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[news 1999-2000]
FDA
grants investigational new drug status to Queen's Universitys
spinoff Neurochem for Fibrillex™
October 24, 2000
KINGSTON, ON -- Neurochem (TSE:NRM), a Montreal-based
biopharmaceutical company, announced on October 11 that
it received Investigational New Drug (IND) status from
the U.S. Food and Drug Administration (FDA) for its
leading drug candidate FibrillexTM.
Neurochem can now proceed to a pivotal Phase II/III
clinical trial of FibrillexTM, its orally active anti-fibrillary
agent for adult patients suffering from Secondary Amyloidosis.
Secondary Amyloidosis is a systemic and fatal form of
amyloidosis, a condition involving accumulation in bodily
tissues of various insoluble fibrillar proteins in amounts
sufficient to impair normal function. It is associated
with chronic diseases such as Rheumatoid Arthritis,
Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis,
Crohn's Disease and Familial Mediterranean Fever.
It is estimated that more than 500,000 patients in industrialized
countries presently suffer from Secondary Amyloidosis,
with no treatment available.
FibrillexTM was granted Orphan Drug Designation by the
FDA in 1999, ensuring it 7 years of market exclusivity
in the US upon product approval. The market potential
for this treatment is projected to exceed US $500 million
per year.
Neurochem is a spin-off company, stemming from research
conducted at Queen's University and founded by
its technology transfer office, PARTEQ Innovations.
Neurochem was originally formed as a result of licensed
intellectual property developed at Queen's by
Drs. Robert Kisilevsky, Walter Szarek and Donald Weaver.
Neurochem is an industry leader in the development of
novel, proprietary compounds that inhibit the formation,
deposition and toxic effects of amyloid fibrils within
the body. FibrillexTM is one of three drug candidates
advanced by Neurochem to clinical trials, in addition
to AlzhemedTM, for the treatment of Alzheimer's
Disease, and CerebrilTM, for the treatment of Hemorrhagic
Stroke (due to Cerebral Amyloid Angiopathy).
In June of this year, Neurochem completed a Cdn. $36.8
million initial public offering, which is believed to
be the largest biotechnology IPO in Canadian history,
and trades on the Toronto Stock Exchange under the symbol
NRM.
Contact:
John Molloy
President and CEO
PARTEQ Innovations
Phone: (613) 533-2342
Email: molloyj@post.queensu.ca
www.neurochem.com.
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