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: July, 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.
July 29, 2004
By: /s/David Skinner
--------------------------------
David Skinner
Director, Legal Affairs,
General Counsel and Corporate Secretary
NEUROCHEM INC.
275 Armand-Frappier Blvd.
[NEUROCHEM "LOGO"] Laval, Quebec, Canada H7V 4A7
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FOR FURTHER INFORMATION, PLEASE CONTACT:
Lise Hebert, Ph.D. Tel: (450) 680-4500
Vice President, Corporate Communications Mobile: (514) 924-7394
lhebert@neurochem.com
NEUROCHEM'S ON-GOING OPEN-LABEL PHASE II EXTENSION STUDY
FOR ALZHEMED(TM) SHOWS CONTINUED POSITIVE INTERIM RESULTS
IN ALZHEIMER'S DISEASE PATIENTS AFTER 20 MONTHS
CONFERENCE CALL AND LIVE WEBCAST ON JULY 19, AT 10:00 A.M.
PHILADELPHIA, PA, JULY 19, 2004 -- Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)
announced today that interim results of an on-going open-label Phase II
extension study of the effects of Alzhemed(TM) on cognitive function and global
measure of performance in patients with mild(1)-to-moderate(2) Alzheimer's
Disease (AD) were presented at the 9th International Conference on Alzheimer's
Disease and Related Disorders (ICAD) in Philadelphia. The study showed that
overall, approximately 70% of the mild AD patients had stabilized or improved
cognitive function tests even after 20 months of enrollment in the Alzhemed(TM)
open-label Phase II extension study.
Alzhemed(TM) is an investigational oral product candidate for mild-to-moderate
AD that has been specifically designed to modify the course of the disease
through its anti-amyloid activity. Phase III trials on the product candidate
were launched in 70 clinical centers in North America last month.
Paul Aisen, M.D., Professor of Neurology and Medicine and Director, Memory
Disorders Program at Georgetown University Medical Center in Washington, D.C.,
presented data from the on-going open-label Phase II extension study for
Alzhemed(TM). The data are based on the evaluation of cognitive and global
performance as measured by the ADAS-cog(3) and CDR-SB(4) tests, respectively.
COGNITIVE FUNCTION
The study followed 19 mild-to-moderate AD patients who received study medication
for 20 months. The mild-to-moderate AD patients (n = 19)(5) showed an average
ADAS-cog score of +6.2 points, as opposed to +11.9 points on average in
comparable historical controls(6) with AD. A subset of mild AD patients (n = 10)
responded best and showed a change from baseline in their average ADAS-cog score
of +2.4 points. This result compares favorably with a score of +8.6 points on
average in comparable historical controls.
Last April, the Company issued data on the first 18 patients who had completed
16 months. Neurochem is now reporting on all patients with mild-to-moderate AD
who received study medication for 16 months. The mild-to-moderate AD patients
(n = 26) showed an average ADAS-cog score of +5.3 points, as opposed to
+9.6 points on average in comparable historical controls with AD. A subset of
mild AD patients (n = 15) responded well and showed a change from baseline in
their average ADAS-cog score of +1.7 points. This result compares favorably with
an average score of +7.6 points in comparable historical controls. Overall, nine
out of the 15 mild AD patients were stabilized or improved at 16-months.
GLOBAL MEASURE OF PERFORMANCE
The average CDR-SB score in the mild-to-moderate AD patients after 20 months on
study medication showed +2.7 points on average. These results compare favorably
with the already reported(7) 12-month mean change in the CDR-SB score of
+2.2 points change in comparable mild-to-moderate AD patients.
SAFETY AND TOLERABILITY
Alzhemed(TM) continues to be safe and well tolerated after up to 20 months of
follow-up. Nausea and vomiting occurred primarily at the beginning of the
treatment and decreased over time. By 16 months, no nausea and vomiting were
reported. Overall, five patients withdrew prematurely from the beginning of the
Phase II clinical trial over the 20-month period due to adverse events: three
due to nausea and vomiting, one because of weakness and weight loss and
another for increased agitation and delusion.
"These results in Alzheimer's patients are promising because typically, patients
decline significantly over a prolonged period," said Dr. Aisen, who also is
principal investigator in the United States for the Phase III study on
Alzhemed(TM). "Alzhemed(TM) has the potential to modify the progression of AD
because it acts directly on its core pathology. Because existing therapies can
only treat disease symptoms, Alzhemed(TM) could become the new paradigm for AD
treatment if it is approved by regulatory authorities."
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"Given the very long treatment period with Alzhemed(TM) in our on-going
open-label Phase II extension study, and even though the study was not designed
to be statistically significant, we are encouraged by the persisting
stabilization of the majority of mild AD patients receiving this product
candidate. This interim data strengthens our belief that Alzhemed(TM) is a
potential breakthrough to stop the cause of this devastating disease," said
Francesco Bellini, Ph. D., Chairman and CEO of Neurochem.
Neurochem's Phase III clinical trial on Alzhemed(TM) in North America will run
for a period of 18 months and be conducted in 50 U.S. and 20 Canadian clinical
centers. The Company anticipates launching its Phase III trial in Europe early
in 2005.
The 9th International Conference on Alzheimer's Disease and Related Disorders,
sponsored by the Alzheimer's Association, is the largest gathering in history of
Alzheimer's Disease researchers. More than 4,500 scientists from around the
world are present at the conference.
LIVE WEB CONFERENCE
Neurochem will hold a conference call on Monday, July 19, 2004, at 10:00 A.M.,
EDT, to discuss the latest interim clinical results of the Phase II open-label
extension study on Alzhemed(TM). The conference call will be webcast
simultaneously.
During the call, Dr. Francesco Bellini, Chairman and Chief Executive Officer of
Neurochem, and Dr. Denis Garceau, Neurochem's Vice President, Drug Development,
will summarize and comment on the new clinical results. Francine Gervais, Ph.D.,
Neurochem's Vice President, Research and Development, will also be available
following the presentations for questions from callers.
To participate in the conference call and webcast, please dial 1 877-888-4210
approximately 10 minutes prior to the start of the call AND access Neurochem's
website at www.neurochem.com. The dial-in number will allow participants to
listen and ask questions, while the webcast will provide a visual presentation.
A replay of the web cast will be available on Neurochem's website at 12:00 P.M.,
EDT. This webcast will include the conference call and the visual presentation.
For those wanting to access the audio portion only of the conference call, a
replay will be available from 12:00 P.M. EDT. Interested parties can dial
1-866 816-8948 or 416 695-9675, access code: 8490#. The replay will be available
for 72 hours.
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 many levels: in binding to soluble amyloid
beta (A(beta)) protein, to prevent and stop the formation and the deposition of
amyloid fibrils in the brain, and
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to reduce the amyloid-induced toxicity on neuronal and brain inflammatory cells
associated with amyloid build-up in AD.
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; the 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 also part of a Continuous Marketing Applications Pilot 2 program
and is currently in a Phase II/III clinical trial for the treatment of AA
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.
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(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
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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) -- Clinical Dementia Rating - sum of boxes rating scale (CDR-SB), a
measure of global performance.
(5) -- n: number of patients per group.
(6) -- Stern, R.G., et al. Am.J.Psychiatry 151:3, March 1994.
(7) -- Aisen, P.S., et al. JAMA 289: 2819, June 4, 2003.
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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