Newsroom 2005
Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) announced today that it has launched its European Phase III clinical trial
on Alzhemed™, following an investigators' meeting attended by more than 250 clinicians and health professionals in
Vienna, Austria, from September 9 to September 11, 2005. Alzhemed™ is the Company's investigational product
candidate for the treatment of Alzheimer's disease (AD). There are 73 centers in ten countries which have been
selected by Neurochem to conduct the trial, of which many are centres of excellence of the European Alzheimer's Disease
Consortium (EADC).
The multi-centre, randomized, double-blind, placebo-controlled and parallel designed European Phase III clinical trial
will investigate the safety and efficacy of Alzhemed™ in treating AD, with some 930 mild-to-moderate AD patients
taking part in the trial. They will be randomized to receive either placebo or one of two different dose levels of
Alzhemed™ for a period of 18 months, in addition to their regular treatment with one of a number of
acetylcholinesterase inhibitors.
In July, Neurochem completed the enrolment of 1052 mild-to-moderate AD patients for its North American Phase III
clinical trial on Alzhemed™. To date, approximately 470 and 210 patients have completed six and nine months of
the North American trial, respectively. Both the European and North American trials are designed to demonstrate
the disease-modifying potential of Alzhemed™.
"This Phase III clinical trial for Alzhemed™ is, in my view, the one raising the most hope in Europe for the
treatment of Alzheimer's disease," said Bruno Vellas, MD, Ph.D., Professor of Medicine and Chairman of the
Department of Internal Medicine and Geriatric Medicine, and Chief of the Alzheimer's Disease Clinical and Research
Center at the University Hospital Center in Toulouse, France, and one of the Principal Investigators of Alzhemed™'s
Phase III clinical trial in Europe for the EADC.
"Alzhemed™'s good tolerability profile and unique mechanism of action aimed at stopping the progression of
the disease rather than targeting the symptoms are particularly interesting. The enthusiasm evidenced by the large
attendance at our recent investigator meeting in Vienna for this Phase III illustrates the European medical community's
interest in and the excitement about participating in this trial," he added.
"We are excited that Alzhemed™ is potentially first in a new class of orally-available therapeutics developed
to stop the progression of the disease," said Denis Garceau, Ph.D., Senior Vice President, Drug Development at
Neurochem. He added that, "We are proud to collaborate during this Phase III clinical trial with eminent European
leaders in the AD field - medical experts such as Professor Vellas - who are eager to find a treatment for this
debilitating disease."
About Alzhemed™
Azhemed™ is an orally administered, small organic molecule specifically designed to modify the course of AD
by binding to soluble amyloid ß (Aß) protein and keeping it in a non-fibrillar form. As reported previously, results
of the Phase II trial demonstrated that there were no apparent safety findings of concern in patients treated with
Alzhemed™ and that the investigational product candidate was well tolerated in individuals with mild-to-moderate
AD.
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 includesUS$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 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. The Company is in the process of submitting
a New Drug Application (NDA) for Fibrillex™ that the FDA has agreed to file and review. 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. 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
