Hurry up and wait

Well more good news for Novo Nordisk as the company released data from their PIONEER 5 a phase 3a trail for the oral version of semaglutide which per a company issued press release:

“The trial achieved its primary objective according to the primary statistical approach by demonstrating statistically significant and superior reductions in HbA1c with oral semaglutide compared to placebo at week 26. Furthermore, people treated with oral semaglutide achieved statistically significant and superior reductions in body weight compared to placebo at week 26.”

Now this is not the first nor will it be the last study we have seen on this drug. As in Novo tradition they are studying this drug for every possible condition and/or scenario known to man. As each study is released a few things are becoming obvious, the drug works pretty well and there is no logical reason why the drug has yet to be submitted to the FDA.

We continue to believe the drug has blockbuster potential assuming of course it ever gets here and let’s be honest with the way things are going in the insulin market Novo needs this drug to be here. Insulin may be part of Novo DNA but it’s their GLP-1 franchise which is driving the company now. Victoza has exceeded expectations, established a strong market presence and opened the door for the oral version of semaglutide. The injectable version is also a strong drug but must compete head on with Trulicty from Lilly which is currently leading in the long-acting GLP-1 category.

This is why getting the oral version to market is critical as Novo could own this segment and make it next to impossible for a future competitor to gain traction. This drug could become what Januvia became in the DPP4 category.

But Novo being Novo must do study after study before they go to the FDA. This is so predictable that it isn’t funny anymore. Novo was built on the premise of making premium drugs which in turn received premium reimbursement. This world no longer exists but Novo is having a very difficult time adjusting. There have been some signs they are getting the memo but change happens at glacial speed in our wacky world.

We’re also not convinced yet that the company can successfully launch any drug which is not injected. The last time Novo went down this path it was a major disaster. While they may be calling on the same set of doctors there is a huge difference between prescribing an injectable therapy option and an oral one. Negotiations with payors needless to say are also critical as the company does not want to overplay their hand. Think more Januvia and less Lantus.

This is not completely uncharted waters for Novo but they aren’t overly familiar waters either. But for the moment all everyone can do is wait for the next study to come out. Hopefully at some point the studies will end the drug will be submitted and then the clock starts ticking. Barring something unforeseen we suspect the FDA will approve this drug as from what we have seen so far there are no major obstacles.

Yet all we can do now is hurry up and wait.