Neurochem Files A Request To Begin Phase II/III Clinical Trials In U.K. For Fibrillex.

Business Editors, Health/Medical Writers

SAINT-LAURENT, Quebec--(BW HealthWire)--Nov. 8, 2000

Neurochem Inc. (TSE:NRM.) has submitted an application to the Clinical Trials Unit of the Medicines Control Agency in the United Kingdom for initiation of a pivotal Phase II/III clinical study for Fibrillex(TM), an anti-amyloid drug for the treatment of patients suffering from Secondary Amyloidosis.

Fibrillex(TM) has recently been granted Investigational New Drug (IND) status for the initiation of the same pivotal Phase II/III clinical study in the United States by the Food and Drug Administration (FDA). Fibrillex(TM) was previously granted Orphan Drug Designation (ODD) by the FDA which will give it a 7-year market exclusivity in the U.S. upon product approval. Additionally an application for Orphan Medicinal Products (OMP) has been filed with the European Agency for the Evaluation of Medicinal Products (EMEA) in October 2000 which typically allows a 10-year market exclusivity in the 15 Member States of the European Community.

The Phase II/III clinical trial has been designed as a randomized, multinational, double-blind, placebo-controlled, and parallel-design trial. "The study will evaluate the efficacy and safety of the orally active anti-amyloid treatment, Fibrillex(TM), in patients suffering from Secondary Amyloidosis," said Dr. Denis Garceau, Vice-President, Drug Development at Neurochem. "A total of 150 patients will be randomly divided into two arms of equal size (Fibrillex(TM); placebo) and treated over a period of 24 months."

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.

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. 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(TM), for the treatment of Alzheimer's Disease, Fibrillex(TM), in pivotal Phase II/III clinical trial, for Secondary Amyloidosis, and Cerebril(TM), for Hemorrhagic Stroke. Neurochem currently has 8 patents granted and 26 applications filed in the fiscal year ended June 30, 2000. At present, the Company employs over 60 people and is located in Saint-Laurent, Canada (www.neurochem.com).

All of the statements contained in this news release, other than statements of fact, which are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: 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 or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.