Genzyme regulatory update

GENZ's Ceradase received a recommendation for approval from the European Community's Committee for Proprietary Medicinal Products to treat Type 1 Gaucher disease. The Cambridge, Mass., company said it has begun the regulatory process in all European countries.

Greg Phelps, senior vice president, said the average annual cost for the enzyme-replacement therapy is about $140,000, depending on the severity of the disease. Phelps said the average European price per unit will be about $4.25, whereas the average of the base prices in the U.S., Israel and Australia, where the drug also is approved, is $3.75. Phelps said the European price is higher because of import duties, taxes and regulatory costs. The Ceradase unit is not a volume-based measure; it is based on the enzyme activity, or the drug potency in the unit. ...