Altus Pharmaceuticals signed a long-term agreement with Lonza to commercially manufacture Altus’ ALTU-135 drug substances at Lonza’s facility in Kouøím, Czech Republic.
ALTU-135, the company’s orally administered enzyme replacement therapy in development for patients with pancreatic insufficiency, is the drug product that results after blending three drug substance enzymes (protease, lipase, and amylase). The enzyme combination is designed to improve fat, protein, and carbohydrate absorption in pancreatic insufficient individuals, according to Altus. ALTU-135 is intended to replace missing digestive enzymes to promote and maintain proper digestion and growth in affected patients.
Earlier this week Altus said it plans to begin its ALTU-135 Phase III clinical trial in the second quarter of 2007. The company will continue to use its current contract manufacturer for the drug substances to be used in the ALTU-135 Phase III clinical trial. In preparation for the ALTU-135 commercial launch, Altus and Lonza will coordinate and manage the technology transfer as well as the installation and qualification of the key equipment necessary for the production of ALTU-135 while the Phase III trial is being conducted.