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June 22, 2006
Eprodisate (Fibrillex™) data presented at the meeting of the European League Against Rheumatism (Eular) About AA amyloidosis
AA amyloidosis is a progressive and fatal condition that occurs in a proportion of patients with long standing chronic
inflammatory disorders, chronic infections and inherited diseases such as Familial Mediterranean Fever. The kidney is
the organ most frequently affected by AA amyloidosis, and progression to dialysis and end-stage renal disease is the
most common cause of death in this disease. New approaches to treatment for AA amyloidosis are urgently needed due
to lack of specific therapies. About eprodisate (Fibrillex™)
Eprodisate (Fibrillex™) has been shown to reduce amyloid deposition in a mouse model of the disease. Results from
a completed Phase II/III clinical trial with AA amyloidosis patients found eprodisate (Fibrillex™) to have a
favorable clinical benefit on renal function/all-cause mortality. The product candidate was well tolerated and the
adverse events profile of eprodisate (Fibrillex™) was comparable to placebo. About regulatory submission status of eprodisate (Fibrillex™)
While there is no specific treatment approved for use, the new drug application for eprodisate (Fibrillex™) for
the treatment of AA amyloidosis has been filed and received priority review by the US Food and Drug Administration (FDA)
last April. The FDA is expected to render a decision on eprodisate (Fibrillex™) around mid-August 2006. Neurochem
expects to submit a Marketing Authorization Application to the European Medicines Agency (EMEA) in the fall of 2006. About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics to address critical unmet
medical needs. Eprodisate (Fibrillex™) is designated as an orphan drug, is a Fast Track product candidate and is
also part of the US Food and Drug Administration (FDA) Continuous Marketing Application Pilot 1 and Pilot 2 programs.
In April 2006, the FDA filed and granted the eprodisate (Fibrillex™) new drug application priority review.
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 (Fibrillex™), 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 (Fibrillex™) 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. Neurochem does not undertake any obligation
to publicly update its forward-looking statements, whether as a result of new information, future events, or
otherwise. Please see the Annual Information Form for further risk factors that might affect the Company and
its business.
For further Information, please contact: |
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