Argenx says it is ready to launch antibody fragment efgartigimod late this year despite alleged supply chain concerns stemming from its CDMO Lonza.

Argenx’s lead candidate efgartigimod is a first-in-class investigational antibody fragment targeting the neonatal Fc receptor (FcRn). The candidate is being evaluated for the treatment of patients with severe autoimmune diseases and has been accepted for review by the US Food and Drug Administration (FDA) for Generalized Myasthenia Gravis (gMG).

With a Prescription Drug User Fee Act (PDUFA) target action date of December 17, 2021, the firm is prepping for launch but was asked during its first quarter financial call whether manufacturing will be ready, following speculation of delays at contract development and manufacturing organization (CDMO) Lonza.

Image: iStock/Jim_Pintar

“We already have commercial supply that is manufactured and ready to go for launch,” said chief operating officer Keith Woods to shareholders.

He added: “We have a very good relationship with Lonza and I can tell you that we speak to them pretty much on a weekly basis going through all of the logistics. I feel quite confident in where we are now, and we’ve taken all the precautions that we can. So, unless something unforeseen [happens], we should be in good shape.”

Argenx entered a multi-product commercial licence agreement in February 2015 with Lonza for the production of therapeutic antibodies. 

Lonza supply

Lonza is also the key manufacturing partner for Moderna in the rollout of its COVID-19 mRNA vaccine, with its site in Visp, Switzerland contracted to make hundreds of millions of doses.

However, there have been concerns that the CDMO was struggling to meet supply targets for Moderna.

Reuters reported in April that Moderna anticipated vaccine shipments to Canada and Britain to be delayed after issues with its vaccine manufacturing supply chain, which includes Lonza.  

It was even alleged the CDMO had tapped fellow Swiss company Nestle for workers in order to service its deal to produce drug substance for hundreds of millions of doses of Moderna’s COVID-19 vaccine. 

However, Lonza has denied any supply issues and refused at the time to confirm the redeployment of staff or comment on the story when approached by us.

The CDMO recently began installing three new production lines at Visp to support the Moderna contract, and this month the firm invested $715 million to expand its mammalian cell culture capacity at the site.