GENZYME SEEKING EURO APPROVAL OF CEREDASE

Presently approved in the USA as an enzyme replacement therapy for patients with Gaucher disease type I, Genzyme Corp's Ceredase (alglucerase) is now being used on a "compassionate use basis" prior to approval in the UK and other European countries in a small number of severely-ill Gaucher disease patients.

Genzyme notes that Ceredase is the only pharmaceutical product available for treating patients with this disease, a rare, seriously debilitating and potentially life-threatening disorder caused by a deficiency of beta-glucocerebrosidase. Ten patients in the UK are currently receiving the treatment. However, an estimated 2,000-3,000 patients in Europe could benefit from treatment with the drug.

The company notes that the marketing approval application is presently being reviewed in the Netherlands and the pre-assessment process is expected to take about three months, after which the Netherlands will liaise with Europe's Committee for Proprietary Medicinal Products.