Lonza and Alnara Pharmaceuticals sign liprotamase agreement
Lonza Group of Switzerland is to manufacture Alnara Pharmaceutical\'s liprotamase. an oral, pancreatic enzyme replacement therapy (PERT) for patients with pancreatic insufficiency. The agreement will support Alnara\'s New Drug Application (NDA) filing for liprotamase and the manufacture of launch quantities of the product.
Lonza Group of Switzerland is to manufacture Alnara Pharmaceutical's liprotamase. an oral, pancreatic enzyme replacement therapy (PERT) for patients with pancreatic insufficiency. The agreement will support Alnara's New Drug Application (NDA) filing for liprotamase and the manufacture of launch quantities of the product.
Under the terms of the agreement, Lonza will provide microbial fermentation, process optimisation, technical and regulatory support. All related production is to take place in Lonza's FDA registered facility in KouÃ…â„¢im, Czech Republic.
"This collaboration continues our efforts to produce liprotamase. Working together with Alnara we have reached an important milestone in the launch of liprotamase," saId Uwe Boehlke, chief operating officer at Lonza Custom Manufacturing, Exclusive Synthesis.
"We believe liprotamase will offer tremendous advantages to physicians and patients and has the potential to be the first significant advance to treat pancreatic insufficiency in 30 years," said Alexey Margolin, chief executive of Alnara Pharmaceuticals, which is based in Cambridge, Massachusetts, US.
Results from an international, Phase 3 study demonstrating the safety and nutritional benefits of liprotamase showed nutritional maintenance relative to the US population, which is a major finding for this historically challenged patient group. Approximately 90% of cystic fibrosis patients receive PERT to improve nutritional status and bowel-related symptoms related to pancreatic insufficiency. Overall health in people living with pancreatic insufficiency is directly related to their nutritional status and survival.