Lilly to pour $6.5 billion into GLP-1 pill manufacturing site

Eli Lilly and Company plans to ramp up production of the active ingredient for a once-daily weight-loss pill, even though the drug candidate has yet to receive approval from the US Food and Drug Administration.

The company says it will invest $6.5 billion in a manufacturing facility at the Generation Park complex in Houston. Lilly expects to apply for FDA approval of the new drug, orforglipron, by the end of the year. The new facility is expected to open within 5 years.

While Lilly plans to produce various drug ingredients at the site, its focus will be on orforglipron, a small molecule that it is developing as a treatment for type 2 diabetes and weight loss. The drug candidate acts as an agonist of the glucagon-like peptide-1 (GLP-1) receptor, following the same mode of action as Mounjaro (tirzepatide), the company’s peptide-based GLP-1 drug for weight loss. 

“Our new Houston site will enhance Lilly’s ability to manufacture orforglipron at scale and, if approved, help fulfill the medicine’s potential as a metabolic health treatment for tens of millions of people worldwide who prefer the ease of a pill that can be taken without food and water restrictions,” Lilly CEO David A. Ricks says in a statement. 

The company says it will use tools such as machine learning, artificial intelligence, and digitally integrated systems to run the new facility.

This year, Lilly has been releasing the results of clinical studies finding that orforglipron is safe and efficacious in patients with obesity or type 2 diabetes. Recently, the company published data from a new study that found orforglipron outperformed an oral version of semaglutide, the active ingredient in Novo Nordisk’s weight-loss peptide.

The GLP-1 drugs on the market today are mostly peptide-based injectables. But Lilly, Novo Nordisk, and other companies are developing small-molecule-based pills that are easier and cheaper to manufacture than peptides.

Lilly’s announcement is the latest in a string of proclamations by drug companies of plans for more US manufacturing capacity. Earlier this month, Lilly and GSK both announced plans for new US facilities. Last year, Lilly said it would build more manufacturing capacity for tirzepatide.