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August 22, 2005
Neurochem initiates submission of NDA with the U.S. FDA for Fibrillex™ in AA Amyloidosis. About Fibrillex™
Fibrillex™ is an oral investigational product candidate for the treatment of AA Amyloidosis through the
prevention of amyloid fibril formation. In 1999 Fibrillex™ received U.S. Orphan Drug Designation, in 2001 the
Orphan Medicinal Product (OMP) designation in Europe, in 2004 the Fast Track Designation in the U.S. and was
accepted into the Pilot 2 and Pilot 1 programs by the FDA's Division of Cardio-Renal Drug Products in 2004
and 2005, respectively. 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 two to ten 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 product candidates 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 the FDA Continuous Marketing Applications Pilot 1 and Pilot 2 programs. The Phase II/III
clinical trial of Fibrillex™ for the treatment of AA Amyloidosis was recently concluded. The Company is in the
process of submitting a New Drug Application (NDA) for Fibrillex™ that the FDA has agreed to file and review.
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. There can be no assurance
that any regulator 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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