Lonza will also provide additional regulatory support for NDA filing of nonporcine drug.
Lonza signed an agreement with Alnara Pharmaceuticals to manufacture the latter’s pancreatic enzyme replacement therapy (PERT), liprotamase. It is is currently being prepared for an NDA filing.
Under the terms of the agreement, Lonza will provide microbial fermentation and process optimization as well as technical and regulatory support for liprotamase. Production of the drug will be carried out at the company’s FDA-registered facility in the Czech Republic.
Alnara’s liprotamase is an oral, nonporcine PERT for the treatment of maldigestion, malabsorption, and malnutrition resulting from exocrine pancreatic insufficiency associated with conditions including cystic fibrosis, chronic pancreatitis, pancreatic cancer, and other pancreatic conditions. Positive data from the Phase III long-term safety and nutritional benefits study were due for presentation at the “North American Cystic Fibrosis Conference” held between October 15 and 17.
Liprotamase may represent the first significant advance in the treatment of pancreatic insufficiency in 30 years, according to Alnara’s president and CEO, Alexey Margolin, Ph.D. “Now that we have completed the liprotamase clinical development program, this agreement supports our commercialization efforts as we prepare to submit an NDA and bring this product directly to pancreatic insufficiency patients living with cystic fibrosis and other diseases.”