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 27, 2004
By: /s/ David Skinner
---------------------------------------
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 ANNOUNCES PROMISING PHASE II RESULTS FOR CEREBRIL(TM)
AT THE AMERICAN ACADEMY OF NEUROLOGY'S 56TH ANNUAL MEETING
-- DATA SUPPORTS FURTHER CLINICAL DEVELOPMENT --
SAN FRANCISCO, CALIF., APRIL 27, 2004 - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)
will announce today, at the American Academy of Neurology's 56th Annual Meeting,
promising results from its Phase II clinical trial for Cerebril(TM), the
Company's investigational product candidate for the treatment of Hemorrhagic
Stroke due to Cerebral Amyloid Angiopathy (HS-CAA). The results will be
presented by Steven M. Greenberg, MD, Ph.D., Associate Professor of Neurology at
Harvard Medical School, Co-Director of the Neurology Clinical Trials Unit at the
Massachusetts General Hospital (MGH), and principal investigator of the
Cerebril(TM) Phase II clinical trial. There were no safety findings of concern
in patients treated with Cerebril(TM). The pharmacokinetic profile of
Cerebril(TM) has been well characterized and it was detected in the
cerebrospinal fluid (CSF) of the patients, suggesting its ability to cross the
blood-brain-barrier.
"These data support a good safety profile for Cerebril(TM) and provide a good
basis for advancing clinical development," said Dr. Greenberg. "Developing a
successful treatment for prevention of HS-CAA would be a major advance for the
stroke field, where HS-CAA remains arguably the only common form of stroke
without effective therapy."
"Demonstrating that Cerebril(TM) is safe in this patient population was a
critical factor in our drug development strategy for Cerebril(TM)," said Denis
Garceau, Ph.D., Vice President of Drug Development at Neurochem. "We are pleased
to have met our primary objectives of the Phase II study as we have identified
safe and well tolerated doses for our upcoming trial to investigate the efficacy
of this product candidate. Cerebril(TM) represents a potential new avenue for
the treatment of CAA, a major cause of Hemorrhagic Stroke. Based on these data,
we intend to initiate a Phase IIb clinical trial in early 2005 designed to test
Cerebril(TM) for the prevention of recurrence of stroke in patients suffering
from CAA."
ABOUT THE STUDY
The U.S. Phase II clinical trial evaluated the safety, tolerability, and
pharmacokinetic profile of Cerebril(TM) in HS-CAA patients who experienced lobar
cerebral hemorrhage.
The trial was a multicenter, randomized, double-blind and parallel-designed
study, conducted in five centers in the United States. Twenty-four CAA patients
with lobar cerebral hemorrhage were randomized to receive 3 different daily
doses of Cerebril(TM) (100, 200 and 300 mg) for a period of twelve weeks. The
data showed no safety findings of concern based on patient's clinical laboratory
tests, vital signs and electrocardiograms during follow-up physical exams. The
most frequent adverse events, namely nausea and vomiting, were mild-
-2-
to-moderate at all doses tested, and transient in the patients receiving 100mg
or 200mg daily of Cerebril(TM). Five patients withdrew prematurely: three
because of nausea and vomiting and two because of expected complications of CAA.
In January 2003, Dr. Greenberg was awarded a grant of approximately U.S.$1
million from the National Institutes of Health in support of Neurochem's Phase
II clinical trials of Cerebril(TM).
ABOUT CEREBRIL(TM)
Cerebril(TM) is a synthetic small organic molecule that has been specifically
designed to modify the course of HS-CAA. By binding with the amyloid B (AB)
protein, Cerebril(TM) is thought to prevent the amyloid fibrils from forming and
depositing in the small and intermediate blood vessels of the brain of patients
with CAA.
ABOUT HS-CAA
HS-CAA is characterized by the progressive invasion of the blood vessel walls in
the brain by amyloid fibrils. The blood vessels become brittle which can lead to
recurrent strokes and potentially devastating lobar hemorrhages in the brain. It
is considered a major form of stroke, for which there is currently no effective
treatment. While up to 80 percent of lobar hemorrhages are not fatal the first
time they occur, they are frequently recurrent and carry very high morbidity and
mortality rates.
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 as an orphan drug and as a Fast Track Product
candidate, is in a Phase II/III clinical trial for the treatment of Amyloid A
Amyloidosis. Alzhemed(TM) and Cerebril(TM) have completed a Phase II clinical
trial for the treatment of 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).
This news release contains forward-looking statements regarding the potential
for Cerebril(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.
Promising results and successes in early stage clinical trials do not ensure
that later stage or larger scale clinical trials will be successful. For
instance, Cerebril(TM) may not show the same benefits, results or safety profile
in later stage or larger scale clinical trials. Unexpected concerns may arise
during clinical trials or in the course of developing Cerebril(TM), which would
delay the start of later stage or larger scale clinical trials. 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.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Lise Hebert, Ph.D.
Vice President, Corporate Communications
lhebert@neurochem.com
- ---------------------
Tel: (514) 337-4646
Fax: (514) 337-5339