Altus Pharmaceuticals (ALTU) Reaffirms Plan to Submit NDA for Trizytek in 1H09

November 17, 2008 9:49 AM EST

Altus Pharmaceuticals Inc. (NASDAQ: ALTU) announced today that it is reaffirming its plan to submit a new drug application 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.

Altus Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of oral and injectable protein therapeutics for gastrointestinal and metabolic disorders.

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