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Neurochem reports results for fourth quarter and fiscal year 2007 and important advances on corporate objectives
Date:2/20/2008

tration (FDA), the amount would no longer be refundable and would be amortized as earned revenue.

In December 2007, the Company received an acknowledgement from the FDA that Neurochem's response to the approvable letter received in July 2007 for the New Drug Application (NDA) for eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis is a complete, Class 2 response. The PDUFA (Prescription Drug User Fee Act) goal date by which the FDA is expected to render a decision is April 2, 2008. In the second approvable letter (July 2007), the FDA indicated that an additional efficacy trial will be necessary before the FDA could approve the investigational product candidate. The approvable letter also states that additional submissions, filed by Neurochem as part of its response to this approvable letter, may address issues raised in this letter. The FDA has indicated that additional submissions could persuade the agency to eliminate the requirement for an additional trial. The FDA also asked for additional information, including further pharmacokinetic studies, and again acknowledged that a QT clinical study should be submitted as part of a Phase IV (post-approval) commitment.

Neurochem has also submitted for marketing approval eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis in the European Union and Switzerland. In December 2007, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a negative opinion recommending refusal of the marketing authorization application (MAA) for eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis in the European Union and concluded that another study would be needed to demonstrate eprodisate's (KIACTA(TM)) effectiveness. The Company requested a re-examination of the opinion by CHMP. As provided by the European regulations, the Company requested that the CHMP consult a Scientific Advisory Group in connection with the re-examination.
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SOURCE NEUROCHEM INC.
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