All in ….

Wednesday Novo Nordisk put all their chips on the table submitting the oral version of semaglutide to the FDA using a priority voucher. If as we expect the FDA approves the drug it will set up one of the most important drug launches in the company’s history. Many analysts believe that as the first oral GLP-1 this is a slam dunk for Novo providing the blockbuster product the company desperately needs. While we believe there will be lots of interest in the drug, we aren’t yet convinced it’s a slam dunk blockbuster.

Given the company is using a priority review voucher they fully appreciate just how important this drug is to their future. They see what we see, an insulin market continuing to commoditize while GLP-1 usage continues to grow. However they are also aware that while this drug offers great potential the devil is in the details. As we have noted in previous posts patients do not simply pop this pill in their mouths and then wash it down with some water.

Unlike other oral medications this drug has a somewhat complex dosing regimen. As we noted previously if the patient takes the drug at the wrong time or with too much water IT DOESN”T WORK. Now this is not an insurmountable obstacle for Novo, but it does complicate the launch as it places additional demands on the company.

There is no question in our mind given the increasing usage of GLP-1’s this drug will command the attention of physicians. Most of whom who have no idea how the drug is dosed. The key question becomes will these physicians prescribe an oral medication that comes with a complex set of instructions.

The use of the priority review voucher also shows Novo is not oblivious to what’s coming as the Intarcia exenatide micropump is by no means dead. Although the company has experienced some setbacks, we anticipate they will work out their issues with the FDA and this system will be on the market. So the choice for physicians becomes do they prescribe an oral GLP-1 with a somewhat complex dosing regimen or recommend a micropump that is inserted in the patient’s body?

Taking away reimbursement, always an important factor, we’d give the edge to Intarcia for the simple reason as once inserted the patient doesn’t do a damn thing. Everyone mistakenly assumes patients take their pills when they are supposed to, but we all know this is not the case. The biggest obstacle standing between better outcomes and patients is therapy adherence, the micropump takes away this issue. This has always been the most compelling reason why we like the micropump it makes diabetes management stupid.

Our guess and it’s a damn good guess is that Novo is working aggressively with payors to get this drug on formulary. For besides the coming of the Intarcia micropump they know Lilly will do whatever they can to protect their growing Trulicity franchise. Don’t be surprised if Lilly becomes more aggressive not just with payors, that’s a given, but in their marketing playing up the fact patients only have to take Trulicity once a week rather than once a day. Nor should it surprise anyone when the Lilly team starts casually mentioning how Novo’s drug is dosed.

The use of the priority voucher Novo’s desperate need for a blockbuster combined with the competitive dynamic will make this interesting to watch. Novo has gone all in the question now becomes is their hand strong enough should Lilly or Intarcia call. Doyle Brunson perhaps the greatest poker player of all time once said; “The key to No-Limit… is to put a man to a decision for all his chips.” Novo has done just that let’s hope for their sake they have the cards to back up this bet.