Newsroom 2006
Attention Business/Financial/Health Editors:
Neurochem receives fourth recommendation from Independent Safety Review Board for Alzhemed(TM)
LAVAL, QC, Feb. 21 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)
announced today that its Independent Safety Review Board (ISRB) has issued a
fourth recommendation to continue the Company's North American Phase III
clinical trial for tramiprosate (Alzhemed(TM)) for the treatment of
Alzheimer's disease (AD).
Neurochem's ISRB for Alzhemed(TM) is made up of independent clinical
experts who monitor and evaluate the safety of patients taking part in the
Alzhemed(TM) Phase III clinical trial in North America and who perform related
analyses on the safety of those patients. The recommendation of the ISRB
members was based on their recent review of the available safety data of all
1,052 patients who have been on study medication for an average of eight
months.
Alzhemed(TM) is a small, orally-administered molecule designed to modify
the course of AD as an amyloid beta antagonist by binding to soluble amyloid
beta peptide to inhibit or reduce amyloid deposition.
About Alzheimer's Disease
Alzheimer's disease (AD) is a progressive form of dementia associated
with specific brain pathologies. It impairs a person's cognitive and motor
functions and gradually destroys the brain.
AD is the most common cause of dementia in our aging population. Almost
5 million individuals in the United States alone currently suffer from the
condition. The U.S. Alzheimer's Association estimates that by 2025, over
22 million people worldwide will be afflicted.
According to a report commissioned by the U.S. Alzheimer's Association,
AD costs American businesses approximately US$61 billion a year. That price
tag includes US$24.6 billion for direct health care of Alzheimer's patients
and US$36.5 billion to cover costs related to caregivers of AD patients,
including lost productivity, absenteeism and worker replacement.
About Neurochem
Neurochem is focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(Fibrillex(TM)) is designated as an orphan drug, is a Fast Track product
candidate and is also part of FDA Continuous Marketing Application Pilot 1 and
Pilot 2 programs. The Phase II/III clinical trial of Fibrillex(TM) for the
treatment of AA amyloidosis was concluded in April 2005. The Company has
completed its submission of a New Drug Application for Fibrillex(TM) that the
FDA agreed in June 2005 to file and review. Tramiprosate (Alzhemed(TM)), for
the treatment of Alzheimer's disease, is currently in Phase III clinical
trials in both North America and Europe and tramiprosate (Cerebril(TM)), 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.
This news release contains forward-looking statements regarding
tramiprosate (Alzhemed(TM)) as well as regarding continuing and further
development efforts. These statements are based on the current analysis and
expectations of management. Drug development necessarily involves numerous
risks and uncertainties, which could cause actual results to differ materially
from this current analysis and these expectations. Analysis regarding the
results of clinical trials may not provide definitive results regarding
safety, tolerability or therapeutic benefits. Even if all the endpoints sought
in the clinical trials were met (which is not certain), there is no certainty
that regulators would ultimately approve Alzhemed(TM) for sale to the public.
Risks and uncertainties may include: failure to demonstrate the safety,
tolerability and efficacy of our product, the expense and uncertainty of
obtaining regulatory approval, including from the FDA, and the possibility of
having to conduct additional clinical trials. Further, even if regulatory
approval is obtained, therapeutic products are generally subject to: stringent
on-going governmental regulation, challenges in gaining market acceptance, and
competition. Neurochem does not undertake any obligation to publicly update
its forward-looking statements, whether as a result of new information, future
events, or otherwise. Please see the Annual Information Form for further risk
factors that might affect the Company and its business.
For further information: Lise Hébert, PhD, Vice President, Corporate
Communications, 1-450-680-4570, lhebert@neurochem.com
