DSM BioSolutions, part of the DSM Pharma cluster (Parsippany, N.J.; www.dsmbiosolutions.com) has announced that it has entered into an agreement with Laboratoires Mayoly Spindler (Chatou Cedex, France; www.mayoly-spindler.com), for the manufacture of “MS1819” lipase. DSM has completed process development and commenced cGMP manufacture of the Mayoly Spindler lipase compound at its microbial-fermentation facility located in Capua, Italy, for pre-clinical and Phase I clinical needs. The Capua facility is equipped for the production of microbial, fermentation-derived-biological compounds. No financial terms have been disclosed.
Lipase is an enzyme for the treatment of exocrine pancreatic insufficiency (EPI), the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. The lipase enzyme is designed to improve fat absorption in pancreatic insufficient patients. The estimated number of patients in the U.S. with EPI is more than 200,000. "Extensive preclinical studies support its potential therapeutic use for the treatment of patients with exocrine pancreatic insufficiency (EPI). We are optimistic about the promise of this new enzyme therapy and our goal to initiate clinical trials in early 2010," stated Jean-Nicolas Vernin, president of Mayoly Spindler.