Simple is better

Years ago during a sit down with the late Al Mann we got on the subject of what was then one of the new patch pumps. Unlike the OmniPod system which is fully disposable this particular system was a semi-disposable. The system also required quite a few steps to be performed by the patient. While we both understood the business reasons for a semi-disposable Al noted “The more chances you give a patient to screw up the greater the chance they will screw it up.” Like Momma Kliff Al had a knack for stating the obvious.

We mention this as we prep for the upcoming ADA confab which will be in that beautiful city by the bay. One of the bigger stories we anticipate emerging from the conference is Novo Nordisk and their recently submitted oral version of semaglutide. Novo has bet the farm on this drug using a priority review voucher. Novo has already had tremendous success in the growing GLP-1 space first with Victoza and now with Ozempic.

Like Lilly they see the insulin market becoming even more price sensitive knowing its only a matter of time before a biosimilar short-acting insulin comes along and devastates that market as Basaglar has the long-acting market. Simply put Novo needs this drug to be a hit and a big hit.

Now on the surface the stars would seem to be aligning for this drug to be a blockbuster. It will be the first GLP-1 that can be taken orally. Based on all available study data it appears to have all the benefits of the injectable GLP-1’s and we have yet to speak any respected researcher who sees any issues with the drug. Everyone seems to believe the drug will breeze through the FDA and will hit the market sometime early in 2020.

Yet the kink in the armor just might be what happens when the drug moves from the clinic into the real world. A real world filled with patients who don’t read labels and rarely follow instructions. Patients who prefer simple and stupid. Patients who just might be a little confused by the drugs rather complex dosing regimen. A regimen which require it be taken on an empty stomach, with a specific amount of water and then no food intake for another 30 minutes. Violate any one of these three protocols and the drug DOES NOT WORK.

It’s ironic and somewhat sad that many of the researchers who we’ve spoken too about the drug dismiss the drugs rather complex dosing regimen. Being researchers and not patients they just assume patients will follow these instructions to the letter because the drug when dosed properly does work very well. As one noted and highly respected researcher told us recently, “Hey all the patient has to do is take the drug every morning before they shower, and they are good to go.”

This may work in the clinic but in the real world we know differently. Yes if the only requirement was the drug be taken on an empty stomach no problem. If the only requirement was no food intake for 30 minutes after taking it again no problem. If the only requirement was it be taken with a specific amount of liquid even that could be overcome. But when all THREE requirements are necessary, we see nothing but problems when this drug reaches the market and gets in the hands of patients.

The problems will start when Novo starts explaining this to physicians and not just the researchers who did some of the clinical work. Physicians who are used to prescribing oral meds whose only requirement is the patient actually take them. We can’t think of any diabetes medication which requires that it be taken with a specific amount of liquid. Nor are aware of any that must be taken on an empty stomach or when once taken no food intake for 30 minutes. We for sure aren’t aware of any drug which requires all three elements.

Next will come what happens when this drug gets into the hands of patients. Most of whom who do not read labels or remember the instructions given by their doctor or pharmacist. Most of whom who just want to get up everyday take their pills and be on their way. They do not want to have to worry about or remember that this drug must be taken with a specific amount of water or that they cannot eat anything for another 30 minutes after taking it. They want to get going get their Starbucks and maybe a donut.

Let’s be very clear here we have no issues whatsoever with the safety or efficacy of the drug. And let’s be even clearer we are impressed by the results, there is no question the drug works very well when dosed properly. Take away the dosing regimen and we too would be shouting from the rooftops that Novo has a mega-blockbuster on their hands. Yet we cannot take that away which is why we are cautious in our approach.

Can Novo overcome these obstacles; we think so but again this just puts added pressure on the company to execute. Listen it’s never easy to bring any new drug market even when that drug has a simple dosing regimen. Our concern here is that Novo doesn’t have a great history with oral meds, not their core competency, combined with the many changes in Novo management team. Changes that come just when they are launching the most important drug at the most critical time.

Should this drug not meet expectations, expectations which keep rising by the day, Novo stakeholders could be in for a very rude awakening. Insulin, the company’s bread and butter franchise continues to become a commodity. Competition in the injectable GLP-1 market is fierce and new GLP-1 products, i.e. the Intarcia exenatide micro-pump are coming. Novo must execute with near perfection and then hope that physicians and patients comprehend their message and ultimately follow the dosing instructions.

Again we are not saying this cannot be done all we are saying is that this drug which everyone seems to believe is a slam dunk to become a blockbuster has issues that are being overlooked. Listen no expected a 65-1 long shot to win the Kentucky Derby nor did they expect this victory to come because the winner of the race was disqualified. But as Momma Kliff says this stuff as crazy as it seems does happen. Right now Novo owns the favorite to win the oral GLP-1 race but as the Derby shows the favorite even when it crosses the finish line first does not always win the race.