Altus Pharmaceuticals Reaffirms Plan to Submit New Drug Application for Trizytek Approval
Monday November 17, 9:29 am ET
WALTHAM, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News) announced today that it is reaffirming its plan to submit a new drug application (NDA) for Trizytek TM (liprotamase) in the first-half of 2009. Trizytek is a non-porcine derived enzyme replacement therapy for patients with pancreatic insufficiency.
Based on a positive FDA 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 for Trizytek. In the pre-NDA meeting package, Altus provided the FDA comprehensive data from its completed Phase 3 efficacy and Phase 2 studies as well as interim safety and health-outcomes data from the ongoing Phase 3 studies 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 Trizytek is no longer necessary and Altus’ previously stated timelines for the Trizytek NDA submission remain unchanged.
“With this communication from the FDA, we are reaffirming our goal of filing a new drug application for Trizytek in the first half of 2009. 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 Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. “The outcome from our discussions with the FDA only strengthens our belief in the clinical benefit that Trizytek will bring to patients who require pancreatic enzyme replacement therapy. In addition, completing a corporate collaboration around Trizytek is key to our plan going forward and we believe this information will be an important part of the evaluation of the program by any potential partner.”
Altus’ Phase 3 Trizytek efficacy trial in patients with cystic fibrosis (CF) successfully met its primary endpoint of improvement in fat absorption with statistical significance. In August 2008, the Company released top-line results from its 163 patient, double-blind, placebo-controlled trial of Trizytek, which is a stable and pure combination of three active enzymes in a fixed-ratio that is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. (Click here to view the August 11, 2008 press release.) Trizytek was well-tolerated and had a favorable safety profile in the trial. There were no serious adverse events attributed to the Trizytek treatment. Altus’ Trizytek Phase 3 clinical program is the largest ever conducted to evaluate the efficacy and safety of pancreatic enzyme replacement therapy in cystic fibrosis patients.
surf's up......crikey
