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The companies have extended a contract agreement for the commercial manufacture of the active pharmaceutical ingredient for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.
On May 8, 2018, Lonza Pharma & Biotech and Proteon Therapeutics, a company that develops therapeutics for kidney and vascular diseases, announced the extension of a long-term contract for the commercial manufacture of the active pharmaceutical ingredient (API) for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.
Lonza has manufactured APIs 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 optimization and consistency studies. The process was then scaled up to 1000-L scale cGMP manufacture to support Proteon’s early clinical studies and potential commercial requirements, as stated by Lonza.
Vonapanitase is currently being studied in a Phase III clinical trial in patients with chronic kidney disease and has received breakthrough therapy, fast track, and orphan drug designations from FDA, as well as orphan medicinal product designation from the European Commission for hemodialysis vascular access indications. Proteon is also conducting a Phase I clinical trial of the drug in patients with peripheral artery disease.
“Proteon and Lonza have had a strong relationship for nearly a decade, and this amendment extends that relationship,” said Timothy Noyes, president and CEO of Proteon, in a company press release. “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.”
As Proteon worked to complete enrollment in its ongoing Phase III clinical trial, Lonza supported Proteon with three process validation batches at 1000-L commercial scale. If the clinical trial is successful, Proteon expects to include results from these validation runs in a potential biologics license application filing in the second half of 2019.