Lilly to boost manufacturing capacity to support weight-loss pill candidate

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Lilly to boost manufacturing capacity to support weight-loss pill candidate

Published: Feb 07, 2024

By Tristan Manalac

BioSpace

Eli Lilly is ramping up its current manufacturing capabilities while also making early investments to prepare for its next-generation, oral weight-loss candidate, company officials announced Tuesday during its fourth-quarter 2023 earnings call.

“Our top priority is creating new capacities,” Lilly CEO David Ricks said during the question-and-answer portion of Tuesday’s investor call. Ricks was responding to a question about how the company is managing its current clinical and commercial investments for its oral obesity candidate orforglipron, particularly as it advances into late-stage development.

In June 2023, Lilly posted Phase II data for orforglipron, demonstrating that the investigational weight-loss pill could cut body weight by 8.6% to 12.6% after 26 weeks of follow-up. Placebo counterparts, on the other hand, lost only 2% of their body weight during this timeframe.

Orforglipron’s weight-loss effects were durable until 36 weeks, at which point treated patients dropped 9.4% and 14.7% of their body weight, compared to only 2.3% in the placebo arm.

“We do plan to build ahead of Phase III at risk,” Ricks said during the call, adding that Lilly is optimistic regarding the probability of positive late-stage data. “We see that as a wise investment … and if we’re wrong, okay, we’ll have to eat that in the end.”

Like the dominant weight-loss therapies currently in the market, orforglipron is a GLP-1 receptor agonist, which works by mimicking the GLP-1 hormone to promote the secretion of insulin into the bloodstream in response to blood glucose levels. Unlike other obesity drugs, however, orforglipron is designed to survive the gastrointestinal tract and can be taken orally.

This oral administration positions Lilly’s weight-loss pill as a key differentiator to other GLP-1 agonists which are injectable medications.

“When we look at the opportunity in obesity, we have more than 110 million in the U.S. and 650 million globally,” Patrik Jonsson, president of Lilly Diabetes and Obesity, said in a statement “It’s impossible to reach all of those with injectables,” especially given the current supply constraints. “I think that’s the big opportunity we have for orforglipron.”

The obesity market is currently dominated by Novo Nordisk’s semaglutide—marketed as Ozempic for type 2 diabetes and Wegovy for weight management—and Lilly’s tirzepatide, branded as Mounjaro for type 2 diabetes and Zepbound for weight loss. All these products are currently in short supply, opening the door for counterfeit and compounded products to flood the market.

Novo has taken major steps to up its manufacturing capacity, announcing a $6 billion investment in November 2023 and acquiring CDMO giant Catalent for $16.5 billion on Monday.

Source: BioSpace