Newsroom 2006
Attention Business/Financial Editors:
Eprodisate (Fibrillex(TM)) data presented at the meeting of the European League Against Rheumatism (EULAR)
Dr. Hazenberg receives prestigious award on behalf of
eprodisate (Fibrillex(TM)) Study Group
AMSTERDAM, Netherlands, June 22 /CNW Telbec/ - Results from Neurochem's
(NASDAQ: NRMX; TSX: NRM) two-year Phase II/III clinical trial for eprodisate
(Fibrillex(TM)), its investigational product candidate for the treatment of
Amyloid A (AA) amyloidosis, will be presented this week during the annual
meeting of the European League Against Rheumatism (EULAR) by Bouke P.C.
Hazenberg, MD, Division of Rheumatology, Department of Medicine, University
Hospital, Groningen, the Netherlands, and an investigator for the Phase II/III
clinical trial.
"The benefits of Fibrillex(TM) to patients during this clinical trial are
clinically important especially in terms of preserving kidney function. In
addition, its safety profile, comparable to placebo, is very encouraging,"
said Dr. Hazenberg. "With a potential treatment on the horizon and effective
means of diagnosis available, there is a good chance that patients who
demonstrate symptoms will be identified more easily."
Dr. Hazenberg, on behalf of the eprodisate (Fibrillex(TM)) Study Group,
received a clinical science award for the research on the efficacy and safety
of eprodisate (Fibrillex(TM)) in the treatment of patients with AA
amyloidosis. The prestigious EULAR/Abbott Award is given to lead investigators
of the 12 most highly rated abstracts out of the thousands that were submitted
to the organization. Six of the abstracts are in the field of basic science
research and an equal number, applicable to Dr. Hazenberg's case, involve
research in clinical medicine. This award was presented during Wednesday
evening's opening ceremony by EULAR President, Professor Tore K. Kvien, MD.
A poster also to be presented at EULAR by Dr. Hazenberg, assesses the
diagnostic performance of quantifying AA protein in fat tissue of all the
patients in the study and suggests that fat aspiration biopsy is a simple and
reliable method for diagnosing amyloidosis with minimum risks for patients.
Copies of the presentations are available upon request.
About AA amyloidosis
AA amyloidosis is a progressive and fatal condition that occurs in a
proportion of patients with long standing chronic inflammatory disorders,
chronic infections and inherited diseases such as Familial Mediterranean
Fever. The kidney is the organ most frequently affected by AA amyloidosis, and
progression to dialysis and end-stage renal disease is the most common cause
of death in this disease. New approaches to treatment for AA amyloidosis are
urgently needed due to lack of specific therapies.
About eprodisate (Fibrillex(TM))
Eprodisate (Fibrillex(TM)) has been shown to reduce amyloid deposition in
a mouse model of the disease. Results from a completed Phase II/III clinical
trial with AA amyloidosis patients found eprodisate (Fibrillex(TM)) to have a
favorable clinical benefit on renal function/all-cause mortality. The product
candidate was well tolerated and the adverse events profile of eprodisate
(Fibrillex(TM)) was comparable to placebo.
About regulatory submission status of eprodisate (Fibrillex(TM))
While there is no specific treatment approved for use, the new drug
application for eprodisate (Fibrillex(TM)) for the treatment of AA amyloidosis
has been filed and received priority review by the US Food and Drug
Administration (FDA) last April. The FDA is expected to render a decision on
eprodisate (Fibrillex(TM)) around mid-August 2006. Neurochem expects to submit
a Marketing Authorization Application to the European Medicines Agency (EMEA)
in the fall of 2006.
Neurochem has an exclusive collaboration and distribution agreement for
eprodisate (Fibrillex(TM)) with Centocor, Inc.
About Neurochem
Neurochem is focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(Fibrillex(TM)) is designated as an orphan drug, is a Fast Track product
candidate and is also part of the US Food and Drug Administration (FDA)
Continuous Marketing Application Pilot 1 and Pilot 2 programs. In April 2006,
the FDA filed and granted the eprodisate (Fibrillex(TM)) new drug application
priority review. 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.
This news release contains forward-looking statements regarding
eprodisate (Fibrillex(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 (Fibrillex(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. Neurochem does not undertake any obligation to publicly update
its forward-looking statements, whether as a result of new information, future
events, or otherwise. Please see the Annual Information Form for further risk
factors that might affect the Company and its business.
For further information: Lise Hébert, PhD, Vice President, Corporate
Communications, (450) 680-4573, lhebert@neurochem.com