Neurochem granted Fast Track designation from U.S. FDA for tramiprosate (ALZHEMED(TM))
Neurochem to meet with FDA to discuss statistical models for the
completed North American Phase III clinical trial
LAVAL, QC, July 24 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)
announces that the U.S. Food and Drug Administration (FDA) has designated the
investigational product candidate, tramiprosate (ALZHEMED(TM)), as a Fast
Track Product for the treatment of Alzheimer's disease.
Under the FDA Modernization Act of 1997, the Fast Track designation
program is intended to facilitate the development and expedite review of drugs
developed for the treatment of serious or life-threatening conditions and that
demonstrate the potential to address an unmet medical need for such a
condition.
As previously announced, Neurochem requested a meeting with the FDA,
which is now scheduled for August 2007 with the Division of Neurology
Products. The goal of this meeting is to have a discussion on the tramiprosate
(ALZHEMED(TM)) Phase III program and present an update on the work
accomplished to date on the North American Phase III clinical trial. Neurochem
will also seek FDA's feedback and validation on the next steps that would be
acceptable to the agency especially with respect to the statistical models. In
relation to the ongoing European Phase III clinical trial, patient screening
activities will stop in August as Neurochem has exceeded its original patient
enrolment objectives. However, in light of the information and experience
gained from the North American Phase III clinical trial, Neurochem is
presently considering modifications that would need to be made to the design
of the European trial.
About Alzheimer's disease
AD is a leading cause of death in older people. The disease is
characterized by the progressive death of nerve cells in the brain, making it
difficult for the brain's signals to be transmitted properly. A person with AD
experiences problems with memory, judgment, thinking, and eventually with
motor functions, all of which make it difficult for the person to participate
in daily activities.
According to the U.S. Alzheimer Association (2007), there are now more
than five million people in the United States living with Alzheimer's disease.
This number includes 4.9 million people aged 65 and older. It also includes at
least 200,000 individuals younger than 65 with early-onset Alzheimer's
disease. In 2000, there were an estimated 411,000 new cases of Alzheimer's
disease. That number is expected to increase to 454,000 new cases a year by
2010, 615,000 new cases a year by 2030 and 959,000 new cases a year by 2050.
The direct and indirect costs of AD and other dementias amount to more than
US$148 billion annually.
About Neurochem
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 Amyloid A (AA)
amyloidosis, and is under regulatory review for marketing approval by the
United States Food and Drug Administration, European Medicines Agency and
Swissmedic. Tramiprosate (ALZHEMED(TM)), for the treatment of Alzheimer's
disease, has completed a Phase III clinical trial in North America and is
currently in a Phase III clinical trial in Europe, while 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
tramiprosate (ALZHEMED(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 tramiprosate (ALZHEMED(TM)) for sale
to the public. Risks and uncertainties may include: failure to demonstrate the
safety, tolerability and efficacy of our product, that actual results may vary
once the final and quality-controlled verification of data and analyses has
been completed, 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, Ph.D., Vice President, Corporate Communications, (450) 680-4570, lhebert@neurochem.com
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