Roche has already budgeted for future commercial manufacturing builds and established a network of contract manufacturers as it preps for the launch of its GLP-1/GIP drugs.
The company discussed its manufacturing plans during an investor call on Friday at the European Association for the Study of Diabetes Annual Meeting.
Manu Chakravarthy“The organization is gearing up with all of the necessary requirements to supply the medicines [GLP-1/GIPs] that we need not only for clinical [trials], but hopefully for the launch as well,” said Manu Chakravarthy, Roche’s SVP and global head of cardiovascular, renal and metabolism product development.
Capacity constraints have been a major issue for pharma companies like Eli Lilly and Novo Nordisk that market GLP-1 drugs. Now, Roche is outlining its production strategy for assets still being tested in mid-stage trials.
Roche has a network of contract manufacturers that produce clinical supply of its injectable peptide assets, according to Chakravarthy. Currently, there are no “near-term capacity constraints” for these products, according to the company presentation.
As for commercial supply, Roche said it has the runway to build future capacity if necessary and expects its contracted third parties to be able to add capacity by the time its injectable peptide assets are approved and ready to be launched.
Novo and Lilly have both dealt with supply constraints of their blockbuster GLP-1 drugs, and have boosted capacity for both drug production and for the injectable pens. Novo has said it’s open to partnering with third-party manufacturers for filling and packaging injectable pens and is also in the process of buying three of Catalent’s fill-finish sites from Novo Holdings, after it acquires Catalent.
In terms of developing the injectable devices, Roche said it can manufacture the injection pen in-house, but it’s also looking to secure “strategic partnerships” for device development.
Roche has two Phase 2 injectable peptide products. It has a GLP-1/GIP asset called CT-868 that it’s testing for type 1 diabetes and obesity, with data expected in 2025. Meanwhile, its other injectable peptide, CT-388, is being investigated in a mid-stage trial as a GLP-1/GIP treatment for obesity and type 2 diabetes.
A third asset, an oral GLP-1 product called CT-996, is in Phase 1. It has a more “straightforward” production process because it is a small molecule, rather than a peptide, Chakravarthy said. Roche plans on using its pre-existing manufacturing network to make CT-996, he added.
CT-996 is being investigated as a treatment for type 2 diabetes and obesity, and the Phase 1 data already give Roche “the confidence” to launch into Phase 2 trials, Chakravarthy said.
Meanwhile, Novo and Lilly are both focused on boosting their GLP-1 manufacturing footprint as fast as they can, with Lilly recently opening an $800 million extension of a site in Ireland while Novo has earmarked $4.1 billion for a new site in the US.