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February 13, 2006
Neurochem submits NDA for Fibrillex About the Phase II/III clinical trial
The Phase II/III clinical trial for Fibrillex was a two-year, international, multi-center, randomized, double-blind,
placebo-controlled, and parallel-designed trial to evaluate the safety and efficacy of Fibrillex in patients
suffering from AA amyloidosis. Neurochem enrolled 183 patients for this trial, which was conducted at 27 sites located
across North America, Europe and Israel. About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics to address critical unmet
medical needs. Eprodisate (Fibrillex) is designated as an orphan drug, is a Fast Track product candidate and is
also part of FDA Continuous Marketing Application Pilot 1 and Pilot 2 programs. The Phase II/III clinical trial of
Fibrillex for the treatment of AA amyloidosis was concluded in April 2005. The Company has completed its submission
of a New Drug Application for Fibrillex that the FDA agreed in June 2005 to file and review. Tramiprosate
(Alzhemed), for the treatment of Alzheimer's disease, is currently in Phase III clinical trials in both North
America and Europe and tramiprosate (Cerebril), 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), 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 Fibrillex 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, please contact: |
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