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: February, 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.
February 13, 2006
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, Ph.D. Tel: 1-450-680-4570
Vice President, Corporate Communications Fax: 1-450-680-4501
lhebert@neurochem.com
---------------------
NEUROCHEM SUBMITS NDA FOR FIBRILLEX(TM)
ECUBLENS, SWITZERLAND, February 13, 2006 -- Neurochem (International) Limited
(Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX; TSX:
NRM), announces today that the Company has submitted to the U.S. Food and Drug
Administration (FDA) the final modules of its new drug application (NDA) for
eprodisate (Fibrillex(TM)). The Company is seeking marketing approval of its
investigational product candidate Fibrillex(TM) for the treatment of Amyloid A
(AA) amyloidosis. The submission announced today completes this "rolling" NDA
that was initiated last August, under the Continuous Marketing Application (CMA)
Pilot 1 program. The FDA agreed in June 2005 to file and review the NDA.
AA amyloidosis is a progressive and fatal condition that 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 by AA amyloidosis, and progression to dialysis and end
stage renal disease is the most common cause of death in this disease. New
approaches to treatment for AA amyloidosis are urgently needed due to lack of
specific therapies. Fibrillex has received Orphan Drug Designation status in the
United States as it is estimated that there are about 20,000 patients in North
America.
"Completion of this application to the FDA for Fibrillex(TM) marks a very
important milestone in Neurochem's progression towards its mission of bringing
novel and innovative drugs to market thereby addressing serious and unmet
medical needs," said Dr. Francesco Bellini, Chairman, President and Chief
Executive Officer. "We believe that the NDA package supports the clinically and
statistically meaningful effect of this product candidate on the preservation of
kidney function in this patient population and its benign safety profile," he
added.
"Effective treatment for AA amyloidosis is an important unmet medical need,"
said Laura M. Dember, M.D., Nephrologist and Associate Professor of Medicine at
Boston University School of Medicine. Dr. Dember was a principal investigator
for Neurochem's Phase II/III clinical trial. "Patients with this disease often
progress to end-stage renal failure, and many die. There
is currently no treatment directed specifically at AA amyloidosis. This drug has
the potential to provide a much needed therapeutic solution for this devastating
illness."
ABOUT THE PHASE II/III CLINICAL TRIAL
The Phase II/III clinical trial for Fibrillex(TM) was a two-year, international,
multi-center, randomized, double-blind, placebo-controlled, and
parallel-designed trial to evaluate the safety and efficacy of Fibrillex(TM) in
patients suffering from AA amyloidosis. Neurochem enrolled 183 patients for this
trial, which was conducted at 27 sites located across North America, Europe and
Israel.
Neurochem has an exclusive collaboration and distribution agreement for
Fibrillex(TM) with Centocor, Inc.
ABOUT NEUROCHEM
Neurochem is focused on the development and commercialization of innovative
therapeutics to address critical unmet medical needs. Eprodisate (Fibrillex(TM))
is designated as an orphan drug, is a Fast Track product candidate and is also
part of FDA Continuous Marketing Application Pilot 1 and Pilot 2 programs. The
Phase II/III clinical trial of Fibrillex(TM) for the treatment of AA amyloidosis
was concluded in April 2005. The Company has completed its submission of a New
Drug Application for Fibrillex(TM) that the FDA agreed in June 2005 to file and
review. 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 eprodisate
(Fibrillex(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 Fibrillex(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.