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December 11, 2002
Annual General and Special Shareholders' Meeting
Neurochem has successfully completed the enrollment of patients for the ongoing
Fibrillex™ trial.
At its annual and special meeting of shareholders today, Neurochem Inc. (TSX : NRM) announced
that it has successfully completed the enrollment of the 150 patients required for its
pivotal phase II/III trial for Fibrillex™, the Company's most advanced product candidate.
These patients have been recruited in 27 sites located in North America, Europe and Israel.
Fibrillex™ is being developed for the treatment of Secondary Amyloidosis, a disease for
which no cure exists and that often results in kidney failure, among other clinical
effects.
In addition, the Company reported on its significant drug development advances accomplished
during the past year and presented to its shareholders its growth strategy to bring forward
Neurochem to a product-driven enterprise with an intense focus on development and
commercialization activities. Dr. Francesco Bellini, Neurochem's Chairman, formerly took on
the additional role of CEO, following the Board meeting. He replaces Dr. Louis R. Lamontagne,
who recently announced that he would step down while remaining a member of Neurochem's
Board and a special advisor to the Company.
"Neurochem has exceptional potential for future growth," said Dr. Bellini.
"We will be setting up our commercial strategy for Fibrillex™ for which there are
no competitive treatments at the present time. Neurochem has also retained full rights to
its products with some 149 patents granted or filed worldwide. We will be working aggressively
to capitalize on those rights beginning with Fibrillex™. Neurochem has a healthy and
expanding pipeline of drug candidates, a highly specialized and dedicated team, a strong
shareholder base and the financial resources to emerge as a promising specialty
pharmaceutical company in North America."
Highlights of Significant Achievements
for Fiscal 2002:
Following are the important highlights of Neurochem's achievements for fiscal 2002:
Fibrillex™
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Prestigious grant from the U.S. Food and Drug Administration received, to help support
development efforts.
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Orphan Drug status granted in Europe. The Company had already received it for the
U.S. meaning that it could have market exclusivity in both territories for the
product once it is commercialized - seven years in the U.S., 10 in Europe.
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13 Investigational New Drug submissions (INDs) in the U.S., Europe and Israel
completed.
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Unanimous recommendation by Neurochem's Data Safety Monitoring Board, composed of
well-experienced independent medical specialists, to advance the trial for
Fibrillex™, based on safety data and the results obtained in patients to date.
Recent developments
Preclinical Development
Alzhemed™
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Alzhemed™, for the treatment of Alzheimer's Disease (AD) has advanced into a
Phase II clinical trial. This study is aimed at determining in mild-to-moderate AD
patients the optimal dosing regimens for subsequent efficacy trials. The trial will
also measure the amyloid protein levels in the plasma and spinal fluids of patients
participating in the study.
Cerebril™
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Cerebril™, for the treatment of Hemorrhagic Stroke due to Cerebral Amyloid
Angiopathy, has also advanced to a Phase II clinical trial. The study will evaluate
the optimal dosing regimens for subsequent efficacy trials and monitor patients
stroke condition by Magnetic Resonance Imagery.
Financing
About Neurochem
Neurochem is an industry leader in the development of therapeutic drugs for central nervous
system (CNS) and amyloid-related disorders. To date, the Company has advanced three drug
candidates into clinical trials: Fibrillex™, for the life-threatening orphan disease,
Secondary Amyloidosis, is in a pivotal Phase II/III clinical trial; Alzhemed™, for the
treatment of Alzheimer's Disease, is in Phase II clinical trials; and Cerebril™ for
Hemorrhagic Stroke, also in Phase II clinical trials. The Company has built a strong product
pipeline by developing a novel, proprietary series of compounds that inhibit the formation,
deposition and toxic effects of amyloid fibrils within the body. Neurochem's overall
therapeutic programs target CNS disorders including Alzheimer's Disease, epileptic seizures
induced by Traumatic Brain Injury, Hemorrhagic Stroke (due to Cerebral Amyloid Angiopathy),
and other life-threatening diseases, including Systemic Amyloidosis and amyloid-associated
Diabetes Type 2 (www.neurochem.com).
All of the statements contained in this news release, other than statements of fact which
are independently verifiable at the date hereof, are forward-looking statements. Such
statements, based as they are on the current expectations of management, inherently involve
numerous risks and uncertainties, known and unknown. Some examples of known risks are: the
impact of general economic conditions, general conditions in the pharmaceutical industry, changes
in the regulatory environment in the jurisdictions in which Neurochem does business, stock
market volatility, fluctuations in costs, and changes to the competitive environment due to
consolidation or otherwise. Consequently, actual future results may differ materially from
the anticipated results expressed in the forward-looking statements.
For further Information, please contact:
Dr. Lise Hébert
Vice President, Corporate Communications
lhebert@neurochem.com
275 Armand-Frappier
Laval (Quebec)
H7V 4A7
Tel: (450) 680-4500
Fax: (450) 680-4501
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