More bad news for Genzyme as US FDA delays Lumizyme application

US biotechnology major Genzyme, which just a day earlier revealed that the US Food and Drug Administration found that vials of five drugs marketed by the company were found to be contaminated. (The Pharma Letter November 16), faced another setback when the agency said it would not approve the firm's Lumizyme (alglucosidase alfa) for the treatment of Pompe, a rare muscle disorder, until it addresses manufacturing deficiencies at its Allston Landing plant in Boston which impacted the other products.

Genzyme said that it has received a complete response letter from the FDA regarding its application to market Lumizyme, in which the agency stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved. Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed.

The FDA completed its five-week inspection of the Allston plant last Friday, and provided Genzyme with a Form-483 outlining remaining deficiencies, which were mainly related to the fill/finish capabilities at the facility. The FDA has indicated a willingness to work with Genzyme to resolve these issues and to ensure continued product supply. Genzyme's plan to address these deficiencies includes establishing additional internal controls and updating fill/finish capabilities in Allston, transferring additional filling activities to existing Genzyme contract manufacturers, and utilizing excess capacity at the firm's manufacturing facility in Waterford, Ireland.

The state-of-the-art Waterford facility is undergoing a major expansion, with engineering runs scheduled to begin in early next year. This expansion will increase Genzyme's internal filling capacity by four fold. Cerezyme (imiglucerase for injection) 400-unit vials, which supply over 80% of patients worldwide, will be filled exclusively in Waterford moving forward.

Meantime, Lumizyme is now being produced at the company's larger-scale facility in Geel, Belgium, in order to meet global demand, the company said.