Replies to post #68648 on Biotech Values

[marthambles]

Press Release Source: Altus Pharmaceuticals

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.
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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.”

I must admit, I have no idea how this affects approval chances, but at its current price, any material improvement in its chances would make this an interesting speculation.