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October 15, 2001
Neurochem receives $1.4 Million grant from FDA and OMP designation in Europe for
Fibrillex.
Orphan Drug Designation already granted in U.S.
Neurochem Inc. (TSX : NRM) announced today that it received a CDN$1.4 million grant from the
Food and Drug Administration (FDA) in the U.S. for a pivotal Phase II/III study of
Fibrillex, which is currently underway. The Company also received Orphan Medicinal
Product (OMP) designation in Europe for its lead drug candidate, Fibrillex, for the
treatment of Secondary Amyloidosis. About Secondary Amyloidosis
Secondary Amyloidosis is a systemic and fatal form of amyloidosis. The disease is caused by
the deposition of amyloid A (AA) protein mainly in the kidneys, the spleen, the liver and
the adrenals causing severe dysfunction. It is associated with chronic inflammatory conditions
such as rheumatoid arthritis, chronic infections and with Familial Mediterranean Fever. The
estimated worldwide patient population with secondary amyloidosis is approximately half
a million, with no amyloid-specific treatment available yet. Clinical Trial Recruitment
Neurochem has put in place a multilingual recruitment and information program for providers
and patients touched by Secondary Amyloidosis. For further information regarding the trial or
to obtain brochures, you may call 1-866-234 AMYL (2695) in North America or visit Neurochem
on-line at www.neurochem.com. About Neurochem
Neurochem is an industry leader in the development of products for central nervous system and
amyloid-related diseases associated with aging. The Company has developed a novel, proprietary
series of compounds that inhibit the formation, deposition and toxic effects of amyloid
fibrils within the body. Neurochem's research and clinical teams are best known for their
development of therapeutic and diagnostic drug candidates for 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 70 people and is located in Saint-Laurent, Canada (www.neurochem.com).
All of the statements contained in this news release, other than statements of fact which
are independently verifiable at the date hereof, are forward-looking statements. Such
statements, based as they are on the current expectations of management, inherently involve
numerous risks and uncertainties, known and unknown. Some examples of known risks are: the
impact of general economic conditions, general conditions in the pharmaceutical industry, changes
in the regulatory environment in the jurisdictions in which Neurochem does business, stock
market volatility, fluctuations in costs, and changes to the competitive environment due to
consolidation or otherwise. Consequently, actual future results may differ materially from
the anticipated results expressed in the forward-looking statements.
For further Information, please contact: |
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