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September 28, 2006
Neurochem Marketing Authorization Application for Kiacta™ accepted for review by EMEA About Kiacta™
Kiacta™ was investigated in a landmark international, randomized, double-blind, placebo-controlled, and
parallel-designed clinical trial in which 183 patients were enrolled at 27 sites around the world. Patients who
completed the clinical trial were eligible for enrollment in an ongoing open-label extension study. About Amyloid A (AA) amyloidosis
A progressive and fatal condition, AA amyloidosis occurs in a proportion of patients with chronic inflammatory
disorders, chronic infections and inherited diseases such as Familial Mediterranean Fever. The kidney is the organ most
frequently affected and progression to dialysis and end stage renal disease is the most common cause of death in this
disease. Currently, there is no approved therapy to treat AA amyloidosis and about half of all patients diagnosed with the
disease die within five years of diagnosis. About Neurochem
Neurochem Inc. is focused on the development and commercialization of innovative therapeutics to address critical unmet
medical needs. Eprodisate (Kiacta™) is currently being developed for the treatment of AA amyloidosis, and is
under regulatory review for marketing approval by the U.S. Food and Drug Administration and European Medicines Agency.
Tramiprosate (Alzhemed™), for the treatment of Alzheimer's disease, is currently in Phase III clinical trials in
both North America and Europe and tramiprosate (Cerebril™), for the prevention of Hemorrhagic Stroke caused by
Cerebral Amyloid Angiopathy, has completed a Phase IIa clinical trial. To Contact Neurochem
For additional information on Neurochem and its drug development programs, please call the North American toll-free number
1 877 680-4500 or visit our Web Site at: www.neurochem.com.
This news release contains forward-looking statements regarding eprodisate (Kiacta™), as well as regarding
continuing and further development efforts. These statements are based on the current analysis and expectations of
management. Drug development necessarily involves numerous risks and uncertainties, which could cause actual results
to differ materially from this current analysis and these expectations. Analysis regarding the results of clinical
trials may not provide definitive results regarding safety, tolerability or therapeutic benefits. Even if all the
endpoints sought in the clinical trials were met (which is not certain), there is no certainty that regulators would
ultimately approve eprodisate (Kiacta™) for sale to the public. Risks and uncertainties may include: failure to
demonstrate the safety, tolerability and efficacy of our product, the expense and uncertainty of obtaining regulatory
approval, including from the FDA, and the possibility of having to conduct additional clinical trials. Further, even
if regulatory approval is obtained, therapeutic products are generally subject to: stringent on-going governmental
regulation, challenges in gaining market acceptance, and competition. Neither Neurochem Inc., nor Neurochem
(International) Limited undertake any obligation to publicly update any forward-looking statements, whether as a
result of new information, future events, or otherwise. Please see Neurochem Inc.'s Annual Information Form for
further risk factors that might affect Neurochem Inc., Neurochem (International) Limited and their respective
businesses.
For further Information, please contact: |
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