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, 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.
July 5, 2005
By: /S/ DAVID SKINNER
-----------------------------------
David Skinner
General Counsel and Corporate Secretary
NEUROCHEM INC.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
[NEUROCHEM "LOGO"]
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For further information, please contact:
Lise Hebert, PhD Tel: (450) 680-4571
Vice President, Corporate Communications Fax: (450) 680-4501
lhebert@neurochem.com
NEUROCHEM COMPLETES PATIENT RECRUITMENT FOR NORTH AMERICAN
PHASE III CLINICAL TRIAL FOR ALZHEMED(TM)
MILESTONE ON SCHEDULE
LAVAL, CANADA, JULY 5, 2005 -- Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) announced
today the completion of recruitment of the 950 patients with mild-to-moderate
Alzheimer's Disease (AD) for its North American Phase III clinical trial for
Alzhemed(TM), the Company's investigational product candidate for the treatment
of AD. The trial is being conducted in 51 U.S. and 17 Canadian clinical centers
across North America. The Company has completed the selection of sites for a
similarly sized Phase III clinical trial in Europe and expects to begin patient
recruitment in the fall of 2005.
"Completion of patient recruitment for the Phase III Alzhemed(TM) clinical trial
in North America is a major milestone for the Company," said Francesco Bellini,
Chairman, President and CEO of Neurochem. "To have recruited this large number
of patients in less than one year is an indication of the priority we have
placed upon developing this product candidate as well as the interest that
Alzhemed(TM) has raised to-date among researchers and physicians. We believe
Alzhemed(TM) may be able to provide patients with real hope."
The multi-center, randomized, double-blind, placebo-controlled and parallel
designed North American Phase III clinical trial is investigating the safety and
efficacy of Alzhemed(TM) for the treatment of AD in mild-to-moderate patients.
The patients have been randomized to receive either placebo or one of two
different dose levels of Alzhemed(TM) (100mg or 150mg twice daily) for a period
of 18 months. All participants must be treated with conventional AD therapies
and must be on stable dose for at least four months prior to the screening
visit. The two primary efficacy parameters are the change from baseline to month
18 in the ADAS-cog and CDR-SB scores(1). The potential disease modification
effect of Alzhemed(TM) is also assessed by brain volume change from baseline as
measured by Magnetic Resonance Imaging.
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 Aa protein
to reduce the amyloid-induced toxicity on neuronal and brain inflammatory cells
associated with amyloid build-up in AD.
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,
all of which make 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 is approximately 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. The
Company is in the process of submitting a New Drug Application (NDA) for
Fibrillex(TM) that the FDA has agreed to file and review.
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.
1. Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog);
Clinical Deterioration Scale Sum of Boxes (CDR-SB))
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 Inc.'s control. The 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 Inc. 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 Inc. Consequently, actual future results may differ
materially from the anticipated results expressed in the forward-looking
statements. The reader should not place undue reliance on, if any, the
forward-looking statements included in this news release. These statements speak
only as of the date made and Neurochem Inc. 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.