Proteon extends vonapanitase manufacturing deal with Lonza

15-Jul-2015 - Last updated on 16-Jul-2015 at 14:08 GMT

Proteon is investigating a drug to stop potential blockages during arteriovenous fistula dialysis

Proteon Therapeutics has extended a deal with Lonza for the development and manufacture of its lead product, the pancreatic elastase candidate vonapanitase.

Vonapanitase is Proteon’s Phase III candidate for improving arteriovenous fistula (AVF) patency in patients with chronic kidney conditions following surgical procedures, such as hemodialysis.

The Massachusetts-based biopharma firm originally entered into a contract with Lonza in September 2009 for the clinical production of vaonapanitase, but according to a note filed with the SEC, Proteon signed a seven year service agreement last week for the CDMO to process, develop and manufacture the active pharmaceutical ingredient (API) in vonapanitase.

“Lonza will first manufacture Process Validation Batches and Engineering Batches,” the filing says. “Lonza will then manufacture batches in accordance with current Good Manufacturing Practices (cGMP) and deliver them to Proteon along with certain documentation that is necessary for regulatory compliance.”

Under the terms, Lonza is responsible for procuring all required raw materials to prepare the batches while Proteon will be responsible for the cost. Proteon will also maintain one representative at Lonza’s facility during the production process.

“Lonza has been providing development and manufacturing services to Proteon for many years,” Proteon CEO Timothy Noyes told this publication. “Outsourcing allows us to benefit from the most advanced development and manufacturing services available.”

Lonza was selected “because of its expertise in biologics,” he added, and as the firms have already been working together, no tech transfer is necessary.

AVF is a form of vascular access for hemodialysis patients but, according to Proteon, it often fails due to blockages formed through the growth of tissues inside arteries of veins during the process. Vonapanitase is a recombinant human elastase being investigated to increase the AVF patency in such patients.

“Elastase fragments elastin, a protein in the wall of blood vessels that plays an important role in blood vessel remodelling in response to injury,” Noyes said. “Research shows that fragmenting elastin in the outer layer of the blood vessel wall can promote positive remodelling, including blood vessel dilation and avoidance of excessive cell migration to the inside of the blood vessel that can cause a blockage.”