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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: November, 2006
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):
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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.
November 6, 2006
By: /s/ David Skinner
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David Skinner, Vice President,
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) 680-4572
Vice President, Corporate Communications lhebert@neurochem.com
NEUROCHEM RECEIVES RECOMMENDATIONs FROM
DATA SAFETY MONITORING BOARDS TO CONTINUE
PHASE III CLINICAL TRIALS FOR TRAMIPROSATE (ALZHEMED(TM))
LAVAL, QUEBEC, NOVEMBER 6, 2006 -- Neurochem Inc. (NASDAQ: NRMX; TSX: NRM),
announces that it has received recommendations from both the North American and
European Data Safety Monitoring Boards (DSMB) to continue its two Phase III
clinical trials currently ongoing for tramiprosate (ALZHEMED(TM)), Neurochem's
investigational product candidate for the treatment of Alzheimer's disease (AD).
The two DSMBs are made up of independent clinical experts who monitor and
evaluate the safety of patients taking part in the tramiprosate (ALZHEMED(TM))
Phase III clinical trials. In North America, this fifth recommendation by the
DSMB was based on the recent review of the available safety data from 1,052
patients who have been on study medication for an average of 12.9 months. The
Company announced previous recommendations by the North American DSMB in
February 2006, and April, June and October 2005.
In Europe, this first recommendation by the DSMB members was based on their
recent review of the available safety data from 333 patients who have been on
study medication for an average of 1.8 months.
Tramiprosate (ALZHEMED(TM)) is a small, orally-administered molecule known as an
amyloid (BETA) antagonist, which crosses the blood-brain-barrier, binds to
soluble A(beta) peptide and interferes with the amyloid cascade that is
associated with amyloid deposition and the toxic effects of A(BETA) peptide in
the brain.
ABOUT THE PHASE III CLINICAL TRIALS FOR TRAMIPROSATE (ALZHEMED(TM))
Neurochem is currently conducting a multi-center, randomized, double-blind,
placebo-controlled and parallel-designed, 18-month Phase III clinical trial in
1,052 mild-to-moderate AD patients, which is being carried out at close to 70
clinical sites across the United States and Canada. The trial is scheduled to be
completed in January 2007. To date, 542 patients have completed 18 months on
study medication. All patients who complete the North American Phase III
clinical trial are eligible to receive tramiprosate (ALZHEMED(TM)) in an
open-label extension study.
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Neurochem is also actively advancing an 18-month Phase III clinical trial for
tramiprosate (ALZHEMED(TM)) in placeEurope, which was initiated in September
2005. The ongoing European Phase III clinical trial, an international,
multi-center, randomized, double-blind, placebo-controlled and parallel-designed
study, is progressing on schedule and is designed to investigate the safety,
efficacy and disease-modifying potential of tramiprosate (ALZHEMED(TM)). Some
930 mild-to-moderate AD patients are expected to take part and enrollment is
expected to be completed in fall 2006.
ABOUT ALZHEIMER'S DISEASE
Alzheimer's disease (AD), associated with specific brain pathologies, is a
progressive form, and the most common cause, of dementia. It impairs a person's
cognitive and motor functions, affects their ability to undertake basic daily
activities, alters their behavior and gradually destroys their brain.
Current treatments for AD provide benefit to patients through the alleviation of
symptoms; however, the underlying disease is not directly affected. Research is
now capitalizing on advanced knowledge about the biochemistry of A(BETA) and the
pathway by which it is produced. The goal is the development of
disease-modifying therapies with the capacity to slow or arrest the progression
of AD.
Almost five million individuals in the United States alone currently suffer from
the condition. The U.S. Alzheimer's Association estimates that by the year 2025,
over 22 million people worldwide will be afflicted.
ABOUT NEUROCHEM INC.
Neurochem Inc. is focused on the development and commercialization of innovative
therapeutics to address critical unmet medical needs. Eprodisate (KIACTA(TM)) is
currently being developed for the treatment of AA amyloidosis, and is under
regulatory review for marketing approval by the U.S. Food and Drug
Administration and European Medicines Agency. Tramiprosate (ALZHEMED(TM)), for
the treatment of Alzheimer's disease, is currently in Phase III clinical trials
in both North America and Europe and tramiprosate (CEREBRIL(TM)), 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.
This news release contains forward-looking statements regarding tramiprosate
(ALZHEMED(TM)) as well as regarding continuing and further development efforts.
These statements are based on the current analysis and expectations of
management. Drug development necessarily involves numerous risks and
uncertainties, which could cause actual results to differ materially from this
current analysis and these expectations. Analysis regarding the results of
clinical trials may not provide definitive results regarding safety,
tolerability or therapeutic benefits. Even if all the endpoints sought in the
clinical trials were met (which is not certain), there is no certainty that
regulators would ultimately approve tramiprosate (ALZHEMED(TM)) for sale to the
public. Risks and uncertainties may include: failure to demonstrate the safety,
tolerability and efficacy of our product, the expense and uncertainty of
obtaining regulatory approval, including from the FDA, and the possibility of
having to conduct additional clinical trials. Further, even if regulatory
approval is obtained, therapeutic products are generally subject to: stringent
on-going governmental regulation, challenges in gaining market acceptance, and
competition. Neurochem does not undertake any obligation to publicly update its
forward-looking statements, whether as a result of new information, future
events, or otherwise. Please see the Annual Information Form for further risk
factors that might affect the Company and its business.