A sad ending

A sad ending

Many years ago so long ago in fact that not sure exactly what year it was during the annual JPM Healthcare Conference we sat down with a company which had an interesting concept, deliver exenatide via an implantable pump. Listen this was so long ago we’re not even sure if exenatide had been approved by the FDA yet. We listened intently as we were and still are big believers in GLP-1 therapy. What made this concept so intriguing was not the drug being delivered but how it was being delivered.

Whether the so-called experts want to acknowledge it or not any physician will tell you the biggest obstacle to achieving better patient outcomes is therapy compliance/adherence or whatever the current PC term is. As one primary care physician back then said “if these patients would just take their damn pills/shots whatever we’d all be better off.”

With this device compliance/adherence would be a non-issue as once implanted it would deliver exenatide on a continuous basis for six months. Given how exenatide works there would be no fears of hypoglycemia, control would be excellent and there is the added benefit of weight loss. Yet what made us do the happy dance was the simple fact that once implanted the patient did NOTHING, no glucose monitoring, no daily shots, no taking pills zilch nada nothing. It was almost the perfect solution to the biggest problem facing diabetes management, therapy compliance/adherence.

Back then there were still many obstacles to overcome, developing an insertion device that was patient friendly was just one. Still we were impressed but left this meeting with some free advice for these upstarts. Advice we received from another diabetes device executive who has since moved on from diabetes. He stated the three most important aspects for running a diabetes device where the following;

1. Can you make it?

2. Can you support it?

3. And most importantly can you get paid for?

Now for most companies aspect number 3 was the most difficult step. Making it while never easy almost seemed an afterthought as there are many very smart people out there who specialize in manufacturing processes. Support also seemed a low bar as this could be outsourced if need be and again there are plenty of options. However getting it paid for navigating the payor maze was and continues to be one big hassle.

Yet with this company as they developed over the years seemed to be in tune with each step. They brought in some solid management talent, raised a boatload of money and appeared to be headed for stardom. Each year at JPM their sessions had a bigger audience as investors began eagerly anticipating an IPO. This excitement reached a fevers pitch when at long last the company submitted their device to the FDA.

While we didn’t believe approval would be a slam dunk we were very optimistic. The data looked great, they had come up with a slick insertion device and they understood how to get it paid for. The company itself was confident and began building a sales team. All the stars seemed to be aligned which in diabetes is typically when the bottom falls out., which unfortunately is exactly what happened.

Rather than approval the company received the dreaded complete response letter from the FDA. Now this is not a death sentence and others have overcome it but as Momma Kliff would say it wasn’t a goodness. The issue really had nothing to do with the drug being delivered rather the device that was delivering it. More specifically how the device was being manufactured. Frankly this issue made us feel better as we thought ok get some smart on it fix the issue and go back to the FDA.

Well things didn’t exactly go that way. We don’t need to get into all the gory details here in simple terms is what the problem is. Given how exenatide works and the known issues with the drug it’s critical that device deliver a consistent dose. To put it in even simpler terms think of an insulin pump delivering a bolus when the patient says they want 5 units they want 5 units delivered by the pump, not 3 or 7. Well if this device didn’t operate as designed given the known issues with exenatide it lead to adverse events not seen with conventional injected GLP-1’s.

This created somewhat of a viscous circle since the device didn’t operate properly or should we say since there were issues with the consistency of manufactured lots of devices this in turn lead to adverse events. In essence the issues with manufacturing lead the FDA to determine the device was the problem NOT exenatide but the device which delivered the exenatide.

The company did go back to the FDA who again said no, this in turn lead to the company to appeal the decision which is like a football team being down by a touchdown with no time on the clock throwing a Hail Mary into the endzone. Yes there are rare and memorable Hail Mary’s, but they are called Hail Mary’s because 9 times out of 10 they fail. Which unfortunately is exactly happened here as the FDA as denied the appeal and rather than staying in jail this once promising company is headed for corporate boot hill.

Now some seem to believe that even with one foot in the grave this concept can be resurrected, be brought back from the verge of death and have a Tandem like rise from the ashes of near death. Only problem now is the GLP-1 market has changed and there not one, not two but three once-weekly GLP-1’s. Now no injections are better than once a week injections but given the success of Trulicity and Ozempic once a week hasn’t proven to be a problem.

Add in the fact we now have Rybelsus the first oral GLP-1 what would compel a physician to choose an exenatide pump which is inserted in the body. Listen even with a painless and easy insertion, even with all the benefits this device has to offer human nature being what it is physicians and patients would rather take a pill, even one with the somewhat complex dosing that Rybelsus has.

This sad story belongs to Intarcia. The fat lady is singing a sad tune.