Newsroom 2006
Attention Business/Financial Editors:
Neurochem Marketing Authorization Application for Kiacta(TM) accepted for review by EMEA
ECUBLENS, Switzerland, Sept. 28 /CNW Telbec/ - Neurochem (International)
Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ:
NRMX; TSX: NRM), announces today that its Marketing Authorization Application
(MAA) for eprodisate (Kiacta(TM); formerly Fibrillex(TM)) has been validated
by the European Medicines Agency (EMEA), which confirms that the regulatory
review has started. The Company is seeking marketing approval of its
investigational product candidate, Kiacta(TM), for the treatment of Amyloid A
(AA) amyloidosis in the European Union (EU).
The MAA for Kiacta(TM) will be reviewed under the Centralized Procedure,
where marketing authorization is applied for all EU Member States (numbering
25 countries today), plus Norway and Iceland. Kiacta(TM) has been designated
as an Orphan Medicinal Product in Europe, which normally provides ten years of
market exclusivity upon regulatory approval.
"Neurochem looks forward to working with the European Authorities as they
begin the review process for Kiacta(TM) as a potential and specific treatment
for AA amyloidosis," said Dr. Francesco Bellini, Chairman, President and Chief
Executive Officer of Neurochem Inc. "We remain committed to the advancement of
this product candidate with the hope of making it available as soon as
possible to the doctors and the patients who could benefit from Kiacta(TM)."
In August 2006, Neurochem Inc. received an approvable letter from the
U.S. Food and Drug Administration (FDA) for Kiacta(TM) for the treatment of AA
amyloidosis. Neurochem Inc. plans to respond to the FDA and submit an
amendment to the New Drug Application shortly.
Neurochem has an exclusive collaboration and distribution agreement for
Kiacta(TM) with Centocor, Inc.
About Kiacta(TM)
Kiacta(TM) was investigated in a landmark international, randomized,
double-blind, placebo-controlled, and parallel-designed clinical trial in
which 183 patients were enrolled at 27 sites around the world. Patients who
completed the clinical trial were eligible for enrollment in an ongoing
open-label extension 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 and end stage renal
disease is the most common cause of death 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 focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(Kiacta(TM)) is currently being developed for the treatment of AA amyloidosis,
and is under regulatory review for marketing approval by the U.S. Food and
Drug Administration and European Medicines Agency. Tramiprosate
(Alzhemed(TM)), for the treatment of Alzheimer's disease, is currently in
Phase III clinical trials in both North America and Europe and tramiprosate
(Cerebril(TM)), for the prevention of Hemorrhagic Stroke caused by Cerebral
Amyloid Angiopathy, has completed a Phase IIa clinical trial.
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.
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This news release contains forward-looking statements regarding
eprodisate (Kiacta(TM)), as well as regarding continuing and further
development efforts. These statements are based on the current analysis and
expectations of management. Drug development necessarily involves numerous
risks and uncertainties, which could cause actual results to differ materially
from this current analysis and these expectations. Analysis regarding the
results of clinical trials may not provide definitive results regarding
safety, tolerability or therapeutic benefits. Even if all the endpoints sought
in the clinical trials were met (which is not certain), there is no certainty
that regulators would ultimately approve eprodisate (Kiacta(TM)) for sale to
the public. Risks and uncertainties may include: failure to demonstrate the
safety, tolerability and efficacy of our product, the expense and uncertainty
of obtaining regulatory approval, including from the FDA, and the possibility
of having to conduct additional clinical trials. Further, even if regulatory
approval is obtained, therapeutic products are generally subject to: stringent
on-going governmental regulation, challenges in gaining market acceptance, and
competition. Neither Neurochem Inc., nor Neurochem (International) Limited
undertake any obligation to publicly update any forward-looking statements,
whether as a result of new information, future events, or otherwise. Please
see Neurochem Inc.'s Annual Information Form for further risk factors that
might affect Neurochem Inc., Neurochem (International) Limited and their
respective businesses.
For further information: Lise Hébert, Ph.D., Vice President, Corporate
Communications, (450) 680-4570, lhebert@neurochem.com
