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, 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.
April 19, 2005
By: /s/ David Skinner
-----------------------------------
David Skinner
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, PhD Tel: (450) 680-4572
Vice President, Corporate Communications lhebert@neurochem.com
NEUROCHEM ANNOUNCES PRELIMINARY RESULTS OF
PHASE II/III CLINICAL STUDY FOR FIBRILLEX(TM)
PLANS MEETING WITH FDA TO PRESENT RESULTS
Ecublens, Switzerland, April 18, 2005 - Neurochem (International) Limited
(Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX; TSX:
NRM), announced today preliminary results from the Phase II/III clinical study
for its investigational product candidate Fibrillex(TM) for the treatment of
Amyloid A (AA) Amyloidosis, a disease that normally progresses to end-stage
renal failure and death and for which no specific treatment exists.
This trial was the largest placebo-controlled study ever done in this patient
population and provides a new understanding about the course of the disease.
There were 183 patients enrolled in the Phase II/III clinical trial: 89 on
Fibrillex(TM) and 94 on placebo. Patients were treated for 24 months. The
objective of the study was to determine the ability of Fibrillex(TM) to treat AA
Amyloidosis and to assess safety compared with placebo in the patient population
with impaired renal function at baseline. The composite primary endpoint of the
study included kidney function measurements and death and called for a 20
percent absolute difference in the number of patients stabilized/improved
between the Fibrillex(TM) and placebo groups.
An assessment of the preliminary data on the composite primary endpoint
indicates that there were 13.4 percent more patients whose condition remained
stable or improved on Fibrillex(TM) compared to placebo (p-value of 0.06).
However, Fibrillex(TM) did not achieve the study's pre-specified p-value of 0.01
on the primary endpoint. Preliminary analysis of all parameters of the secondary
efficacy endpoints measuring the decline in renal function, including
progression to end-stage renal failure/dialysis and slope of
decline of creatinine clearance, suggests that Fibrillex has a clinical effect
on the course of AA Amyloidosis.
The preliminary data also suggest Fibrillex(TM) is well tolerated and the
overall incidence of adverse events, including serious adverse events, is not
significantly different between Fibrillex(TM)-treated and placebo-treated
patients.
Accordingly, Neurochem intends to continue with plans to seek regulatory
approval of Fibrillex(TM). As part of this process the company will pursue
discussions about its data with the U.S. Food and Drug Administration (FDA) in
line with established procedures for its on-going Pilot 2 Program. Neurochem and
its partner remain committed to the development of Fibrillex(TM).
NEXT STEPS
The company plans to complete its analysis of the Phase II/III data and present
it to the FDA as soon as possible. It also plans to present data at
international medical conferences in the first half of 2005. Neurochem intends
to honor its commitment to continue to supply Fibrillex(TM) to any patient
receiving the drug through the 24-month on-going open-label extension study.
Patients currently on Fibrillex(TM) should consult their physician about their
on-going treatment at the first opportunity.
ABOUT FIBRILLEX(TM)
Fibrillex(TM) is an oral investigational product candidate for the treatment of
AA Amyloidosis through the prevention of amyloid fibril formation.
Fibrillex(TM) 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.
Fibrillex(TM) has already received Orphan Drug Status designation in the United
States and Orphan Medicinal Product designation in Europe.
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, gastrointestinal bleeding,
abdominal pain and malabsorption. Enlargement of the liver and the spleen may
also occur in some patients.
ABOUT NEUROCHEM INC. Neurochem Inc. is focused on the development and
commercialization of innovative therapeutics for neurological disorders. Its
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
concluded in December 2004. 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.
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This news release contains forward-looking statements regarding Fibrillex(TM),
as well as 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. Additionally, 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.