Approvals in Hand, Lilly and Novo Obesity Pills Will Battle It Out on Hairline Differences

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After Eli Lilly achieved the milestone approval of the weight loss pill Foundayo, Novo Nordisk launched a full-court press to defend oral Wegovy, which has been enjoying a record-breaking launch since January.

The battle is on between Novo Nordisk and Eli Lilly for control of the oral obesity market. Analysts called the game early for Lilly, declaring the approval of Foundayo a foundational moment for the storied company.

“Orforglipron approval puts bears to bed,” declared BMO Capital Markets in a Wednesday note.

Lilly’s shares finished Wednesday up just under 4% to $ 954.52 while Novo dipped.

“We expect Foundayo to blunt the uptake of oral Wegovy upon its availability,” William Blair wrote in a Wednesday note.

But Novo doesn’t intend to go down without a fight. In a statement, the Danish company pointed to differences between the two medications, namely that the Wegovy pill has shown greater weight loss than any other GLP-1.

The FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.

“Not all GLP-1s are the same. Any reports claiming orforglipron is more effective than Wegovy pill for weight management are inaccurate and misleading,” Novo said in a statement emailed to BioSpace.

Novo launched a full-court press to demonstrate the superiority of oral Wegovy on Thursday morning, announcing the upcoming presentation of data showing that the product exceeded weight loss achieved by Foundayo in an analysis from a study called Orion. This was not a traditional clinical trial but a simulated treatment comparison. There have been no head-to-head trials of the two pills conducted.

In the Phase 3 ATTAIN-1 trial that supported its FDA approval, Foundayo achieved average weight loss of 27.3 lbs at 72 weeks, or about 11.2%. The Wegovy pill, meanwhile, elicited 16.6% mean weight loss in the Phase 3 OASIS 4 trial that supported its FDA nod.

Tit for Tat

The launch of Novo’s pill has, by all accounts, gone exceedingly well—a “record breaking start,” according to BMO. Novo said 600,000 scripts have been filled since the January start date.

But Lilly has a lot of firepower behind it. Foundayo received what BMO dubbed a clean label, which the firm said clears the product for broad use in patients with obesity. Lilly’s offering differs from the Wegovy pill in that it can be taken with or without food. Patients taking Novo’s drug have to take it on an empty stomach and wait 30 minutes, which could be seen as a complicating factor for some patients.

But again, Novo defended its product in its statement to BioSpace. “Wegovy pill does not need to be refrigerated and is taken as part of an established once-a-day morning routine, with a sip of water on an empty stomach—sip and go! Go about your morning—waiting 30 minutes before eating, drinking or taking other oral medications.”

These dosing differences will be key to patient uptake as investors watch the market battle between the two companies, BMO noted.

Lilly has priced Foundayo at $149 per month for self-pay customers, the same as the cost for initial doses of the Wegovy pill. The price for Foundayo goes up to $349 for higher doses, a pricing strategy BMO said will help drive volume. The cost of oral Wegovy, meanwhile, climbs to $299 for higher maintenance doses. All told, William Blair gave Novo the pricing edge.

The manufacturing of these products could prove to be another differentiator. Lilly made a subtle but meaningful change in the product that will ultimately be on pharmacy shelves. While a capsule was used in the Phase 3 trials, Lilly will offer a tablet formulation when the drug begins shipping on April 6, Leerink Partners said. This is notable because a tablet uses less active pharmaceutical ingredients (API) and is more efficient to manufacture, making it even cheaper to produce than previously expected.

This could count for a lot, as the drugs differ in their compounds. Lilly’s is a small molecule —typically used for oral medicines—while the Wegovy pill is a peptide. Small molecules are easier to manufacture while peptides can be expensive in higher doses.

While the 10-fold increase in dose over injectable Wegovy has raised questions about the launch, Novo Nordisk has assured investors it has the manufacturing capacity to roll out oral semaglutide without restrictions on supply.

This difference is a feature not a drawback, according to Novo. “With Wegovy pill, Novo Nordisk did what many thought was impossible: putting a peptide, which mimics a naturally occurring hormone, in a pill—building on decades of research in obesity and the development of semaglutide.”

Whoever comes out on top, the availability of multiple oral options for weight loss is a positive for patients, analysts agreed. Nevertheless, William Blair still sees injectables as maintaining the largest share of the overall U.S. market, about 80%. That’s because these versions are more potent and a better option for U.S. patients, who typically have a high BMI, the firm said.

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