FDAnews
www.fdanews.com/articles/75727-neurochem-initiates-submission-of-nda-for-fillibrex

NEUROCHEM INITIATES SUBMISSION OF NDA FOR FILLIBREX

August 24, 2005

Neurochem has initiated the submission of a "rolling" new drug application (NDA) to the FDA seeking marketing approval for its investigational product candidate, Fibrillex, for the treatment of Amyloid A (AA) Amyloidosis. Neurochem plans to complete the submission of the NDA at the end of the year.

AA Amyloidosis is a serious medical condition for which no specific treatment exists and frequently leads to organ dysfunction and subsequent death. Fibrillex is an oral investigational product candidate for the treatment of AA Amyloidosis through the prevention of amyloid fibril formation.