Pfizer CEO talks up experimental oral GLP-1 diabetes/obesity hopeful as $90B Lilly, Novo battle looms

The questions came thick and fast at this year’s J.P. Morgan Healthcare Conference in San Francisco for Pfizer’s CEO Albert Bourla, Ph.D. Many at first focused on the pharma’s COVID-19 drug and vaccine business, but attention turned, inevitably, to what’s coming next.

Bourla still sees billions of dollars in sales this year from the company's COVID drug Paxlovid and its COVID shots and boosters but longer term is betting on around 20 new product launches this decade, one of the largest and more optimistic drug launch predictions from a pharma chief ever uttered at a JPM meeting.

The pharma is making moves in flu and RSV, with combo shots wedded with COVID potentially on the horizon, but one smaller but no less lucrative project has just kick-started midstage testing and could open a major yet increasingly competitive market.

That market is next-gen GLP-1 drugs for Type 2 diabetes and, more recently, for obesity, blockbuster conditions that are dominated by Novo Nordisk’s semaglutide franchise of injectable GLP-1 Ozempic and oral GLP-1 Rybelsus, both for Type 2 diabetes, and new entrant Wegovy, also an injected GLP-1 but with different dosing for certain overweight and obese patients.

There is also a new drug in the form of Eli Lilly’s Mounjaro, approved by the FDA last year for Type 2 diabetes that works as both a GIP (glucose-dependent insulinotropic polypeptide) and a GLP-1. Lilly is already testing the med in obesity and has seen some encouraging results, good enough, in fact, for it to nab a speedy review through a rolling submission last fall from the FDA in overweight and obese patients.

Data for that rolling submission should be finished off by April, and a new approval for Mounjaro, which Evaluate Vantage sees making $4.9 billion by 2026, could be in the cards within the year. Lilly is also not resting on its injectable laurels and is too working on an oral GLP-1 in the form of orforglipron, currently in phase 3 trials in Type 2 diabetes and obesity.   

Lilly and Novo are the leading diabetes drug makers in terms of sales and drugs on offer, but it is not an area you would naturally associate with Pfizer. But, as it has also done in RSV, Pfizer has been quietly working on a new GLP-1 asset, which moved into phase 2 testing at the end of 2022.

That drug, PF-07081532, or danuglipron, comes out of an R&D collaboration pact with Sosei Heptares and is aiming to be a once-a-day oral option for diabetes.

Initially, GLP-1s had to be injected, as Ozempic must be, but an oral version in Rybelsus (and currently the only oral version on the market) is seen as a game changer, literally moving (or removing) the needle, a much-needed respite for diabetes patients. Evaluate Vantage sees 2028 sales hitting $6 billion for the drug.

Mounjaro, meanwhile, is injected but only once a week, which has the effect of reducing the need for injections if not quite removing it.

A major market

Speaking in response to a question about danuglipron’s potential at JPM Monday, Bourla said that while “it’s early days” for the drug, having only passed into midstage testing, “this is a market that will grow to $90 billion altogether. And we are very confident on that given the current size of the market and the current growth rates.”

And Bourla sees the prime mover of that $90 billion market being oral medications such as danuglipron.

“In all the market research that we are doing, we see that there is a preference in the diabetic population for an oral compared to injectable,” he explained, but said this is particularly true for patients with obesity. An oral drug here “unlocks the market,” he told the audience at San Francisco on Monday.  

“It's significantly more important, the oral in the obese market than it is in the diabetic population,” he said, though he added that its importance still counted in the diabetes space. There remain, however, questions over efficacy, as injected GLP-1s are generally seen as being more efficacious. Pfizer is relying solely on an oral treatment, so it will need the data to back it up. 

But while a few years away from the market, Bourla is already sizing up the competition. “In this market, there have emerged three competitors right now, right? Us, Lilly and another,” he said, not naming Novo Nordisk and Rybelsus, but it logically could only be them.

When weighing up Pfizer’s early data from its asset and looking at its competitors, Bourla said “we believe, based on what we have seen, that we have a way stronger profile. We believe we are a full agonist. We see that there is a dose dependence. So, the more we increase the dose, the better the efficacy in our molecule"—something, he said, that hasn’t been seen "with the other molecules.”

Evaluate doesn't agree with that $90 billion market figure, instead seeing it worth just $50 billion by 2028, according to a recent report