Novo Nordisk A/S has a successor ready within the wings for the technology of weight-loss pictures it pioneered: a capsule that helps folks shed kilos with out the drawbacks of an injection.
The medication is the following frontier within the weight problems battle, promising additional billions in income, and Novo is main as soon as once more. Hassle is, it may possibly’t launch the drug extensively with out endangering its present best-sellers.
The capsule helps sufferers lose roughly as a lot weight because the blockbuster Wegovy. However the oral model requires much more of the identical energetic ingredient, known as semaglutide, and Novo already can’t make sufficient of it to satisfy demand.
That leaves Novo in a bind. Both it finds a approach to additional ramp up manufacturing or it curtails the capsule’s launch, ceding floor to rivals speeding to develop competing merchandise, like Eli Lilly & Co., Amgen Inc. and Pfizer Inc.
Chief Govt Officer Lars Fruergaard Jorgensen acknowledges that Novo underestimated the demand when it initially drew up plans for a capsule.
Now the corporate, which initially deliberate to use for U.S. regulatory approval final yr, has to contemplate how finest to handle its restricted semaglutide provide.
“It’s clear that once we make a pill model and use semaglutide, we have to use quite a bit,” Jorgensen mentioned in an interview on Wednesday in New York. “We can’t conquer the world with that expertise as a template.”
Novo has postponed a U.S. regulatory submitting to this yr and now says it’s going to await the outcomes of extra scientific exams, together with one investigating a lower-dose model that might require much less of the energetic ingredient.
At stake is keep on prime of the wave of weight problems gross sales that has boosted Novo’s market worth past $530 billion, making it Europe’s prime firm and a development engine for the Danish financial system. Shares of Novo rose practically 2.5% Friday, and are up 72% up to now 12 months.
Novo on Monday struck a deal to pay $11 billion for 3 factories as a part of its shareholder Novo Holdings A/S’s acquisition of Catalent Inc. Jorgensen, in a Bloomberg Tv interview, touted the transaction as a “big alternative to serve extra sufferers” searching for remedy with Wegovy and its sister drug, the diabetes shot Ozempic.
Competitors is heating up between Novo and Lilly, whose not too long ago authorized Zepbound is predicted to turn into the best-selling drug in historical past. An experimental weight-loss capsule it’s creating moved final yr into the final stage of scientific exams.
A pill is the following milestone for a market that Bloomberg Intelligence analysts estimate will attain $80 billion by 2030. However it’s not the one consideration for drugmakers, who’re additionally engaged on making next-generation therapies that set off fewer unintended effects, require much less frequent administration or decrease the muscle loss that may happen with fast weight change.
Lilly’s experimental capsule is a unique sort of molecule from Novo’s that, no less than in concept, ought to be simpler to make and probably cheaper, mentioned Michael Shah, an analyst for Bloomberg Intelligence. It will also be taken with meals, he mentioned. In a survey, a couple of third of medical doctors informed Shah and colleagues that they prescribe oral medicine earlier than pictures. Whereas injecting Wegovy with a pen isn’t as sophisticated as some may assume, “a capsule would basically open up the market,” Shah mentioned.
Volunteers taking the Novo capsule alongside eating regimen and train counseling misplaced about 17% of their physique weight over 68 weeks in take a look at outcomes launched final yr. The medication contained 50 milligrams of semaglutide, about 20 occasions as a lot as within the strongest dose of the weekly Wegovy injection.
Novo already sells a capsule for diabetes below the title Rybelsus that makes use of much less semaglutide than its experimental one — although nonetheless greater than the pictures — and whose annual income is a couple of fifth of Ozempic’s.
The Danish firm has different capsules in improvement. They embody a drug acquired final yr within the buy of Inversago Pharma, which Jorgensen mentioned might in all probability be made in a lot bigger portions. One other early-stage one works in an identical approach to CagriSema, Novo’s experimental next-generation shot.
Totally different wants
Whereas the drugmaker is continuing on all these fronts, Jorgensen mentioned that Novo might not have to promote an weight problems capsule extensively to remain aggressive.
Japan is an instance of a market the place a pill is essential, he mentioned, as a result of solely specialists prescribe injected remedy. Novo has separate research to check its capsule in Asian sufferers. And within the US, he allowed, a every day capsule will likely be a most popular choice for some. However changing the whole market, with lots of of thousands and thousands of potential sufferers, won’t be doable, the CEO mentioned. The drugmaker’s market surveys recommend it isn’t needed.
“The bulk would say, ‘Nicely, I would favor a pill,’” Jorgensen mentioned. “However for those who give them the choice of a weekly injection with the efficacy that semaglutide is bringing, that could be very enticing.”