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Altus, Lonza Sign Manufacturing Pact

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Altus Pharmaceuticals, Inc. has signed a long-term agreement with Lonza Group Ltd. for the commercial manufacture of its ALTU-135 drug substances at Lonza’s facility in Kourim, Czech Republic. ALTU-135 is an orally administered enzyme replacement therapy in development for patients with pancreatic insufficiency. The drug product that results after blending three drug substance enzymes: protease, lipase and amylase. This combination is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals and to promote and maintain proper digestion.

Altus plans to initiate a Phase III trial of ALTU-135 in the 2Q2007. Altus will use its current contract manufacturer for the drug substances to be used in the trial. In preparation for the commercial launch of ALTU-135, Altus and Lonza will coordinate the technology transfer as well as the installation and qualification of the equipment necessary for the production of the drug while the Phase III trial is being conducted.

“We are pleased to be collaborating with Lonza, which is an organization with significant expertise in biopharmaceutical production, microbial fermentation, process optimization and quality systems,” commented Sheldon Berkle, president and chief executive officer of Altus. “We believe selecting Lonza is a significant milestone for the ALTU-135 program. We continue to work towards putting the pieces in place for a successful ALTU-135 commercial launch.”

Lonza’s chief executive officer, Stefan Borgas, said, “Lonza is gratified to be partnering with Altus Pharmaceuticals and to be awarded this significant manufacturing agreement. We believe this relationship will significantly benefit both organizations and will ultimately result in a valuable therapy for patients in need.”

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