UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT
TO RULE 13A-16 OR 15D-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of: June, 2004
Commission File Number: 000-50393
NEUROCHEM INC.
275 Armand-Frappier Boulevard
Laval, Quebec
H7V 4A7
Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40 F. Form 20-F [ ] Form 40-F [X]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
Yes [ ] No [X]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7):
Yes [ ] No [X]
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g-3 under the Securities Exchange Act of 1934.
Yes [ ] No [X]
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
SIGNATURES:
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
NEUROCHEM INC.
June 21, 2004
By: /s/ David Skinner
---------------------------------------
David Skinner
Director, Legal Affairs,
General Counsel and Corporate Secretary
NEUROCHEM INC.
275 Armand-Frappier Blvd.
[NEUROCHEM - (LPGO)] Laval, Quebec, Canada H7V 4A7
________________________________________________________________________________
NEUROCHEM ANNOUNCES THE LAUNCH OF NORTH AMERICAN
PHASE III CLINICAL TRIAL ON ALZHEMEDTM
FOR THE TREATMENT OF ALZHEIMER'S DISEASE
MONTREAL, JUNE 21, 2004 - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) announced
today that it has launched its North American Phase III clinical trial on
Alzhemed(TM), following an investigators' meeting attended by more than 200
clinicians and clinical monitors held in Montreal from June 18 to June 20, 2004.
AlzhemedTM 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(TM) 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(TM) for a period of 18
months. The Company anticipates launching its Alzhemed(TM) European Phase III
clinical trial early in 2005.
"We are on schedule for the launch of our Phase III clinical trial program on
AlzhemedTM," 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(TM)
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(TM) is an orally administered, small organic molecule that has been
specifically designed to modify the course of AD by binding to amyloid a (Aa)
protein and keeping it in a non-fibrillar form. As part of a "disease modifying"
class of product candidates, Alzhemed(TM) 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, AlzhemedTM 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(TM) is well tolerated in individuals with AD.
Furthermore, the majority of patients receiving Alzhemed(TM) 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(TM) and that the
investigational product candidate was well tolerated in individuals with
mild-to-moderate AD. Furthermore, Alzhemed(TM) 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(TM) 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(TM) could offer new hope for the thousands of
people afflicted with Alzheimer's disease", said Dr. Serge Gauthier,
Alzhemed(TM) 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(TM) 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(TM), 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(TM), for the treatment of Alzheimer's Disease, is in a
Phase
III clinical trial and Cerebril(TM), 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(TM) 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(TM) 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(TM) 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:
Lise Hebert, Ph.D. Felicia Amilcar
Vice President, Corporate Communications Manager, Investor Relations
lhebert@neurochem.com familcar@neurochem.com
Tel: (450) 680-4500 Tel: (450) 680-4572
Fax: (450) 680-4501 Fax: (450) 680-4501