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 6, 2005
By: /s/ David Skinner
---------------------------------------
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
Vice President, Corporate Communications
Tel: (450) 680-4572
lhebert@neurochem.com
NEW FIBRILLEX(TM) DATA PRESENTED AT THE EUROPEAN RENAL
ASSOCIATION-EUROPEAN DIALYSIS AND
TRANSPLANT ASSOCIATION MEETING
ISTANBUL (TURKEY), JUNE 5, 2005 - Further analyses of the results of Neurochem's
Phase II/III clinical study for Fibrillex(TM), an investigational product
candidate for the treatment of Amyloid A (AA) Amyloidosis, were presented today
at the European Renal Association-European Dialysis and Transplant Association
(ERA-EDTA) meeting by Helen Lachmann, M.D., Senior Lecturer and Honorary
Consultant Nephrologist and co-investigator of the Phase II/III clinical trial,
National Amyloidosis Centre, Royal Free and University College Medical School,
Royal Free Hospital, London, UK. AA Amyloidosis is a rare disease that
frequently progresses to end-stage renal failure and death and for which no
specific treatment is approved for use.
The most recent analysis of the primary endpoint using the pre-specified Cox
proportional hazards regression model takes into account both the number of
events and the time to reach such an event. This analysis indicates that
Fibrillex(TM) reduces the risk of renal decline or all-cause mortality by 42%
(p-value of 0.025, 95% CI 0.366 - 0.934).
"While Fibrillex(TM) did not achieve the study's pre-specified p-value of 0.01
on the primary endpoint, the analysis of the data suggest useful clinical
effects of Fibrillex(TM)," said Dr. Lachmann. "This result supports the notion
that Fibrillex(TM) may preserve kidney function in patients who face this very
serious illness with no specific treatment to turn to" she added.
The Phase II/III trial enrolled 183 patients (89 on Fibrillex(TM), 94 on
placebo) in 13 countries, and was a randomized, double-blind,
placebo-controlled, and parallel-design study.
The primary analysis of the primary endpoint using the pre-specified
Cochran-Mantel-Haenszel means row score test compares the number of events at
the end of the study between the two treatment groups and was announced on April
18, 2005. This analysis showed there were 13.4% fewer patients who worsened in
the Fibrillex(TM) group as compared to placebo (p-value of 0.063, adjusted for
renal status at baseline).
SECONDARY ENDPOINTS
Analysis of secondary efficacy endpoints in Neurochem's trial, including
progression to end-stage renal disease/dialysis and slope of decline of
creatinine clearance, point in favor of Fibrillex(TM) reducing the risk of renal
decline events in AA Amyloidosis patients.
Patients in the trial receiving Fibrillex(TM) experienced a slower decline in
the mean slope of creatinine clearance of 4.7 ml/min/1.73 m2/year as compared to
placebo (p-value of 0.025). This effect was corroborated by the analysis of
another secondary endpoint being the slope of the reciprocal of serum
creatinine.
During the course of the study, Fibrillex(TM) delayed by 3.6 months the time
required to double serum creatinine (p-value of 0.081), delayed by 4.4 months
the time to reach a 50% decrease in creatinine clearance (p-value of 0.029) and
delayed by 5.3 months the time to progress to dialysis (p-value of 0.18), all as
compared to placebo.
There was no statistically significant difference in the median time between the
two groups to reach a 50% increase in creatinine clearance, time to death or
median change in proteinuria.
SAFETY DATA
The data suggest Fibrillex(TM) is well tolerated. The most frequent adverse
events experienced by the patients in this study were of gastrointestinal origin
and infections. The incidence of treatment-emergent adverse events (all
causalities) in patients on Fibrillex(TM) was comparable to placebo.
Additional data on the Phase II/III clinical trial will be presented at the
European League Against Rheumatism (EULAR) conference, Vienna, Austria, on June
9, 2005.
ABOUT FIBRILLEX(TM)
Fibrillex(TM) is an oral investigational product candidate for the treatment of
AA Amyloidosis through the prevention of amyloid fibril formation. It has
received Orphan Drug Status designation in the United States and Orphan
Medicinal Product designation in Europe.
Fibrillex(TM) also has been accorded "Fast Track Product" designation by the FDA
and has been selected by the Cardio-Renal Drug Product Division of the FDA to be
part of the Continuous Marketing Applications Pilot 2 program aimed at further
accelerating the development and eventual marketing of this product candidate.
Under this Pilot 2 program, each FDA division is permitted to select only one
product candidate.
ABOUT AA AMYLOIDOSIS
AA Amyloidosis is a progressive and fatal condition that occurs in a proportion
of patients with chronic inflammatory diseases, including rheumatoid arthritis,
ankylosing spondylitis, juvenile rheumatoid arthritis, and Crohn's disease. The
disease also occurs in
2
patients suffering from many other conditions ranging from chronic infections to
inherited inflammatory diseases such as Familial Mediterranean Fever. The most
common clinical presentation of AA Amyloidosis is renal dysfunction. Involvement
of the gastrointestinal system is also frequent and is usually manifested as
chronic diarrhea, gastrointestinal bleeding, abdominal pain and malabsorption.
Enlargement of the liver and the spleen may also occur in some patients.
End-stage renal failure is the main cause of death in 40-60% of cases. The
median survival time from diagnosis varies from 2 to 10 years depending on the
stage of the disease at the time of diagnosis.
No specific treatment is currently available for this orphan disease. The goal
of the existing therapies is limited to the control of the underlying chronic
inflammatory disease. The current therapeutic approaches are normally
non-specific, and may be toxic, invasive or ineffective.
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.
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.
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. Further, a delay in the process could be caused by a number of
factors, including a delay in Neurochem receiving the data; more time needed
than expected to achieve the appropriate degree of analysis; or more time needed
to ensure quality control and that the statistical analysis complies with
applicable regulations. 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.
3