Neurochem Inc - Report of Foreign Issuer (6-K)
14 3월 2008 - 4:25AM
Edgar (US Regulatory)
TABLE OF CONTENTS
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: March, 2008
Commission File Number: 000-50393
NEUROCHEM INC.
275 Armand-Frappier Boulevard
Laval, Québec
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
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Form 40-F
þ
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
þ
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
þ
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
þ
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.
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NEUROCHEM INC.
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March 13, 2008
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By:
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/s/ David Skinner
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David Skinner, Vice-President
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General Counsel and Corporate Secretary
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For further information, please contact:
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Lise Hébert, PhD
Vice President, Corporate Communications
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Tel: (450) 680-4572
lhebert@neurochem.com
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NEUROCHEM MOVES EPRODISATE (KIACTA
TM
) DRUG DEVELOPMENT
PROGRAM FORWARD FOR AMYLOID A AMYLOIDOSIS
ECUBLENS, SWITZERLAND, March 13, 2008
Neurochem (International) Limited (Neurochem), a
wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX; TSX: NRM), announces that the Company is
taking new initiatives to pursue the drug development program for its investigational product
candidate, eprodisate (KIACTA), to obtain market approval for the treatment of Amyloid A (AA)
amyloidosis. Neurochems decision to build upon its eprodisate (KIACTA) asset and take steps to
initiate a second Phase III clinical trial is based principally on the fact that AA amyloidosis is
a life-threatening disease for which there is no specific treatment, on the data obtained from the
first Phase II/III clinical trial, which yielded promising efficacy results on the study endpoints,
on the benign safety profile of eprodisate (KIACTA) in patients diagnosed with AA amyloidosis, and
on its discussions with the regulatory agencies and related scientific advisory committees. As part
of the approval process for the investigational product candidate, both the regulatory agencies in
the United States and in the European Union recommended an additional confirmatory efficacy Phase
III clinical trial, which will have a target significance level (p-value) of 0.05 rather than the
p-value of 0.01, which had been required for an approval based on a single efficacy study. Based
on these recommendations, the Company will enter into discussions with the U.S. Food and Drug
Administration (FDA) and with the European Medicines Agency (EMEA) to reach agreement on the terms
for an approval of eprodisate (KIACTA) for the treatment of AA amyloidosis. As part of this
strategic decision, the Company is also announcing that it is withdrawing its current marketing
applications for eprodisate (KIACTA) in the United States, the European Union and Switzerland.
This strategy reflects the advice the Company has received from the regulatory authorities about
its marketing applications, and is in line with our efforts over the past two years and allows the
Company to pursue its objective of making KIACTA available to patients as soon as possible. The
FDA and EMEA have both acknowledged that the first Phase II/III clinical trial provided some
evidence of the effectiveness of KIACTA in the treatment of the renal manifestations of
amyloidosis. Accordingly, we look forward to productive discussions with the regulatory agencies
and hope to initiate the second Phase III study in the very near future, said Dr. Francesco
Bellini, Chairman, President and Chief Executive Officer of Neurochem Inc.
-2-
The applications for marketing authorization for eprodisate (KIACTA) were submitted in the United
States, the European Union and in Switzerland in February, September and November 2006,
respectively.
About eprodisate (KIACTA)
Eprodisate (KIACTA) was investigated in an international, randomized, double-blind,
placebo-controlled, and parallel-designed Phase II/III clinical trial in which 183 AA amyloidosis
patients were enrolled at 27 sites around the world (Eprodisate for AA Amyloidosis Trial, EFAAT).
Patients who completed the clinical trial were eligible for enrollment in an ongoing open-label
extension study, some of whom have now been receiving eprodisate (KIACTA) for more than six years.
The completion of the extension study is scheduled for April 2008. Neurochem Inc. sponsored the
EFAAT study.
Eprodisate (KIACTA) has received orphan drug status in the United States and the European Union,
which normally provide seven and ten years of market exclusivity, respectively, upon regulatory
approval.
About Amyloid A (AA) Amyloidosis
A progressive and fatal condition, AA amyloidosis 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 and progression to dialysis/end-stage renal
disease is the most common clinical manifestation in this disease. Currently, there is no approved
therapy to treat AA amyloidosis and about half of all patients diagnosed with the disease die
within five years of diagnosis.
About Neurochem
Neurochem Inc. is a global health company focused on the research, development and
commercialization of products to provide innovative health solutions to address critical unmet
medical needs.
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
.
Certain statements contained in this news release, other than statements of fact that are
independently verifiable at the date hereof, may constitute forward-looking statements. Such
statements, based as they are on the current expectations of management, inherently involve
numerous risks and uncertainties, known and unknown, many of which are beyond the Companys and
Neurochem Inc.s control. Such risks include but are not limited to: the impact of general economic
conditions, general conditions in the pharmaceutical and/or nutraceutical industry, changes in the
regulatory environment in the jurisdictions in which the Neurochem group does business, stock
market volatility, fluctuations in costs, and changes to the competitive environment due to
consolidation, that actual results may vary once the final and quality-controlled verification of
data and analyses has been completed, as well as other risks disclosed in public filings of
Neurochem Inc. Consequently, actual future results may differ materially from the anticipated
results expressed in the forward-looking statements. The reader should not place undue reliance, if
any, on any forward-looking statements included in this news release. These statements speak only
as of the date made and Neurochem Inc.
is under no obligation and disavows any intention to update or revise such statements as a result
of any event, circumstances or otherwise, unless required by applicable legislation or regulation.
Please see the Annual Information Form of Neurochem Inc. for further risk factors that might affect
the Neurochem group and its business.
Neurochem (NASDAQ:NRMX)
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