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"We are naturally disappointed with this opinion for KIACTA(TM) as we areacutely aware of the needs of AA amyloidosis patients who have no specifictherapy presently available," said Dr. Francesco Bellini, Neurochem Inc.'sChairman, President and CEO. "In view of the clinical benefit KIACTA(TM) hasshown on the kidney function of patients, we are considering making a requestfor re-examination of the opinion which could lead to a decision as early asthe second quarter of 2008. We look forward to further productive interactionswith the EMEA," he concluded.
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U.S. New Drug Application (NDA)
In the U.S., Neurochem Inc. received an acknowledgement from the Food andDrug Administration (FDA) that the Company's response to the second approvableletter of July 2007 for the NDA for eprodisate (KIACTA(TM)) for the treatmentof AA amyloidosis is a complete, Class 2 response. The PDUFA (PrescriptionDrug User Fee Act) goal date by which the FDA is expected to render a decisionis April 2, 2008.
About eprodisate (KIACTA(TM))
Eprodisate (KIACTA(TM)) was investigated in an international, randomized,double-blind, placebo-controlled, and parallel-designed Phase II/III clinicaltrial in which 183 AA amyloidosis patients were enrolled at 27 internationalsites (Eprodisate for AA Amyloidosis Trial, EFAAT). Patients who completed theclinical trial were eligible for enrollment in an ongoing open-label extensionstudy, some of whom have now been receiving eprodisate (KIACTA(TM)) for morethan six years. Eprodisate (KIACTA(TM)) has received orphan drug status in theUnited States, the European Union and in Switzerland.
The Company also filed for marketing approval for eprodisate (KIACTA(TM))for the treatment of AA amyloidosis in Switzerland. A decision is expected in2008.
A progressive and fatal condition, AA amyloidosis occurs in a proportionof patients with chronic inflammatory disorders, chronic infections andinherited diseases such as familial Mediterranean fever. The kidney is theorgan most frequently affected and progression to dialysis/end-stage renaldisease is the most common clinical manifestation in this disease. Currently,there is no approved therapy to treat AA amyloidosis and about half of allpatients diagnosed with the disease die within five years of diagnosis.
About Neurochem Inc.
Neurochem Inc. is a global health company focused on the research,development and commercialization of products to provide innovative healthsolutions to patients suffering from serious diseases.
To Contact Neurochem Inc
For additional information on Neurochem and its drug development programs,please call the North American toll-free number 1 877 680-4500 or visit ourWeb Site at: www.neurochem.com.
Certain statements contained in this news release, other than statementsof fact that are independently verifiable at the date hereo
