Genzyme receives positive opinion for Cholestagel

Genzyme Corp has received a positive opinion on the company's application to market Cholestagel (colesevelam hydrocholoride), a novel, non-absorbed cholesterol-lowering agent for the treatment of primary hypercholesterolemia (elevated cholesterol).

The positive Committee for Proprietary Medicinal Products (CPMP) opinion is the final step before formal approval to market Cholestagel in the 15 countries of the European Union. The committee's opinion will be forwarded to the EC, which is expected to make a final decision on the authorisation before the end of the first quarter of 2004. The Commission generally follows the advice of the CPMP, but it is not obliged to do so.

Genzyme submitted the Marketing Authorisation Application to the European Agency for the Evaluation of Medicinal Products (EMEA) on August 30, 2002. Colesevelam hydrochloride has been marketed in the United States under the brand-name WelChol for three years by Genzyme's U.S. marketing partner for the product, Sankyo Pharma Inc. In Europe, Genzyme is exploring options for making the product available to patients. The company does not expect European sales of Cholestagel to contribute materially to earnings in the short term.

'We are pleased to receive the CPMP's opinion, which underscores the role that Cholestagel may play in the management of hypercholesterolemic patients in Europe,' said Dr Carlo Incerti, senior vice president of biomedical and regulatory affairs in Europe. 'We look forward to the opportunity to make this treatment available to patients who would benefit from it.'

Cholesterol

Colesevelam hydrochloride is a non-absorbed, lipid-lowering agent specifically engineered to efficiently bind bile acids in the intestine, impeding their reabsorption. This process - called bile acid sequestration - initiates a series of events that results in an increased clearance of LDL cholesterol in the blood. Colesevelam hydrochloride's ability to lower serum LDL cholesterol levels was demonstrated in eight clinical trials with approximately 1,600 patients and treatment durations ranging from 4 to 50 weeks. Those trials also demonstrated the product's ability to increase levels of HDL cholesterol. The product was found to be effective as a monotherapy for patients with mild to moderate hypercholesterolemia. In combination studies of the product with a leading statin, results show the two work better together than either one alone. The studies were conducted with atorvastatin (Lipitor), lovastatin (Mevacor) or simvastatin (Zocor).