Can Novo’s blockbuster push on obesity drug semaglutide succeed where others failed?

Analysts have some high expectations for Novo Nordisk’s weight drug semaglutide, but they’re no higher than the ones held by Novo’s executive team.

Pegged as a potential $2.2 billion drug in 5 years in one recent assessment, Novo execs during Wednesday’s Q2 call reviewed the Phase II obesity data they had nailed down in June, outlining plans for a looming Phase III that they believe can show their GLP-1 drug can knock off up to around 15% of an obese person’s weight relative to placebo.

Lars Fruergaard Jorgensen

In the mid-stage study, researchers tracked an average 17.8 kilogram (39 pound) weight loss from an average baseline weight of 111 kilos, or 244 pounds, for all the patients in the drug arm who completed the one-year trial. That’s a 16.2% weight loss in the drug group, compared to 2.3% in the placebo arm.

Their other weight drug Saxenda is generally relied on to knock off 5% to 10% of a person’s weight, marking this new drug’s potential to set a “new efficacy standard for anti-obesity medicines,” in the words of R&D chief Mads Krogsgaard Thomsen in the call.

Five years ago a group of new weight drugs were winding their way through the FDA approval process. They made it, after clearing some high hurdles for drugs aiming at a big market, but the commercial reception for the marginal weight loss they could be expected to deliver was awful. Arena bailed on Eisai, leaving it with Belviq, Takeda dropped out of their Orexigen pact and rival Vivus was left selling Qsymia with a handful of reps, with revenue falling.

Novo thinks much better efficacy can assure real success, and the pharma company is planning to mount a new and even more ambitious rollout, if the Phase II data hold up.

Significantly, Novo is also relying on a good safety profile so far in obesity, without any evidence of retinal disease, which has popped up in their diabetes study.

CEO Lars Fruergaard Jorgensen also confirmed that they are taking the higher, once-weekly doses into Phase III, which will launch next year. In his words:

Yes, so we basically plan to conduct a three, as you correctly stated, using a once weekly application and as we have done also in type two diabetes in more than 8,000 individuals. The basis for calculating the dose is obviously the usual benefit/risk assessment and since there were no unexpected risks or adverse events or side effects associated with semaglutide other than those related to GLP-1 agonists therapy, it’s obvious that we will go towards the higher end of the dose range.

And I can inform you that going into more detail that at both the highest doses, 1.3 and 1.4, we are speaking to the tune of 15 to 17 plus kilogram weight loss after a 1-year treatment in those patients who complete. So that is what we are expecting. And Saxenda in that very trial performed like it should do, given the kind of efficacy level that we have seen in the SCALE studies. So this is a new level of efficacy which is why we are already now planning for the Phase III program.

This time around Novo says it can be different. And it could use a new blockbuster now as the diabetes market undergoes some marked changes.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
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Atlas Venture Cambridge, MA

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