Newsroom 2005
Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) announced today that its Independent Safety Review Board (ISRB) has issued
a second recommendation to continue the Company's North American Phase III clinical trial for Alzhemed™, an
investigational product candidate for the treatment of Alzheimer's Disease (AD).
"This additional positive recommendation by the Independent Safety Review Board, reinforces our previous findings
on the safety and tolerability of Alzhemed™," said Denis Garceau, PhD, Senior Vice President, Drug
Development. "Over 900 patients have been enrolled and the trial is on track for completion as planned."
Neurochem's ISRB for Alzhemed™ is made up of independent medical experts who monitor and evaluate the safety
of patients taking part in the Alzhemed™ Phase III clinical trial in North America. The recommendation by the ISRB
members was based on their recent review of the safety data from 742 patients who have been treated with the medication
for an average of 12 weeks. After reviewing the safety information, the ISRB concluded that the trial should continue
as planned.
About Alzhemed™
Alzhemed™ is an orally administered, small organic molecule that has been specifically designed to modify the
course of AD through its anti-amyloid activity. As part of a "disease modifying" novel class of product
candidates, Alzhemed™ is expected to act at two levels: by preventing and stopping the formation and the
deposition of amyloid fibrils in the brain and by binding to soluble Aß protein to reduce the amyloid-induced
toxicity on neuronal and brain inflammatory cells associated with amyloid build-up in AD.
Alzhemed™ has entered into a multicenter, randomized, double-blind, placebo-controlled, three-armed, parallel-design
Phase III clinical trial; 68 clinical centers have been enrolled in North America. The study will include some 950
patients who will receive study medication over a period of 18 months. The Company anticipates launching its Phase III
trial in Europe in fall 2005.
About Alzheimer's Disease
AD is a leading cause of death in older people. The disease is characterized by the progressive death of nerve cells
in the brain, making it difficult for the neuronal signals to be transmitted properly. A person with AD experiences
problems with memory, judgment, thinking, and eventually with motor functions, which makes it hard for the person
to participate in day-to-day activities.
According to the National Institute on Aging's "Progress Report on Alzheimer's Disease, 2000," AD is the
most common cause of dementia among people aged 65 and older. Scientists estimate that up to four and a half million
people in the United States currently suffer with the disease and the prevalence (the number of people with the disease
at any one time) doubles every five years beyond age 65. It is also estimated that approximately 360,000 new cases
(incidence) will occur each year and that this number will increase as the population ages.
In a 2000 report, the Biotechnology Industry Organization estimated that in the United States the total cost of AD
has been estimated at US$100 billion per year.
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 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 preliminary results have been issued
in April 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 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.
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's control. Such risks 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 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. Consequently, actual future
results may differ materially from the anticipated results expressed in the forward-looking statements. The reader
should not place undue reliance, if any, on the forward-looking statements included in this news release. These
statements speak only as of the date made and Neurochem is under no obligation and disavows any intention to update
or revise such statements as a result of any event, circumstances 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:
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
