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DSM to Manufacture 'MS1819' Lipase Compound for Mayoly Spindler

Tuesday, December 22, 2009 Drug News J E 4
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CAPUA, Italy, Dec. 22 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.

No financial terms will be disclosed.

About Laboratoires Mayoly Spindler

Laboratoires Mayoly Spindler is a privately-owned French pharmaceutical company, founded in 1929, specializing in Gastroenterology. Laboratories Mayoly-Spindler recorded a EUR 125 million turnover in 2008. The company employs 470 people, has two pharmaceutical manufacturing plants in the area of Paris and is headquartered in Chatou Cedex (near Paris). More information: www.mayoly-spindler.com.

DSM BioSolutions - Microbial Fermentation

DSM BioSolutions, part of the DSM Pharma cluster, offers a wide range of customer services ranging from process development to large scale production, all in the field of microbial fermentation. Expertise covers microbial strain construction and improvement, fermentation process development and product recovery and purification. DSM's production infrastructure for fermentation and associated product recovery and purification is based in a multipurpose facility in Capua, Italy, which currently produces pharmaceutical intermediates and APIs (with the exception of beta-lactams) and food/nutrition-related products. In the pharma area, production lines are available for cGMP manufacturing of small molecules and pharmaceutical proteins. The facilities comply with all relevant regulations and are regularly inspected by the respective authorities (e.g. FDA). More information: www.dsmbiosolutions.com.

DSM - the Life Sciences and Materials Sciences Company

Royal DSM N.V. creates innovative products and services in Life Sciences and Materials Sciences that contribute to the quality of life. DSM's products and services are used globally in a wide range of markets and applications, supporting a healthier, more sustainable and more enjoyable way of life. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrical and electronics, life protection and housing. DSM has annual net sales of EUR 9.3 billion and employs some 23,500 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam. More information: www.dsm.com.

Forward-looking statements

This press release may contain forward-looking statements with respect to DSM's future (financial) performance and position. Such statements are based on current expectations, estimates and projections of DSM and information currently available to the company. DSM cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. DSM has no obligation to update the statements contained in this press release, unless required by law.

For more information: DSM BioSolutions Laboratoires Mayoly Spindler Villaume Kal Nathalie Masson Vice President R&D Director Tel: +31 15 279 2173 Tel: +33 (0) 34 804 449 Email: villaume.kal@dsm.com Email: nathalie.masson@mayoly-spindler.fr Fabio Velotti Sr, Account Director Tel: +39 (0) 823628310 Email: fabio.velotti@dsm.com

SOURCE DSM BioSolutions
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