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Novo Nordisk A/S has a successor waiting in the wings for the generation of weight-loss shots it pioneered: a pill that helps people shed pounds without the drawbacks of an injection.
The medicine is the next frontier in the obesity fight, promising further billions in revenue, and Novo is leading once again. Trouble is, it can’t launch the drug widely without endangering its existing best-sellers.
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The pill helps patients lose roughly as much weight as the blockbuster Wegovy. But the oral version requires far more of the same active ingredient, called semaglutide, and Novo already can’t make enough of it to meet demand.
That leaves Novo in a bind. Either it finds a way to further ramp up production or it curtails the pill’s launch, ceding ground to rivals rushing to develop competing products, like Eli Lilly & Co., Amgen Inc. and Pfizer Inc.
Chief Executive Officer Lars Fruergaard Jorgensen acknowledges that Novo underestimated the demand when it originally drew up plans for a pill.
Now the company, which originally planned to apply for U.S. regulatory approval last year, has to consider how best to manage its limited semaglutide supply.
“It’s clear that when we make a tablet version and use semaglutide, we need to use a lot,” Jorgensen said in an interview on Wednesday in New York. “We cannot conquer the world with that technology as a template.”
Read More: Weight-Loss Drugs Come With Serious Side Effects, According to a New Study
Novo has postponed a U.S. regulatory filing to this year and now says it will await the results of more clinical tests, including one investigating a lower-dose version that would require less of the active ingredient.
At stake is how to stay on top of the wave of obesity sales that has boosted Novo’s market value beyond $530 billion, making it Europe’s top company and a growth engine for the Danish economy. Shares of Novo rose nearly 2.5% Friday, and are up 72% in the past 12 months.
Novo on Monday struck a deal to pay $11 billion for three factories as part of its shareholder Novo Holdings A/S’s acquisition of Catalent Inc. Jorgensen, in a Bloomberg Television interview, touted the transaction as a “huge opportunity to serve more patients” seeking treatment with Wegovy and its sister drug, the diabetes shot Ozempic.
Competition is heating up between Novo and Lilly, whose recently approved Zepbound is predicted to become the best-selling drug in history. An experimental weight-loss pill it’s developing moved last year into the last stage of clinical tests.
A tablet is the next milestone for a market that Bloomberg Intelligence analysts estimate will reach $80 billion by 2030. But it’s not the only consideration for drugmakers, who are also working on making next-generation treatments that trigger fewer side effects, require less frequent administration or minimize the muscle loss that can occur with rapid weight change.
Lilly’s experimental pill is a different type of molecule from Novo’s that, at least in theory, should be easier to make and potentially cheaper, said Michael Shah, an analyst for Bloomberg Intelligence. It can also be taken with food, he said. In a survey, about a third of doctors told Shah and colleagues that they prescribe oral drugs before shots. While injecting Wegovy with a pen isn’t as complicated as some might think, “a pill would essentially open up the market,” Shah said.
Strongest dose
Volunteers taking the Novo pill alongside diet and exercise counseling lost about 17% of their body weight over 68 weeks in test results released last year. The medicine contained 50 milligrams of semaglutide, about 20 times as much as in the strongest dose of the weekly Wegovy injection.
Novo already sells a pill for diabetes under the name Rybelsus that uses less semaglutide than its experimental one — though still more than the shots — and whose annual revenue is about a fifth of Ozempic’s.
The Danish company has other pills in development. They include a drug acquired last year in the purchase of Inversago Pharma, which Jorgensen said could probably be made in much larger quantities. Another early-stage one works in a similar way to CagriSema, Novo’s experimental next-generation shot.
Different needs
While the drugmaker is proceeding on all these fronts, Jorgensen said that Novo may not need to sell an obesity pill widely to stay competitive.
Japan is an example of a market where a tablet is key, he said, because only specialists prescribe injected therapy. Novo has separate studies to test its pill in Asian patients. And in the US, he allowed, a daily pill will be a preferred option for some. But converting the entire market, with hundreds of millions of potential patients, will not be possible, the CEO said. The drugmaker’s market surveys suggest it isn’t necessary.
“The majority would say, ‘Well, I would prefer a tablet,’” Jorgensen said. “But if you give them the option of a weekly injection with the efficacy that semaglutide is bringing, that is very attractive.”
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The company can’t launch the new drug without endangering its best-sellers.
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Health – TIME
