Altus to file Trizytek NDA 1st-half 2009

USA-based Altus Pharmaceuticals has reaffirmed its plan to submit a New Drug Application for Trizytek (liprotamase) in the first half of 2009. The product is a non-porcine derived enzyme replacement therapy for patients with pancreatic insufficiency.

Based on a positive Food and Drug Administration response to Altus' pre-NDA meeting submission material, Altus and the FDA have agreed that the Trizytek clinical development program supports submission of a license application. In this meeting package, the company provided the agency with comprehensive data from its completed Phase III efficacy and Phase II studies, as well as interim safety and health-outcomes data from the ongoing Phase III trials to evaluate the long-term safety of Trizytek over one year of open-label treatment in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. As a result, the November pre-NDA meeting for the drug is no longer necessary and Altus' previously-stated timelines for the Trizytek NDA submission remain unchanged.

"We are focusing our resources on moving all aspects of the Trizytek program forward, including the ongoing long-term safety study, which is on track to be completed in the first half of 2009," stated Georges Gemayel, chief executive of Altus.