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June 21, 2004
Neurochem announces the launch of North American Phase III clinical trial on
Alzhemed™ for the treatment of Alzheimer's Disease.
- Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) announced today that it has launched its North American Phase
III clinical trial on Alzhemed™, following an investigators' meeting attended by more than 200
clinicians and clinical monitors held in Montreal from June 18 to June 20, 2004. Alzhemed™ is
the Company's investigational product candidate for the treatment of Alzheimer's Disease (AD). The
trial will be conducted by 50 U.S. and 20 Canadian clinical centers across North America.
The multi-center, randomized, double-blind, placebo-controlled and parallel design North American Phase
III clinical trial will investigate the safety and efficacy of Alzhemed™ for the treatment of AD
in approximately 950 mild-to-moderate patients. The patients will be randomized to receive either
placebo or one of two different dose levels of Alzhemed™ for a period of 18 months. The Company
anticipates launching its Alzhemed™ European Phase III clinical trial early in 2005.
"We are on schedule for the launch of our Phase III clinical trial program on
Alzhemed™," said Dr. Francesco Bellini, Chairman and CEO of Neurochem. "We are
encouraged by the interest shown by the medical community in this Phase III trial and by the
attendance at the investigators meeting by clinicians from all 70 sites to ensure that the trial
protocol is well harmonized throughout all of North America. The results of our Phase II clinical
trial and our on-going open-label Phase II extension study appear to indicate that Alzhemed™
addresses not only the symptoms, but also has the potential to affect the progression of the
disease, especially in mild AD patients," he added.
Alzhemed™ is an orally administered, small organic molecule that has been specifically designed
to modify the course of AD by binding to amyloid ß (Aß) protein and keeping it in a
non-fibrillar form. As part of a "disease modifying" class of product candidates,
Alzhemed™ is expected to act at two levels: in preventing and stopping the formation and
deposit of amyloid fibrils in the brain and in inhibiting the inflammatory response associated with
amyloid build-up in AD.
"The most promising target in AD therapeutics is the amyloid peptide," said Dr. Paul
Aisen, Alzhemed™ principal investigator for the U.S. clinical sites and Professor of Neurology
and Medicine, and Director, Memory Disorders Program, at Georgetown University Medical Center in
Washington, D.C. "This investigational product candidate has been shown in preclinical development
to target the amyloid peptide. Neurochem's Phase II study demonstrated that Alzhemed™ is well
tolerated in individuals with AD. Furthermore, the majority of patients receiving Alzhemed™ for
a very long period in the open-label extension study, that is, for up to 16 months, have shown stable
cognitive function tests, especially in the mild population."
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. Furthermore, Alzhemed™ was detected in the
cerebrospinal fluid of the patients, suggesting its ability to cross the blood-brain-barrier and its
potential to act on amyloid, the underlying pathology of AD. The patients with the greatest decrease
of amyloid protein, as measured by immunoassays, were on Alzhemed™ and the majority of mild AD
patients on the highest dose showed stable or improved results on cognitive function tests even after
16 months of follow-up.
"Neurochem's study on Alzhemed™ could offer new hope for the thousands of people afflicted
with Alzheimer's disease", said Dr. Serge Gauthier, Alzhemed™ principal investigator for
the Canadian sites and Professor of Neurology and Neurosurgery, Psychiatry, Medicine and Associate
Member of Pharmacology and Therapeutics at McGill University in Montreal, Canada. "The outcome
measures during treatment with Alzhemed™ will accurately evaluate the daily life of participants
and their families, as well as the biological changes associated with the disease."
About Alzheimer's Disease
Alzheimer's disease (AD) is a brain disorder in which nerve cells in the brain die, making it
difficult for the brain's signals to be transmitted properly. A person with AD has problems with
memory, judgment, thinking, and eventually with motor functions, making it difficult for the person
to work or continue to take part in day-to-day life.
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. It presents a major health
problem because of its enormous impact on individuals, families, the health care system, and society
as a whole. Scientists estimate that up to four and a half million people in the United States
alone 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 in the United States and that this number will
increase as the population ages.
In a 2000 report, the Biotechnology Industry Organization (BIO) estimated that AD is becoming the
most widespread and costly age-related disorder in the United States: total cost of the disease
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. Fibrillex™, designated as an orphan drug and as a Fast
Track Product candidate, is in a Phase II/III clinical trial for the treatment of Amyloid A
Amyloidosis. Alzhemed™, for the treatment of Alzheimer's Disease, is in a Phase III clinical
trial and Cerebril™, for the prevention of Hemorrhagic Stroke caused by Cerebral Amyloid
Angiopathy has completed a Phase II clinical trial.
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 website at: (www.neurochem.com).
This news release contains forward-looking statements regarding the potential for Alzhemed™ and
further development efforts. These statements are based on the current expectations of management. Drug
development involves numerous risks and uncertainties, which could cause actual results to differ
materially from expectations. Promising results and successes in early stage clinical trials do not
ensure that later stage or larger scale clinical trials will be successful. For instance,
Alzhemed™ may not show the same benefits, results or safety profile in later stage or larger
scale clinical trials. Unexpected concerns may arise during clinical trials or in the course of
developing Alzhemed™ which would delay the start of later stage or larger scale clinical
trials. Additional risks and uncertainties include: 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. Neurochem does not undertake any
obligation to publicly update its forward-looking statements, whether as a result of new information,
future events, 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
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