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April 10, 2003
Neurochem's Data Safety Monitoring Board recommends continuation of pivotal phase II/III
clinical trial for Fibrillex™. About Fibrillex™
The pivotal Phase II/III clinical trial for Fibrillex™ is a two-year, international,
multicenter, randomized, double-blind, placebo-controlled, and parallel-designed trial to
evaluate the safety and efficacy of Fibrillex™ in patients suffering from secondary AA
amyloidosis. Neurochem has successfully completed the enrollment of more than the 150 patients
required for this pivotal Phase II/III trial, which is being conducted at 27 sites located
across North America, Europe and Israel. This trial is planned to end in January 2005. About Secondary AA Amyloidosis
Secondary AA amyloidosis is associated with chronic inflammatory diseases (e.g., rheumatoid
arthritis, ankylosing spondylitis, inflammatory bowel diseases), chronic infections (e.g.,
osteomyelitis, tuberculosis) and Familial Mediterranean Fever. The most common clinical
presentation of secondary AA amyloidosis is kidney malfunction. 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. Secondary AA amyloidosis has a poor
prognosis with five- to 15-year survival rates of 50% and 25%, respectively. End-stage renal
failure is the cause of death in 40% to 60% of cases. There is currently no therapy for the
direct treatment of secondary amyloidosis. About Neurochem
Neurochem is a product-driven, specialty pharmaceutical company which offers a new class
of drug candidates to prevent and stop the progression of diseases for which no cure
exists. The Company's strong and growing pipeline will meet unmet medical needs and is
focused on disorders of the central nervous system and amyloid-related diseases. Neurochem's
most advanced product candidate is Fibrillex™, in pivotal Phase II/III clinical
development for the treatment of Secondary Amyloidosis, a fatal kidney disease. Two other
product candidates in Phase II clinical development are Alzhemed™ for the treatment
of Alzheimer's disease and Cerebril™ for Hemorrhagic Stroke due to Cerebral Amyloid
Angiopathy. At the pre-clinical development stage, the Company has two potential products
targeting Diabetes Type 2 and Epileptic Seizures induced by traumatic brain
injury (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.
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