Lonza, Proteon Therapeutics Extend API Biomfg Pact

Lonza has extended its contract with Proteon Therapeutics, a Waltham, Massachusetts-headquartered company developing therapeutics for kidney and vascular diseases, to commercially supply the active pharmaceutical ingredient (API) of Proteon’s lead investigational drug, vonapanitase, a drug for improving hemodialysis vascular access outcomes.

Lonza has manufactured the API for Proteon at its microbial manufacturing facility in Visp, Switzerland since 2009. Initially, a small-scale process was transferred into Lonza’s development labs for process studies. The process was then scaled up to 1,000-liter scale cGMP manufacture to support Proteon’s early clinical studies and potential commercial requirements.

Vonapanitase is in a Phase III clinical trial for treating patients with chronic kidney disease. It has received breakthrough-therapy, fast-track, and orphan-drug designations from the US Food and Drug Administration, and orphan medicinal-product designation from the European Commission, for hemodialysis vascular access indications. Proteon is also conducting a Phase I clinical trial of vonapanitase in patients with peripheral artery disease.

As Proteon worked to complete enrollment in its ongoing Phase III clinical trial, Lonza supported Proteon with three process validation batches at 1,000-liter commercial scale. If the clinical trial is successful, Proteon expects to include results from the validation runs in a potential biologics license application filing in the second half of 2019.

Source: Lonza and Proteon Therapeutics


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