DSM BioSolutions to manufacture Mayoly Spindler's 'MS1819' lipase biotherapeutic

DSM BioSolutions today announced that it has entered into an agreement with Laboratoires Mayoly Spindler, Chatou Cedex, France, for the manufacture of "MS1819" lipase.

DSM has successfully completed process development and commenced cGMP manufacture of the Mayoly Spindler lipase compound for pre-clinical and Phase I clinical needs. DSM BioSolutions manufactures the lipase compound at its microbial fermentation facility located in Capua, Italy. DSM's Capua facility is uniquely equipped for the production of microbial fermentation derived biological compounds, and has extensive experience in fungal and bacterial fermentations.

Villaume Kal, Vice-President DSM BioSolutions stated, "We are delighted to work with Mayoly Spindler on this new, promising compound. Our technology, operational excellence and outstanding record with the FDA allow us to serve this important customer."

"We are pleased to form this partnership with DSM BioSolutions for producing our new Lipase biotherapeutic," stated Jean-Nicolas Vernin, President of Mayoly Spindler. 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 United States 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," Mr. Vernin added.