From neutral to overdrive?

Never let it be said that diabetes isn’t one wacky world. For weeks now, we’ve been noting that Novo Nordisk is being Novo Nordisk taking their sweet time getting the oral version of semaglutide to the FDA. Never known for being swift or aggressive the company may be in the verge of an about face. Per a report on the FirecePharma website;

“The Danish drugmaker is considering using a priority review voucher for the candidate, a company spokesman confirmed by email. Doing so would expedite semaglutide’s trip down the regulatory pathway—and hasten a head-to-head battle in the diabetes sphere with drugs including Eli Lilly’s Trulicity.”

Should Novo us the priority review voucher the drug could be approved by the end of next year and set the table for a battle with Lilly for supremacy in the growing GLP-1 space. Many analysts are already giving the edge to Novo based on the one fact that they would have the only oral GLP-1 on the market. While we don’t doubt that being taken orally is a major advantage it’s not the advantage everyone thinks it is given the complex dosing regimen.

As we have noted the drug must be taken on an empty stomach and only with a certain amount of water violate either protocol and the drug doesn’t work. While these obstacles can be overcome, they do add an element of uncertainty to what most believe is a sure thing.

Yet the dosing regimen isn’t the only issue we see as everyone seems to have written off the exenatide micropump from Intracia. The company was hit with a complete response letter which everyone just assumed would kill the micropump. We see this as a serious miscalculation and the possibility exists that the micropump could be coming to market at the same time as the oral version of semaglutide.

The complete response letter had nothing to do with whether the system worked and had more to do with manufacturing processes, processes which have been fixed. Sources indicate the company is working closely with the FDA and could well have their resubmission ready in the near future.

This would set up an interesting three-way battle between Trulicity from Lilly, the oral version of semaglutide from Novo and the Intracia micropump. Of the three it could be argued that Trulicity has the cleanest delivery system it’s not quite point and shot but close. The drawback and this shows how far we have come in this space is it must be injected each week. This would seem to open the door for the oral version of semaglutide until one considers the dosing protocol.

This then opens the door for the micropump as once inserted the patient does nothing. It’s this insertion process that seems to bother analysts but no one else. The process is not just simple and painless physicians can be paid for the procedure which is a major plus. As we have written in the past once inserted the micropump solves the biggest issue facing patients, therapy adherence.

No matter what happens in this space one thing is very clear GLP-1’s are here to stay and that is not good news for the insulin market. Lilly and Novo see this but our friends in Paris have yet to read the memo as they have nothing substantive in the GLP-1 space.

So, for the moment the GLP-1 market is a three-horse race with two thoroughbreds and one up and comer who had some trouble getting out of the starting gate. We wouldn’t count out the up and comer for as we’ve seen before a bad start does not necessarily mean the horse cannot have a strong finish. About the only thing we can count on is that nag in fourth place who hasn’t a clue on how to run any race in diabetes.