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, 2005
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 13, 2005
By: /S/ DAVID SKINNER
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David Skinner
General Counsel and Corporate Secretary
NEUROCHEM INC.
275 Armand-Frappier Blvd.
[NEUROCHEM(Logo)] Laval, Quebec, Canada H7V 4A7
________________________________________________________________________________
For further information, please contact:
Lise Hebert, PhD Tel: (450) 680-4570
Vice President, Corporate Communications lhebert@neurochem.com
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NEUROCHEM RECEIVES SECOND POSITIVE RECOMMENDATION FROM
INDEPENDENT SAFETY REVIEW BOARD TO CONTINUE
PHASE III CLINICAL TRIAL FOR ALZHEMED(TM)
LAVAL, CANADA, JUNE 13, 2005 -- Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)
announced today that its Independent Safety Review Board (ISRB) has issued a
second recommendation to continue the Company's North American Phase III
clinical trial for Alzhemed(TM), an investigational product candidate for the
treatment of Alzheimer's Disease (AD).
"This additional positive recommendation by the Independent Safety Review Board,
reinforces our previous findings on the safety and tolerability of
Alzhemed(TM)," said Denis Garceau, PhD, Senior Vice President, Drug Development.
"Over 900 patients have been enrolled and the trial is on track for completion
as planned."
Neurochem's ISRB for Alzhemed(TM) is made up of independent medical experts who
monitor and evaluate the safety of patients taking part in the Alzhemed(TM)
Phase III clinical trial in North America. The recommendation by the ISRB
members was based on their recent review of the safety data from 742 patients
who have been treated with the medication for an average of 12 weeks. After
reviewing the safety information, the ISRB concluded that the trial should
continue as planned.
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: by preventing and stopping the
formation and the deposition of amyloid fibrils in the brain and by binding to
soluble Aa protein to reduce the amyloid-induced toxicity on neuronal and brain
inflammatory cells associated with amyloid build-up in AD.
Alzhemed(TM) has entered into a multicenter, randomized, double-blind,
placebo-controlled, three-armed, parallel-design Phase III clinical trial; 68
clinical centers have been enrolled in North America. The study will include
some 950 patients who will receive study medication over a period of 18 months.
The Company anticipates launching its Phase III trial in Europe in fall 2005.
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
neuronal 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 day-to-day activities.
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. 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.
In a 2000 report, the Biotechnology Industry Organization estimated that in the
United States the total cost of AD 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.
1,3-propanedisulfonate (1,3PDS; Fibrillex(TM)) is designated as an orphan drug
and a Fast Track Product candidate and is also part of an FDA Continuous
Marketing Applications Pilot 2 program. The Phase II/III clinical trial of
Fibrillex(TM) for the treatment of AA Amyloidosis was recently concluded and
preliminary results were issued in April and June 2005.
3-amino-1-propanesulfonic acid (3APS; Alzhemed(TM)), for the treatment of
Alzheimer's Disease, is in a Phase III clinical trial and 3APS (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.
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Certain statements contained in this news release, other than statements of fact
that are independently verifiable at the date hereof, may constitute
forward-looking statements. Such statements, based as they are on the current
expectations of management, inherently involve numerous risks and uncertainties,
known and unknown, many of which are beyond Neurochem's control. Such risks
include but are not limited to: 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, as well as other risks disclosed in public filings of
Neurochem. Consequently, actual future results may differ materially from the
anticipated results expressed in the forward-looking statements. The reader
should not place undue reliance, if any, on the forward-looking statements
included in this news release. These statements speak only as of the date made
and Neurochem is under no obligation and disavows any intention to update or
revise such statements as a result of any event, circumstances or otherwise.
Please see the Annual Information Form for further risk factors that might
affect the Company and its business.