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: April, 2004
Commission File Number: 000-50393
NEUROCHEM INC.
7220 Frederick-Banting, Suite 100
Saint-Laurent, Quebec
H4S 2A1
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.
April 14, 2004
By: /s/ David Skinner
------------------------------------
David Skinner
Director, Legal Affairs,
General Counsel and Corporate Secretary
[NEUROCHEM LOGO] NEUROCHEM INC.
7220 Frederick-Banting, Suite 100
Saint-Laurent, Quebec H4S 2A1
NEUROCHEM ANNOUNCES ADDITIONAL POSITIVE RESULTS IN
ON-GOING PHASE II EXTENSION STUDY FOR ALZHEMED(TM)
Neurochem reports interim positive results in Alzheimer's patients after 16
months of treatment with Alzhemed(TM) at 8th International Montreal/Springfield
Symposium on Advances in Alzheimer Therapy
MONTREAL, APRIL 14, 2004 - Neurochem, Inc. (NASDAQ: NRMX, TSX: NRM) reported
today additional positive interim data on cognitive function in 18 patients with
mild(1)-to-moderate(2) Alzheimer's Disease (AD). The results relate to patients
who have completed both the three-month randomized Phase II clinical trial and
an additional 13 months of treatment in the open-label Phase II extension study
(OLPES) with the investigational product candidate, Alzhemed(TM). The data is
based on cognitive function as measured by the ADAS-cog(3) test.
Out of the 30 AD patients who had previously completed 12 months of treatment on
Alzhemed(TM), Neurochem is reporting on the 23 mild-to-moderate AD patients who
have received the product candidate for 16 months. The mild-to-moderate AD
patients (n=18)(4) showed an average ADAS-cog score of +2.33 points, as opposed
to +9.65 points on average in comparable historical controls(5) with AD
patients. The mild AD patients (n= 11) responded the best and showed a change
from baseline in their average ADAS-cog score of -0.09 points. This result
compares favorably with a score of +7.62 points on average in comparable
historical controls. Five patients discontinued the treatment but not for
reasons of drug related adverse events. The Company will report on the seven
other patients later once they complete 16-months of treatment with
Alzhemed(TM).
Overall 82% of the mild AD patients had stabilized or improved cognitive
function tests even after 16 months of treatment with Alzhemed(TM).
"Neurochem's product candidate, Alzhemed(TM) has the potential to modify the
progression of AD by acting directly on its core pathology, something which is
of critical importance in the treatment of this disease, and something we have
not seen before," said Dr. Serge Gauthier, Professor of Neurology and
Neurosurgery, Psychiatry, Medicine and Associate Member of Pharmacology and
Therapeutics at McGill University, former President of the Consortium of
Canadian Centres for
Clinical Cognitive Research (C5R) and co-President of the Symposium with Drs
Ezio Giacobini and Jean-Pierre Michel from Geneva. "Alzhemed(TM) represents what
we believe will become the new paradigm for AD treatment. Unlike current
therapies, which treat just the symptoms of the disease, Alzhemed(TM) seems to
address the underlying cause. If cleared by regulatory agencies, Alzhemed(TM)
could provide an important treatment to benefit millions of Alzheimer patients,"
Dr. Gauthier concluded.
The complete data on all the patients who participated in the Phase II clinical
trial and the OLPES for a period of up to 20 months will be presented by Dr.
Paul S. Aisen at the 9th International Conference on Alzheimer's Disease and
Related Disorders to be held in Philadelphia, Pennsylvania, USA, from July 17 to
July 22, 2004. Dr. Aisen is the principal investigator of the Phase III clinical
trial for Alzhemed(TM) in the United States, and is Professor of Neurology and
Medicine at Georgetown University Medical Center.
ABOUT ALZHEMED(TM)
Alzhemed(TM) 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(TM) 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(Beta) protein to reduce the amyloid-induced toxicity on neuronal and
brain inflammatory cells associated with amyloid build-up in AD.
ABOUT THE PHASE III CLINICAL TRIALS FOR ALZHEMED(TM)
Phase III clinical trials to evaluate the safety and efficacy of Alzhemed(TM) in
AD are expected to begin in the first half of 2004. In preparation for the
initiation of the trials, the manufacturing of the product candidate has been
successfully completed and the selection of the clinical research organization
has been finalized.
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 the 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 for the United States 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 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.
2
In a 2000 report, the Biotechnology Industry Organization estimated that AD is
becoming the most widespread and costly age-related disorder in the United
States; the total cost of the disease has been estimated at $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 Fast Track Product candidate,
is in a Phase II/III clinical trial for the treatment of Amyloid A Amyloidosis.
Alzhemed(TM) and Cerebril(TM) have completed a Phase II clinical trial for the
treatment of Alzheimer's Disease and for the prevention of Hemorrhagic Stroke
caused by Cerebral Amyloid Angiopathy respectively.
For additional information on Neurochem, please visit our website at:
(www.neurochem.com).
1 - Mini Mental State Exam (MMSE): 19-25
2 - Mini Mental State Exam (MMSE): 13-18
3 - Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog). The
ADAS-cog is a 70- point scale designed to measure, with the use of
questionnaires, the progression and the severity of cognitive decline as seen
in AD. The ADAS-cog scale quantifies the number of wrong answers.
Consequently, a high score on the scale indicates a more severe case of
cognitive decline. When analysing results, a negative score indicates the
improvement of cognitive function and a positive score the deterioration of
such function.
The ADAS-cog has been validated by the regulatory authorities as the gold
standard scale for the monitoring of cognitive function in AD patients. This
scale is a compulsory parameter of efficacy when submitting for market
approval of an AD drug to the authorities such as the Food and Drug
Administration.
4 - n: number of patients per group.
5 - Stern, R.G., et al. Am.J.Psychiatry 151:3, March 1994.
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.
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.
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FOR FURTHER INFORMATION, PLEASE CONTACT:
Lise Hebert, Ph.D.
Vice President, Corporate Communications
lhebert@neurochem.com
Tel: (514) 337-4646
Fax: (514) 684-7972
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