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December 22, 2004
Neurochem Inc. announces the signing of exclusive collaboration and distribution agreement for
Fibrillex with Centocor, Inc. About Fibrillex
Fibrillex, an oral product candidate for the treatment of AA Amyloidosis, prevents amyloid fibril formation.
Fibrillex belongs to the class of glycosaminoglycan (GAG) mimetics, better known as amyloid disease-modifiers. By
mimicking GAGs, Fibrillex prevents formation of the AA fibrils and their deposition in affected tissues, which, when
left untreated, leads to organ failure. About AA Amyloidosis
AA Amyloidosis is a progressive and fatal condition that affects some 270,000 people around the world and 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, abdominal pain and malabsorption. Enlargement of the
liver and the spleen may also occur in some patients. About Neurochem
Neurochem Inc. 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 the study data are expected
to be released in the second quarter of 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 II 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.
Certain statements contained in this news release, other than statements of fact that are independently verifiable at
the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current
expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are
beyond Neurochem Inc.'s control. Specifically, the financial terms of this agreement, including payment of milestones
and distribution fees, depend upon the results of the Phase II/III clinical trials, the approval for the commercial sale
of Fibrillex by the US Food and Drug Administration, the European Medicines Evaluation Agency and other similar
regulatory authorities and upon the volume of sales of Fibrillex over the life of the agreement. The risks also
include but are not limited to: the impact of general economic conditions, general conditions in the pharmaceutical
industry, changes in the regulatory environment in the jurisdictions in which Neurochem Inc. does business, stock
market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, as well as
other risks disclosed in public filings of Neurochem Inc. Consequently, actual future results may differ materially from
the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance on, if
any, the forward-looking statements included in this news release. These statements speak only as of the date made
and Neurochem Inc. is under no obligation and disavows any intention to update or revise such statements as a result
of any event, circumstances or otherwise.
For further Information, please contact: |
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