Neurochem moves eprodisate (KIACTA(TM)) drug development program forward for Amyloid A amyloidosis
Thursday March 13, 7:00 am ET
ECUBLENS, SWITZERLAND, March 13 /PRNewswire-FirstCall/ - Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX - News; TSX: NRM - News), announces that the Company is taking new initiatives to pursue the drug development program for its investigational product candidate, eprodisate (KIACTA(TM)), to obtain market approval for the treatment of Amyloid A (AA) amyloidosis. Neurochem's decision to build upon its eprodisate (KIACTA(TM)) asset and take steps to initiate a second Phase III clinical trial is based principally on the fact that AA amyloidosis is a life-threatening disease for which there is no specific treatment, on the data obtained from the first Phase II/III clinical trial, which yielded promising efficacy results on the study endpoints, on the benign safety profile of eprodisate (KIACTA(TM)) in patients diagnosed with AA amyloidosis, and on its discussions with the regulatory agencies and related scientific advisory committees. As part of the approval process for the investigational product candidate, both the regulatory agencies in the United States and in the European Union recommended an additional confirmatory efficacy Phase III clinical trial, which will have a target significance level (p-value) of 0.05 rather than the p-value of 0.01, which had been required for an approval based on a single efficacy study. Based on these recommendations, the Company will enter into discussions with the U.S. Food and Drug Administration (FDA) and with the European Medicines Agency (EMEA) to reach agreement on the terms for an approval of eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis. As part of this strategic decision, the Company is also announcing that it is withdrawing its current marketing applications for eprodisate (KIACTA(TM)) in the United States, the European Union and Switzerland.
surf's up......crikey
