylin and now owned by AstraZeneca (NYSE:AZN). As we have seen recently with the introduction of Bydureon, also from Astra, Tanzeum from GlaxoSmithKline (NYSE:GSK) and Trulicity from Lilly (NYSE:LLY) – all injected just once weekly – the GLP-1 category continues to grow.  The category also includes Victoza from Novo Nordisk (NYSE:NVO) which is injected once daily and has performed above expectations and now has the additional indication as a treatment for obesity.

What makes GLP-1 therapy so compelling is not just how effective it is but also the simplicity of the therapy. Unlike patients using insulin patients using a GLP-1 do not need to regularly monitor their glucose levels as all the GLP-1’s are dosed at pre-set levels. The patient’s glucose levels don’t correlate to how much is taken. GLP-1’s also offer two additional benefits – there is little risk of hypoglycemia plus at minimum they are weight neutral and more than likely as numerous studies have shown they help the patient loss weight.

It’s no accident that GLP-1 usage is increasing and will continue to increase with these new once-weekly versions now on the market. This is something Diabetic Investor predicted long ago since the time Byetta, taken twice daily, came on the market. The simple fact is the fewer times a medication needs to be taken the better.  A fact that just does not apply to injectable therapies such as insulin or GLP-1 but also to oral medications. Studies have proven the fewer pills the patient needs to take the more likely it is they will be compliant.

Still the fact remains that patient compliance is a major issue, that even with these newer drugs which are taken less frequently we have yet to see a noticeable improvement in outcomes. This is also why Diabetic Investor believes that the Intarcia pump will be the first of many implantable options and not just for drug delivery but also for glucose monitoring. Yes there was a time long ago when Diabetic Investor was opposed to almost anything implantable based on the sole fact that if something goes wrong, should the device fail, it must be extracted from the body.

Now this does not mean the Intarcia pump is fool proof. As much as technology has improved over the years one indisputable fact remains, medical devices no matter how well manufactured, are going to fail they are going to malfunction. This is just the nature of the beast.

The reasons Diabetic Investor has changed our tune on implantables is two-fold – the technology is vastly improved plus implantables are simple. Think about this from not the perspective of anyone else but the patient with diabetes, how much easier their lives will be with these devices. As we have noted many times the vast majority of patients with diabetes want to live their lives with their diabetes and not for their diabetes. They crave diabetes management options which make their lives simpler not more complex. Most of all they would like nothing better than not to have think about their diabetes management.

Unfortunately for Type 1 patients this is not yet possible as the closet they can come is insulin pump therapy. Even with the quest to develop a true artificial pancreas we remain unconvinced that this will liberate patients with Type 1 from the daily grind of managing their diabetes. We feel this way not because as we advance towards this goal insulin pumps and continuous glucose sensors won’t get better, they will. We feel this way because when something goes wrong, when the system malfunctions the patient can end up dead. Unlike a GLP-1 insulin can be lethal when not properly administered.

Yet for the millions of patients with Type 2 diabetes the Intarcia pump will be nirvana, almost heaven on earth. Think about this for a moment, after one visit to the physician’s office to have the pump implanted, that’s it, the patient no longer has to do anything. No more shots, no pills to take. They can live their lives like a normal person and not have to think about managing their diabetes. What could be simpler, what could be more liberating? Yes of course there is the worry the system could malfunction but at least if it does this malfunction won’t lead to a lethal result.

To Diabetic Investor next to a cure, implantable technologies are the best thing going in diabetes for no other reason is they make diabetes management simple, they make the patient’s life better and less complex. For all the hype surrounding interconnected diabetes management, the artificial pancreas or stem cell research implantable technology has the potential to revolutionize diabetes management, to be a true game changer.

That being said this the road ahead for Intarcia won’t be an easy one for as we have seen before the structure of this wacky world often times stands in the way or slows down progress. The first hurdle obviously is getting the pump approved by the FDA, an agency not exactly known for being forward thinking. Next comes the task of getting the system paid for, which as we have seen many times is nearly as difficult and maddening as dealing with the FDA. Then comes the equally difficult task of running the company. As we have said many times in the insulin pump space the real talent is not developing a pump, the real talent is running an insulin pump company. Although the Intarcia pump delivers a GLP-1 and not insulin the same rule applies. Diabetic Investor has seen too many companies with great ideas, great drugs or great devices that failed because they were not well managed.

However this is one time we don’t see a high level of physician resistance something normally seen when any new drug or device comes on the market. Again as we have noted physicians tend to be a rather conservative bunch loath to embrace new options until they have been tested. This is one reason has it has taken this long for the GLP-1 market to mature. Physicians knew of the many benefits of the therapy but wanted to see real results for themselves. Along with greater payor acceptance combined with once-weekly dosing options is what’s driving the GLP-1 market today.

By the time the Intarcia pump gets here, which according to the company will not be until late 2017, physicians will likely view the system as a natural evolution. They will not need to be convinced that GLP-1 therapy is safe and effective, Intarcia’s biggest hurdle will be convincing them the pump is reliable. That they have done everything humanly possible to limit system failures and malfunctions. The fact that the patient doesn’t need to do anything already eliminates the leading cause of device failure and/or malfunction – human error.

The bottom line for any implantable system, whether it be drug delivery or glucose sensing, is it will ultimately make the life of the patient easier. Simply put these technologies put the patient’s needs where they should be – first. Anyone who’s ever taken an insulin injection, calibrated an insulin pump, used a CGM, checked their glucose levels multiple times per day or swallowed a plethora of pills knows this.

Still no other system that we are aware of makes the patient’s life so simple. The future is coming and Intarcia is just one company that’s leading the way.