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: December, 2007
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
¨
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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December 7, 2007
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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:
Lise Hébert, Ph.D.
Vice President, Corporate Communications
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Tel: 1-450-680-4570
lhebert@neurochem.com
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NEUROCHEM ANNOUNCES EPRODISATE (KIACTA) RECEIVES
ACKNOWLEDGEMENT OF COMPLETE RESPONSE AND
IS GRANTED CLASS 2 REVIEW
ECUBLENS, SWITZERLAND December 6, 2007
Neurochem (International) Limited (Neurochem), a
wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX; TSX: NRM), announces that the Company has
received an acknowledgement from the United States Food and Drug Administration (FDA) that
Neurochems response to the July 2007 approvable letter for the New Drug Application (NDA) for
eprodisate (KIACTA) for the treatment of Amyloid A (AA) amyloidosis is a complete, Class 2
response. The PDUFA (Prescription Drug User Fee Act) goal date by which the FDA is expected to
render a decision is April 2, 2008.
The NDA for approval of eprodisate (KIACTA) for the treatment of AA amyloidosis was filed in
February 2006. The Company submitted its response to the second approvable letter last September
and this response has been acknowledged as complete by the FDA, allowing for the Class 2 review.
We look forward to further productive interactions with the FDA as we enter late-stage discussions
on our marketing application, said Dr. Francesco Bellini, Neurochem Inc.s Chairman, President and
CEO.
About eprodisate (KIACTA)
Eprodisate (KIACTA
TM
) 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
TM
) for more
than six years.
In September 2006, the European Medicines Agency (EMEA) confirmed that it had commenced a
regulatory review of eprodisate (KIACTA). The Marketing Authorization Application is being
reviewed under the Agencys centralized
procedure. This means that an authorization from this Agency would apply to all 27 European Union
member states, as well as to Norway and Iceland. An oral hearing occurred with the EMEA in November
2007 to discuss outstanding issues raised with respect to the
eprodisate (KIACTA) application and
a decision from the EMEA is expected by year-end, or shortly thereafter.
The Company also filed for marketing approval for eprodisate (KIACTA) for the treatment of AA
amyloidosis in Switzerland. A decision is expected in 2008.
Eprodisate (KIACTA
TM
) has received orphan drug status in the United States, the European
Union and in Switzerland.
Neurochem Inc. sponsored the EFAAT study.
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 Inc.
Neurochem Inc. is a global health company focused on the research, development and
commercialization of products to provide innovative health solutions to patients suffering from
serious diseases.
To Contact Neurochem Inc.
For additional information on Neurochem and its drug development programs, please call the North
American toll-free number 1 877 680-4500 or visit the 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 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. Please see the Annual
Information Form of Neurochem Inc. for further risk factors that might affect the Neurochem group
and its business.