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: December, 2004
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.
December 7, 2004
By: /s/ David Skinner
---------------------------------------
David Skinner
Director, Legal Affairs,
General Counsel and Corporate Secretary
[NEUROCHEM LOGO] NEUROCHEM INC.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
FOR FURTHER INFORMATION, PLEASE CONTACT:
Lise Hebert, Ph.D. Tel: (450) 680-4572
Vice President, Corporate Communications Fax: (450) 680-4501
lhebert@neurochem.com
NEUROCHEM ANNOUNCES COMPLETION OF
PHASE II/III CLINICAL TRIAL FOR FIBRILLEX(TM)
MONTREAL, DECEMBER 7, 2004 - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) announced
today the completion of the treatment phase of the double-blind,
placebo-controlled, randomized and international Phase II/III clinical trial
(Study CL-503004), to measure the efficacy and safety of 1,3-propanedisulfonate
(1,3PDS; Fibrillex(TM)) for the treatment of Amyloid A (AA) Amyloidosis, a fatal
consequence of chronic inflammatory and infectious diseases. Neurochem is the
first biopharmaceutical company to complete a large clinical trial for this
disease for which no specific treatment is approved. The Company expects to
issue the quality-controlled trial data during the second quarter of 2005.
The final study visits by the last patients enrolled in the trial were recently
completed. All patients who completed the trial have been invited to join the
two-year open-label Phase II/III extension study (OLPES).
"Our timely completion of this clinical trial, which we call the Fibrillex(TM)
Amyloidosis Secondary Trial, or FAST, is a major milestone for the development
of this product candidate," said Denis Garceau, PhD, Vice President, Drug
Development. "We expect to announce the trial results during the second quarter
of 2005. We are at the same time in on-going discussions with the FDA as part of
its Pilot 2 program."
ABOUT THE "FAST" TRIAL FOR FIBRILLEX(TM)
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 efficacy and safety of the
investigational product candidate in patients suffering from AA Amyloidosis
confirmed by biopsy and renal involvement. Neurochem successfully completed the
enrollment of 183 patients for the Phase II/III trial, which was conducted at 27
sites located across North America, Europe, North Africa and Israel. The most
frequent underlying diseases in patients during the trial were rheumatoid
arthritis and Familial Mediterranean Fever (49% and 19%, respectively)(1). The
mean time from onset of underlying disease until AA Amyloidosis was 14.6 +/-
10.6 years and nephrotic syndrome was present in 32% of the participating
patients.
ABOUT FIBRILLEX(TM)
Fibrillex(TM) is an oral product candidate for the treatment of AA Amyloidosis
through the prevention of amyloid fibril formation. Fibrillex(TM) belongs to the
class of glycosaminoglycan (GAG) mimetics, better known as amyloid
disease-modifiers. By mimicking GAGS,
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Fibrillex(TM) prevents the AA fibril formation and the deposition of AA fibrils
in organs, which, when left untreated, leads to organ failure.
Fibrillex(TM) has been selected by the Cardio-Renal Drug Product Division of the
US Food and Drug Administration (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.
FibrillexTM has already received Orphan Drug Status designation in the United
States and Orphan Medicinal Product designation in Europe, which normally
provide a drug seven and ten years of market exclusivity, respectively, upon
regulatory approval.
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 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, abdominal pain and malabsorption.
Enlargement of the liver and the spleen may also occur in some patients.
Patients suffering from this disease have a poor prognosis, with a five-year
survival rate of approximately 50%.(2) Left untreated, patients gradually
progress to end-stage renal failure, which is the cause of death in at least 35%
of the cases.(3), (4)
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.
1,3PDS; Fibrillex(TM) designated as an orphan drug and a Fast Track Product
candidate, while having completed a Phase II/III clinical trial for the
treatment of AA Amyloidosis with data expected to be released in the second
quarter of 2005, is also part of an FDA Continuous Marketing Applications Pilot
2 program. 3-amino-1-propanesulfonic acid (3APS; Alzhemed(TM)), for the
treatment of Alzheimer's Disease, is in a Phase III clinical trial and
Cerebril(TM), for the prevention of Hemorrhagic Stroke caused by Cerebral
Amyloid Angiopathy, has completed a Phase II 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
website at: www.neurochem.com.
(1) As recently presented at the American Society of Nephrology's Renal
Week 2004 Conference.
(2) Pepys, M., et al. Amyloidosis. Oxford Textbook of Medicine (4th ed.)
Oxford: Oxford University Press 2003; 162-73.
(3) Gertz, M.A., et al. Medicine (Baltimore) 1991 Jul: 70(4); 246-56.
(4) Joss, N., et al. QJMed. 2000: 93; 535-42.
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This news release contains forward-looking statements regarding the potential
for Fibrillex(TM) and further development efforts. These statements are based on
the current expectations of management. Drug development involves numerous risks
and uncertainties, which could cause actual results to differ materially from
expectations. Promising results and successes in early stage clinical trials do
not ensure that later stage or larger scale clinical trials will be successful.
Additional risks and uncertainties include: 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 or otherwise. Neurochem does not undertake any
obligation to publicly update its forward-looking statements, whether as a
result of new information, future events, or otherwise.