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: April, 2004
Commission File Number: 000-50393
NEUROCHEM INC.
7220 Frederick-Banting, Suite 100
Saint-Laurent, Quebec
H4S 2A1
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.
April 26, 2004
By: /s/ David Skinner
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David Skinner
Director, Legal Affairs,
General Counsel and Corporate Secretary
NEUROCHEM INC.
7220 Frederick-Banting, Suite 100
[LOGO (NEUROCHEM)] Saint-Laurent, Qc H4S 2A1 Canada
________________________________________________________________________________
NEUROCHEM RECEIVES FOURTH CONSECUTIVE POSITIVE
RECOMMENDATION FROM DATA SAFETY MONITORING BOARD TO
CONTINUE PHASE II/III CLINICAL TRIAL FOR FIBRILLEX(TM)
MONTREAL, CANADA, APRIL 26, 2004 - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)
announced today that its independent Data Safety Monitoring Board (DSMB) has
issued a fourth unanimous recommendation to continue the Company's Phase II/III
clinical trial with the orphan-product candidate Fibrillex(TM) for the treatment
of Amyloid A (AA) Amyloidosis. This disorder is a serious consequence of chronic
infectious and inflammatory diseases, including Rheumatoid Arthritis (RA). No
specific treatment currently exists for AA Amyloidosis and patients who suffer
from it have a five-year survival rate of approximately 50%. Neurochem expects
to complete the clinical trial by January 2005.
"This fourth unanimous recommendation by our Data Safety Monitoring Board
coupled with orphan drug status in the U.S. and Europe and the Fast Track
Product designation which we recently received from the U.S. Food and Drug
Administration for this product candidate, indicate how serious an unmet medical
need AA Amyloidosis is," stated Denis Garceau, Ph.D., Vice President of Drug
Development at Neurochem. "People who suffer from uncontrolled chronic
inflammation and who do not respond well to their therapy, are at high risk of
developing this disease. I am, therefore, pleased that our development program
is on schedule, and that, assuming successful completion of the trial and
regulatory approvals, we will be able to launch this product by the end of
2005."
Neurochem's Data Safety Monitoring Board is made up of independent medical
experts who monitor and evaluate the safety of patients taking part in the
Fibrillex(TM) clinical trial. The recommendation by the DSMB members was based
on their recent review of the safety data from 183 patients of whom 144 have
completed at least twelve months of the Phase II/III clinical study.
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ABOUT FIBRILLEX(TM)
The Phase II/III clinical trial for Fibrillex is a two-year, international,
multicenter, 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 has successfully completed the enrollment of 183
patients for this Phase II/III trial, which is being conducted at 27 sites
located across North America, Europe and Israel. This trial is planned to end in
January 2005. After two years of treatment patients are invited to participate
in a two-year open-label study with Fibrillex(TM). Fibrillex(TM) has received
orphan drug designation in the United States and Europe, which normally entails
market exclusivity on this product candidate for seven years and ten years
respectively, once it is approved. It has also received Fast Track Product
designation by the U.S. Food and Drug Administration (FDA) which will make it
eligible for priority reviews by the FDA.
Fibrillex(TM) is an oral product candidate for the treatment of AA Amyloidosis
through the prevention of amyloid fibril formation. FibrillexTM belongs to the
class of glycosaminoglycan (GAG) mimetics which has anti-amyloid properties
following its binding to the AA protein and is expected to prevent AA fibril
formation and the deposition of AA fibrils in organs.
ABOUT AA AMYLOIDOSIS
AA Amyloidosis is a progressive and fatal condition that occurs in a proportion
of patients with chronic inflammatory diseases, including RA, ankylosing
spondylitis, juvenile rheumatoid arthritis, and Crohn's disease. The disease
also occurs in 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
kidney malfunction such as proteuneria. The gastrointestinal system is also
frequently involved, with patients experiencing chronic diarrhea,
gastrointestinal bleeding, abdominal pain and malabsorption. Enlargement of the
liver and the spleen may also occur in some patients. Patients suffering from AA
Amyloidosis have a poor prognosis with five- to 15-year survival rates of 50%
and 25%, respectively. End-stage renal failure is the cause of death in 40% to
60% of cases. There is currently no specific therapy for the treatment of AA
Amyloidosis.
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.
Fibrillex(TM), designated an orphan drug and a Fast Track Product candidate, is
in a Phase II/III clinical trial for AA amyloidosis. Alzhemed(TM) and
Cerebril(TM) have completed a Phase II clinical trial for Alzheimer's Disease
and for the prevention of Hemorrhagic Stroke caused by Cerebral Amyloid
Angiopathy, respectively. For additional information on Neurochem, please visit
our website at: www.neurochem.com.
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All of the statements contained in this news release, other than statements of
fact that are independently verifiable at the date hereof, are forward-looking
statements. Such statements, based as they are on the current expectations of
management, inherently involve numerous risks and uncertainties, known and
unknown. Some examples of known risks are: the impact of general economic
conditions, general conditions in the pharmaceutical industry, changes in the
regulatory environment in the jurisdictions in which Neurochem does
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business, stock market volatility, fluctuations in costs, and changes to the
competitive environment due to consolidation or otherwise. Consequently, actual
future results may differ materially from the anticipated results expressed in
the forward-looking statements.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Lise Hebert, Ph.D.
Vice President, Corporate Communications
lhebert@neurochem.com
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Tel: (514) 337-4646
Fax: (514) 337-5339