Newsroom 2005
- Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) announced today that its Independent Safety Review Board (ISRB) has issued a
recommendation to continue the Company's North American Phase III clinical trial for Alzhemed™ for the treatment
of Alzheimer's Disease (AD).
"We are encouraged by the Independent Safety Review Board's recommendation and pleased that the study is
continuing as planned," said Denis Garceau, PhD, Senior Vice President, Drug Development. "With over 1,000
patients screened, the recruitment in North America is proceeding on schedule and the study 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 562 patients who have been monitored in
the trial for at least 12 weeks so far. After reviewing the safety information, the ISRB concluded that there were no
significant safety concerns to report in the study and 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: in preventing and stopping the formation and the
deposition of amyloid fibrils in the brain and in binding to soluble A(B) 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 the 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 brain's 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 Inc.'s control. The 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 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:
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
