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Basel, (CH) and Waltham, MA (USA), 8 May 2018 – Proteon Therapeutics, Inc. (Nasdaq: PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced a long-term contract extension with Lonza Pharma & Biotech for the commercial supply of 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 commercialization and to see the impact for patients.”
Lonza has manufactured API for Proteon at its microbial manufacturing facility in Visp (CH) 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 1,000L scale cGMP manufacture to support Proteon's early clinical studies and potential commercial requirements.
As Proteon worked to complete enrollment in its ongoing Phase 3 clinical trial, PATENCY-2, Lonza supported Proteon with three process validation batches at 1,000L commercial scale, each of which met the intended release criteria. If PATENCY-2 is successful, Proteon expects to include results from these validation runs in a potential Biologics License Application (BLA) filing in the second half of 2019, which Lonza will support.