Neurochem announces European opinion for Eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis

18-Dec-2007

Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc., announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a negative opinion recommending refusal of the marketing authorization application (MAA) for eprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis and concluding that another study would be needed to demonstrate eprodisate's (KIACTA(TM)) effectiveness. The Company is currently reviewing all of its options in view of this opinion, including the option of requesting a re-examination of the opinion by CHMP. As provided by the European regulations, the Company may request that the CHMP consult a Scientific Advisory Group (SAG) in connection with the re-examination. The deadline for filing any such request is within fifteen days of receipt of notification of the opinion.

"We are naturally disappointed with this opinion for KIACTA(TM) as we are acutely aware of the needs of AA amyloidosis patients who have no specific therapy presently available," said Dr. Francesco Bellini, Neurochem Inc.'s Chairman, President and CEO. "In view of the clinical benefit KIACTA(TM) has shown on the kidney function of patients, we are considering making a request for re-examination of the opinion which could lead to a decision as early as the second quarter of 2008. We look forward to further productive interactions with the EMEA," he concluded.

Eprodisate (KIACTA(TM)) was investigated in an international, randomized, double-blind, placebo-controlled, and parallel-designed Phase II/III clinical trial in which 183 AA amyloidosis patients were enrolled at 27 international sites (Eprodisate for AA Amyloidosis Trial, EFAAT). Patients who completed the clinical trial were eligible for enrollment in an ongoing open-label extension study, some of whom have now been receiving eprodisate (KIACTA(TM)) for more than six years. Eprodisate (KIACTA(TM)) has received orphan drug status in the United States, the European Union and in Switzerland.

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