Neurochem Inc - Report of Foreign Issuer (6-K)
14 Dezember 2007 - 9:51PM
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: 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 14, 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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The Material Change Report dated December 14, 2007, issued by Neurochem Inc. (the “Registrant”)
submitted with this Form 6-K is hereby incorporated by reference into, and as an exhibit to, the
Registrant’s registration statements on Form F-10 (SEC Reg. Nos. 333-140039 and 333-142770).
FORM 51-102F3
MATERIAL CHANGE REPORT
Item 1
Name and Address of Company
Neurochem Inc. (“Neurochem”)
275 Armand-Frappier Blvd.
Laval, Québec
H7V 4A7
Item 2
Date of Material Change
Item 3
News Release
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A press release was disseminated by CNW Telbec on December 14, 2007 from Laval, Québec.
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Item 4
Summary of Material Change
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Neurochem (International) Limited, a wholly-owned subsidiary of Neurochem (together with
Neurochem, the “Company”), announced that the Committee for Medicinal Products for Human
Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a
negative opinion recommending refusal of the marketing authorization application (MAA) for
eprodisate (KIACTA
TM
).
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Item 5
Full Description of Material Change
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5.1
Full Description of Material Change
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On December 14, 2007, the Company announced that the CHMP, the scientific committee of the
EMEA, has issued a negative opinion recommending refusal of the MAA for eprodisate
(KIACTA
TM
) for the treatment of Amyloid A amyloidosis and concluding that
another study would be needed to demonstrate eprodisate’s (KIACTA™) effectiveness. The
Company is currently reviewing all of its options in view of this opinion, including the
option of requesting a re-examination of the opinion by CHMP. As provided by the European
regulations, the Company may request that the CHMP consult a Scientific Advisory Group in
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connection with the re-examination. The deadline for filing any such request is within
fifteen days of receipt of notification of the opinion.
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5.2
Disclosure for Restructuring Transactions
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Item 6
Reliance on subsection 7.1(2) or (3) of National Instrument 51-102
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This report is not being filed on a confidential basis.
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Item 7
Omitted Information
Item 8
Executive Officer
Dr. Lise Hébert
Vice-President, Corporate Communications
450.680.4572
Item 9
Date of Report
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For
further information, please contact:
Lise Hébert, PhD
Vice President, Corporate Communications
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Tel: (450) 680-4572
lhebert@neurochem.com
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NEUROCHEM ANNOUNCES EUROPEAN OPINION FOR EPRODISATE
(KIACTA™) FOR THE TREATMENT OF AA AMYLOIDOSIS
ECUBLENS, SWITZERLAND, December 14, 2007 —
Neurochem (International) Limited (Neurochem), a
wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX; TSX: NRM), announces that the Committee
for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines
Agency (EMEA), has issued a negative opinion recommending refusal of the marketing authorization
application (MAA) for eprodisate (KIACTA
TM
) for the treatment of Amyloid A (AA)
amyloidosis and concluding that another study would be needed to demonstrate eprodisate’s (KIACTA™)
effectiveness. The Company is currently reviewing all of its options in view of this opinion,
including the option of requesting a re-examination of the opinion by CHMP. As provided by the
European regulations, the Company may request that the CHMP consult a Scientific Advisory Group
(SAG) in connection with the re-examination.The deadline for filing any such request is within
fifteen days of receipt of notification of the opinion.
“We are naturally disappointed with this opinion for KIACTA
TM
as we are acutely aware of
the needs of AA amyloidosis patients who have no specific therapy presently available,” said Dr.
Francesco Bellini, Neurochem Inc.’s Chairman, President and CEO. “In view of the clinical benefit
KIACTA
TM
has shown on the kidney function of patients, we are considering making a
request for re-examination of the opinion which could lead to a decision as early as the second
quarter of 2008. We look forward to further productive interactions with the EMEA,” he concluded.
U.S. New Drug Application (NDA)
In the U.S., Neurochem Inc. received an acknowledgement from the Food and Drug Administration (FDA)
that the Company’s response to the second approvable letter of July 2007 for the NDA for eprodisate
(KIACTA™) for the treatment of 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.
About eprodisate (KIACTA
TM
)
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 international sites (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. Eprodisate (KIACTA
TM
) has received orphan drug status in the United
States, the European Union and in Switzerland.
The Company also filed for marketing approval for eprodisate (KIACTA™) for the treatment of AA
amyloidosis in Switzerland. A decision is expected in 2008.
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 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 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.
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