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: October, 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):
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.
October 16, 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
FOR FURTHER INFORMATION, PLEASE CONTACT:
Lise Hebert, Ph.D. Tel: (450) 680-4570
Vice President, Corporate Communications lhebert@neurochem.com
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NEUROCHEM SUBMITS A COMPLETE RESPONSE TO FDA APPROVABLE
LETTER FOR KIACTA(TM)
ECUBLENS, SWITZERLAND, OCTOBER 16, 2006 -- Neurochem (International) Limited
(Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX; TSX:
NRM), announces today that it has submitted a complete response to the U.S. Food
and Drug Administration's (FDA) August 2006 approvable letter for KIACTA(TM).
The Company is seeking marketing approval of its investigational product
candidate KIACTA(TM) (eprodisate; formerly FIBRILLEX(TM)) for the treatment of
Amyloid A (AA) amyloidosis. Today, there is still no specific treatment for AA
amyloidosis, a deadly disease which often destroys kidney function.
The complete response includes the data on safety and efficacy from a follow-up
of all 183 patients who were enrolled in the Phase II/III clinical trial.
Following the suggestion of the FDA in its approvable letter, Neurochem
successfully retrieved the most recent health information (i.e. dialysis/end
stage renal disease (ESRD) or death from all causes, regardless of when the
clinical event occurred) for all 183 study subjects, including patients
currently enrolled in the open-label extension study and all patients who
discontinued their participation in the study. The median time of follow-up was
approximately 36 months.
The statistical methodology, as discussed with the FDA, includes the analysis
(log-rank test) to compare the time required to progress to dialysis/ESRD and to
progress to a composite endpoint of dialysis/ESRD or death (all causes) between
the two groups originally randomized to either KIACTA(TM) or placebo(1). The
results of the follow-up analysis included in the complete response are the
following:
o Fewer patients progressed to dialysis/ESRD in the KIACTA(TM) group
(18), versus in the placebo group (32). The Kaplan-Meier plot and
log-rank analysis(2) showed that it took longer for the KIACTA(TM)
group to progress to dialysis/ESRD than the placebo group (log-rank
test; p-value of 0.018).
o The follow-up analysis on the composite endpoint of dialysis/ESRD or
death was also in favor of the KIACTA(TM) group as fewer patients (32)
progressed to dialysis/ESRD or death versus the placebo group (44).
The Kaplan-Meier plot
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and log-rank analysis showed that it also took longer for the
KIACTA(TM) group to progress to dialysis/ESRD or death than the
placebo group (log-rank test; p-value of 0.062).
The follow-up analysis also showed that 56 patients progressed to
death from all causes: 25 patients were from the group originally
randomized to KIACTA(TM) and 31 patients were from the group
originally randomized to placebo.
o The updated safety information shows that KIACTA(TM) continues to be
safe and tolerated over long-term exposure in the two groups
(originally randomized to KIACTA(TM) or placebo).
"Taken together with the results already submitted in the original NDA, which
included the double-blind phase and one year of the extension phase of the
trial, the results from the follow-up analysis continue to provide evidence of
the benefit of KIACTA(TM) for the treatment of AA amyloidosis and KIACTA(TM)'s
favorable effect on slowing the progression of renal impairment," said Dr.
Francesco Bellini, Chairman, President and CEO of Neurochem Inc.
ABOUT THE REGULATORY APPLICATIONS
UNITED STATES
Neurochem previously filed a New Drug Application with the FDA for KIACTA(TM)
for the treatment of AA amyloidosis in February 2006 and received an approvable
letter in August 2006.
As previously reported, in its action letter (approvable letter), the FDA
requested additional efficacy information, as well as a safety update. The FDA
stated that this efficacy information would probably need to be addressed by one
or more additional clinical trials. As an alternative, the FDA also stated that
significant findings obtained from a complete follow-up of patients in the
existing study could be persuasive.(3)
EUROPE
In September 2006, Neurochem announced that its Marketing Authorization
Application (MAA) for KIACTA(TM) had been validated by the European Medicines
Agency, confirming that the regulatory review had started. The Company is
seeking marketing approval of KIACTA(TM) for the treatment of AA amyloidosis in
the European Union (EU).
The MAA for KIACTA(TM) will be reviewed under the Centralized Procedure, where
marketing authorization is applied for all EU Member States (numbering 25
countries today), plus Norway and Iceland.
Neurochem has an exclusive collaboration and distribution agreement for
KIACTA(TM) with Centocor, Inc. Distribution rights granted to Centocor are
worldwide, with the exception of Canada, Switzerland, China, Japan, Taiwan and
South Korea which remain with Neurochem. KIACTA(TM) is a trademark of
Centocor, Inc.
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ABOUT KIACTA(TM)
KIACTA(TM) was investigated in a landmark international, randomized,
double-blind, placebo-controlled, and parallel-designed clinical trial in which
183 AA amyloidosis patients were enrolled at 27 sites around the world. Patients
who completed the clinical trial were eligible for enrollment in an ongoing
open-label extension study, some of whom have now been receiving KIACTA(TM) for
more than five years.
KIACTA(TM) has received Orphan Drug Designation in the U.S. and has been
designated as an Orphan Medicinal Product in Europe, which normally provide
seven and ten years of market exclusivity, respectively, upon regulatory
approval.
ABOUT AMYLOID A (AA) AMYLOIDOSIS
A progressive and fatal condition, AA amyloidosis occurs in a proportion of
patients with chronic inflammatory disorders, chronic infections and inherited
diseases such as Familial Mediterranean Fever. The kidney is the organ most
frequently affected and progression to dialysis /ESRD is the most common
clinical manifestation in this disease. Currently, there is no approved therapy
to treat AA amyloidosis and about half of all patients diagnosed with the
disease die within five years of diagnosis.
ABOUT NEUROCHEM
Neurochem Inc. is focused on the development and commercialization of innovative
therapeutics to address critical unmet medical needs. Eprodisate (KIACTA(TM);
formerly FIBRILLEX(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.
(1) It is important to note that all patients who completed the Phase II/III
clinical trial were eligible to participate in the open-label extension study
and all received KIACTA(TM).
(2) The Kaplan-Meier method is a nonparametric technique for estimating
time-related events. It estimates the cumulative probability of individuals
remaining free of the endpoint at any time after baseline. It is especially
applicable when length of follow-up varies from patient to patient. The log-rank
test compares events occurring at all time points on the Kaplan-Meier curve.
(3) Source: Neurochem press release, August 11, 2006.
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This news release contains forward-looking statements regarding eprodisate
(KIACTA(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. There is no certainty that regulators will
ultimately approve eprodisate (KIACTA(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. Neither
Neurochem Inc., nor Neurochem (International) Limited undertake any obligation
to publicly update any forward-looking statements, whether as a result of new
information, future events, or otherwise. Please see Neurochem Inc.'s Annual
Information Form for further risk factors that might affect Neurochem Inc.,
Neurochem (International) Limited and their respective businesses.