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April 18, 2005
Neurochem announces preliminary results of Phase II/III clinical study for Fibrillex. Next Steps
The company plans to complete its analysis of the Phase II/III data and present it to the FDA as soon as possible. It
also plans to present data at international medical conferences in the first half of 2005. Neurochem intends to honor
its commitment to continue to supply Fibrillex to any patient receiving the drug through the 24-month on-going
open-label extension study. Patients currently on Fibrillex should consult their physician about their on-going
treatment at the first opportunity. About Fibrillex
Fibrillex is an oral investigational product candidate for the treatment of AA Amyloidosis through the prevention
of amyloid fibril formation. 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. 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. 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
For further Information, please contact: |
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