Proteon and Lonza expand long-term contract for supply of API

A long-term contract extension has been agreed by Proteon Therapeutics and Lonza Pharma & Biotech for the commercial supply of the investigational vonapanitase’s active pharmaceutical ingredient (API).

“Proteon and Lonza have had a strong relationship for nearly a decade, and this amendment extends that relationship,” said Timothy Noyes, president and chief executive officer of Proteon. “The amendment provides Proteon with access to a top-tier manufacturing site for the long-term commercial supply of investigational vonapanitase after potential FDA approval.”

“Lonza’s microbial expertise and versatile assets will enable us to anticipate and deliver API for Proteon at this critical phase in the lifecycle of their therapy,” said Marc Funk, COO Lonza Pharma & Biotech.

Karen Fallen, VP, head of Clinical Development and Manufacturing for Lonza, added: “It’s always motivating for our teams to support biotechs like Proteon from Phase I studies through to commercialisation and to see the impact for patients.”

Vonapanitase is an investigational drug intended to improve haemodialysis vascular access outcomes. It is currently being studied in a Phase III clinical trial in patients with chronic kidney disease (CKD).

As manufacturer of APIs for Proteon since 2009, Lonzasupported Proteonwith three process validation batches for the Phase III trial release criteria. If the trial is successful, it is expected that the results will be used to support a potential biologics licence application (BLA) filing, in the second half of 2019.