Dive Brief:
- Kidney disease specialist Proteon Therapeutics has extended its agreement with Lonza Pharma and Biotech to manufacture the raw ingredients for Proteon's experimental drug vonapanitase, pushing an existing deal out through 2029.
- Lonza, one of the world's largest contract manufacturers for the biopharma industry, has upscaled its production processes at its facility in Visp, Switzerland, to meet Proteon's needs as vonapanitase moves through late-stage testing.
- Proteon expects to file a Biologics Licensing Application for vonapanitase sometime in the second half of 2019. The drug is currently in Phase 3 study to test whether it can improve vascular access for hemodialysis.
Dive Insight:
Proteon Therapeutics and Lonza have been working together since 2009, when vonapanitase was in Phase 1/2 development in patients with end-stage renal disease undergoing surgery for arteriovenous fistula (AVF) creation. The drug aims to improve hemodialysis vascular access outcomes through a single dose given during surgery.
Since 2009, Lonza has shifted vonapanitase production from a small-scale process through lab-based process optimization to its current 1,000 L current Good Manufacturing Practice (cGMP) commercial scale for clinical trials and potential commercialization.
"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," said Timothy Noyes, president and CEO of Proteon.
Proteon recently completed enrollment for its ongoing vonapanitase Phase 3 trial PATENCY-2. The company had to modify the PATENCY-2 study a year ago, expanding its enrollment to 500 following the 2016 failure of the PATENCY-1 Phase 3 study to meet its primary endpoint.
PATENCY-2 is expected to read out in March 2019. For this study, Lonza supplied three process validation batches at 1,000 L commercial scale.