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June 5, 2005
New Fibrillex™ Data Presented at the European Renal Association-European Dialysis and Transplant
Association Meeting. Secondary Endpoints
Analysis of secondary efficacy endpoints in Neurochem's trial, including progression to end-stage renal
disease/dialysis and slope of decline of creatinine clearance, point in favor of Fibrillex™ reducing the risk of
renal decline events in AA Amyloidosis patients. Safety Data
The data suggest Fibrillex™ is well tolerated. The most frequent adverse events experienced by the patients in
this study were of gastrointestinal origin and infections. The incidence of treatment-emergent adverse events (all
causalities) in patients on Fibrillex™ was comparable to placebo. About Fibrillex™
Fibrillex™ is an oral investigational product candidate for the treatment of AA Amyloidosis through the
prevention of amyloid fibril formation. It has received Orphan Drug Status designation in the United States
and Orphan Medicinal Product designation in Europe. About AA Amyloidosis
AA Amyloidosis is a progressive and fatal condition that occurs in a proportion of patients with chronic inflammatory
diseases, including rheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, and Crohn's disease.
The disease also occurs in patients suffering from many other conditions ranging from chronic infections to inherited
inflammatory diseases such as Familial Mediterranean Fever. The most common clinical presentation of AA Amyloidosis
is renal dysfunction. Involvement of the gastrointestinal system is also frequent and is usually manifested as chronic
diarrhea, gastrointestinal bleeding, abdominal pain and malabsorption. Enlargement of the liver and the spleen may
also occur in some patients. End-stage renal failure is the main cause of death in 40-60% of cases. The median
survival time from diagnosis varies from 2 to 10 years depending on the stage of the disease at the time
of diagnosis. About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics for neurological disorders.
The Company's pipeline of proprietary, disease-modifying oral products addresses critical unmet medical needs.
1,3-propanedisulfonate (1,3PDS; Fibrillex™) is designated as an orphan drug and a Fast Track Product candidate
and is also part of an FDA Continuous Marketing Applications Pilot 2 program. The Phase II/III clinical trial of
Fibrillex™ for the treatment of AA Amyloidosis was recently concluded and preliminary results have been issued
in April 2005. 3-amino-1-propanesulfonic acid (3APS; Alzhemed™), for the treatment of Alzheimer's Disease, is in
a Phase III clinical trial and 3APS (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 Fibrillex™, as well as 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 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. Additionally, 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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