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September 11, 2000
Neurochem Inc. files "IND" Submission to FDA for lead candidate in
treatment of Secondary Amyloidosis
Neurochem Inc. (TSX : NRM) today announced that it has submitted an Investigational New Drug
(IND) application for its lead drug candidate Fibrillex™ to the U.S. Food and
Drug Administration (FDA). The regulatory IND submission precedes the initiation of the
pivotal Phase II/III clinical trials. Fibrillex™ is being developed as
an orally active anti-amyloid agent for patients suffering from Secondary Amyloidosis.
" This IND submission is a very important step in the drug development process and brings
Fibrillex™ one step closer to becoming a safe and efficacious treatment against
Secondary Amyloidosis," said Dr. Louis R. Lamontagne, President and Chief Executive
Officer of Neurochem. "Fibrillex™ has an orphan drug designation and
represents the lead product at Neurochem, establishing in the scientific and medical
community a « proof-of-concept » of our core anti-amyloid technology currently
being applied by our scientists to widely known diseases including Alzheimer's disease,
Diabetes, and Hemorrhagic Stroke due to Cerebral Amyloid Angiopathy," he added.
Secondary Amyloidosis is a systemic and fatal form of amyloidosis associated with chronic
diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis,
Crohn's disease and Familial Mediterranean Fever. It is estimated that more than 500,000
patients in industrialized countries are presently suffering from Secondary Amyloidosis,
with no specific treatment available.
In April 1999, Neurochem was granted « Orphan Drug Designation » Status for
Fibrillex™ by the FDA, conferring a seven-year U.S. market exclusivity to the
Company for Fibrillex™. Fibrillex™ has successfully completed four
Phase I safety clinical trials, including a trial in subjects with varying degrees of
impairment of kidney function. "Fibrillex™ was very well tolerated in
healthy and renal impaired subjects and exhibited a good pharmacokinetic profile in both
subject groups", said Dr. Denis Garceau, Vice-President, Drug Development, at
Neurochem.
Neurochem is an industry leader in the development of a novel, proprietary series of
compounds that inhibit the formation, deposit and toxic effects of amyloid fibrils on
cells within the body. Neurochem's research team has been working with international
amyloid experts on the development of therapeutic cures to amyloid-related diseases,
including Alzheimer's disease, Secondary Amyloidosis , Diabetes Type II and Hemorrhagic
Stroke (due to Cerebral Amyloid Angiopathy). Neurochem has advanced three drug candidates to
clinical trials: Alzhemed™, for the treatment of Alzheimer's disease,
Fibrillex™, for Secondary Amyloidosis, and Cerebril™, for
Hemorrhagic Stroke. At present, the Company employs over 50 people and is located in
Saint-Laurent, Canada (www.neurochem.com).
For further Information, please contact:
Dr. Lise Hébert
Vice President, Corporate Communications
lhebert@neurochem.com
275 Armand-Frappier
Laval (Quebec)
H7V 4A7
Tel: (450) 680-4500
Fax: (450) 680-4501
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