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May 19, 2004
Annual General Meeting of Shareholders. Fibrillex™ Expected to Receive Approval in late 2005
Dr. Bellini pointed out that Fibrillex™, Neurochem's most advanced investigational product
candidate, is expected to receive regulatory approval in late 2005. Fibrillex™ is for the
treatment of Amyloid A (AA) Amyloidosis, a serious consequence of chronic inflammatory and infectious
diseases, such as Rheumatoid Arthritis. The market potential in industrialized countries is
evaluated at between US$500 million and $1 billion. Last month, Neurochem received a fourth
consecutive unanimous recommendation from its independent Data Safety Monitoring Board of medical
experts to continue the Phase II/III trial. Fibrillex™ has been granted Fast Track Product
designation by the U.S. Food and Drug Administration. This designation is granted to expedite
development and review of a new drug intended for the prevention or treatment of a serious or
life-threatening condition. Fibrillex™ has already received orphan drug status in the United
States and Europe which normally provides a product, upon market entry, with seven years of market
exclusivity in the U.S. and 10 years in Europe. Alzhemed™ to Begin Phase III Trials
Large-scale Phase III clinical trials for Alzhemed™, Neurochem's investigational product candidate
designed to stop the progression of Alzheimer's Disease (AD), are scheduled to begin in June 2004 in
North America and early 2005 in Europe. Each of the 18-month Phase III trials for Alzhemed™ will
involve some 950 mild-to-moderate AD patients. Cerebril™ to Begin a Phase II Trial to Test Efficacy in 2005
Following promising results from the successful completion of the Phase II clinical trial made public
at the recent annual meeting of the American Academy of Neurology, Neurochem's third program with
Cerebril™, designed to prevent the recurrence of Hemorrhagic Stroke due to Cerebral Amyloid
Angiopathy, is planned to advance to a second Phase II trial in 2005 to test its efficacy in
preventing recurring strokes caused by amyloid. The first Phase II trial revealed no safety findings
of concern and the pharmacokinetic profile of the drug candidate was well characterized. Cerebril™
was detected in the cerebrospinal fluid of the patients, suggesting its ability to cross the
blood-brain-barrier. Future Outlook
The Company's overall activities will continue to be geared towards maintaining its leadership role
in the development of therapeutics for neurological disorders. As Neurochem approaches the completion
of the Phase II/III clinical trial for Fibrillex™, and the initiation the Phase III clinical
trials for Alzhemed™, the Company will work to maintain its strong growth by enhancing its
management and product development resources and its marketing and sales infrastructure. About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics for
neurological disorders. The Company's pipeline of proprietary, disease-modifying, oral products
addresses critical, unmet medical needs. Fibrillex™, designated as an orphan drug and as a
Fast Track Product candidate, is in a Phase II/III clinical trial for the treatment of Amyloid A
Amyloidosis. Alzhemed™ and Cerebril™, for the treatment of Alzheimer's Disease and for
the prevention of Hemorrhagic Stroke caused by Cerebral Amyloid Angiopathy, respectively, have both
completed a Phase II clinical trial. For additional information on Neurochem, please visit our
website at: (www.neurochem.com).
Certain statements contained in this news release, other than statements of fact that are
independently verifiable at the date hereof, may constitute forward-looking statements. Such
statements, based as they are on the current expectations of management, inherently involve
numerous risks and uncertainties, known and unknown, many of which are beyond Neurochem's control.
Such risks include but are not limited to: 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 as well as other risks included
in public filings of Neurochem. Consequently, actual future results may differ materially from
the anticipated results expressed in the forward-looking statements. The reader should not place
undue reliance on the forward-looking statements included in this news release. These statements
speak only as of the date made and Neurochem is under no obligation and disavows any intention to
update or revise such statements as a result of any event, circumstances or otherwise.
For further Information, please contact: |
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