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October 31, 2000
Neurochem files for Orphan Medicinal product designation in Europe for
Fibrillex™
Neurochem Inc. (TSX : NRM) has filed for "Orphan Medicinal Product" (OMP)
designation with the European Agency for the Evaluation of Medicinal Products (EMEA)
for Fibrillex™, a drug under development for
the treatment of patients suffering from Secondary Amyloidosis. The OMP designation in
Europe typically allows a 10-year market exclusivity in the 15 Member States of the
European Community
"Neurochem has achieved several important milestones in the drug development
process for Fibrillex™," said Dr. Louis R. Lamontagne, Neurochem's
President and CEO. "This filing for Orphan Medicinal Products status in Europe,
follows the recent granting of Investigational New Drug (IND) status by the FDA in the
United States earlier this month. This is good news for people suffering from amyloidosis.
While no cure currently exists, these authorizations will facilitate the process of bringing
Fibrillex™ to market in the U.S. and Europe more efficiently in order to treat
the patients who presently suffer from this serious disease."
The provisions of the Orphan Medicinal Products regulation in the European Community
are intended to stimulate the research, development and availability of products that
prevent or treat life-threatening or chronically debilitating diseases for which there
is a lower prevalence but nevertheless require effective treatment. Neurochem already
received Orphan Drug Designation (ODD) from the FDA for Fibrillex™ granting
the product a 7-year market exclusivity in the U.S. upon commercialization. In addition
to the typical 10-year market exclusivity granted under the OMP program in Europe, Neurochem
could receive other incentives which include possible access to research assistance to
defray the costs of clinical testing.
Secondary Amyloidosis is a systemic and fatal form of amyloidosis. The disease is caused
by the deposition of amyloid A (AA) protein mainly in the kidneys, the spleen, the liver
and the adrenals causing severe dysfunction. It is associated with chronic inflammatory
conditions such as rheumatoid arthritis, chronic infections and Familial Mediterranean
Fever. It is estimated that more than 500,000 patients in industrialized countries are
presently suffering from Secondary Amyloidosis, with no treatment available.
With the granting of IND status in the U.S. earlier this month, Fibrillex™ is
now entering in pivotal Phase II/III clinical trials. Fibrillex™ has undergone
extensive toxicity and pharmacokinetic investigations in animal species and exhibited a
good safety profile. The drug's safety, tolerability and pharmacokinetic profile was
re-confirmed in the four human clinical Phase I studies conducted previously.
Neurochem is an industry leader in the development of a novel, proprietary series of
compounds that inhibit the formation, deposit and toxic effects of amyloid fibrils on
cells within the body. Neurochem's research team has been working with international
amyloid experts on the development of therapeutic cures to amyloid-related diseases,
including Alzheimer's disease, Secondary Amyloidosis , Diabetes Type II and Hemorrhagic
Stroke (due to Cerebral Amyloid Angiopathy). Neurochem has advanced three drug candidates to
clinical trials: Alzhemed™, for the treatment of Alzheimer's disease,
Fibrillex™, for Secondary Amyloidosis, and Cerebril™, for
Hemorrhagic Stroke. At present, the Company employs over 50 people and is located in
Saint-Laurent, Canada (www.neurochem.com).
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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