Neurochem moves eprodisate (KIACTA(TM)) drug development program forward for Amyloid A amyloidosis



    ECUBLENS, SWITZERLAND, March 13 /CNW Telbec/ - 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(TM)), to obtain market approval for the treatment of
Amyloid A (AA) amyloidosis. Neurochem's decision to build upon its eprodisate
(KIACTA(TM)) 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(TM)) 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(TM)) 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(TM)) 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(TM) 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(TM) 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.
    The applications for marketing authorization for eprodisate (KIACTA(TM))
were submitted in the United States, the European Union and in Switzerland in
February, September and November 2006, respectively.

    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 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. The completion of the extension
study is scheduled for April 2008. Neurochem Inc. sponsored the EFAAT study.
    Eprodisate (KIACTA(TM)) 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 Company's 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.




For further information:

For further information: Lise Hébert, PhD, Vice President, Corporate
Communications, (450) 680-4572, lhebert@neurochem.com


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