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Preliminary Results from Phase 2 Genzyme Study Highlight Potential of Novel Oral Compound for Gaucher Disease
Date:5/7/2008

guidance on the roles that this compound may play in treating and maintaining patients with Gaucher disease."

Genzyme reported the results from the preliminary analysis of the Phase 2 study of Genz-112638 at its Analyst Day meeting held today in Boston.

About Gaucher disease

Gaucher disease is an inherited condition affecting fewer than 10,000 people worldwide. People with Gaucher disease do not have enough of an enzyme that breaks down a certain type of fat molecule called glucocerebrosidase. As a result, cells fill up with the undigested fat in different parts of the body, primarily the liver, spleen and bone marrow. Accumulation of Gaucher cells may cause spleen and liver enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other signs and symptoms. The most common form of Gaucher disease, Type 1, does not affect the brain or nervous system.

About Genz-112638

Genz-112638, a novel glucosylceramide analog given orally, is designed to inhibit the enzyme glucosylceramide synthase, which results in reduced production of glucocerebroside. Glucocerebrosidase is the substance that builds up in the cells and tissues of people with Gaucher disease. In preclinical studies, the molecule has shown high potency and specificity. Based on its mechanism of action, which is independent of genotype, Genz-112638 is a potential therapy for all patients with Type 1 Gaucher disease. Initiation of the Phase 2 study of Genz-112638 in Gaucher disease followed completion of an extensive pre-clinical research effort and a Phase 1 program that involved more than 120 subjects in three separate studies. In addition to Gaucher disease, there are a variety of other conditions including Fabry disease that can be caused by malfunctions in the pathway targeted by this molecule. The compound is exclusively licensed from the University of Michigan and was developed with James A. Shayman, M.D.

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