Genzyme regulatory update

Genzyme issued a "Dear Healthcare Practitioner" letter and FDA warned healthcare professionals about the potential for foreign particle contamination in five Genzyme products. The five products - Cerezyme imiglucerase for Gaucher's disease; Fabrazyme agalsidase beta for Fabry's disease; Myozyme alglucosidase alfa for Pompe's disease; Thyrogen thyrotrophin alpha for thyroid cancer; and Aldurazyme laronidase, a mucopolysaccharidosis I (MPS I) drug partnered with BioMarin Pharmaceutical Inc. (NASDAQ:BMRN, Novato, Calif.) - were all filled at Genzyme's Allston, Mass., manufacturing facility. FDA said the particles are believed to be found in less than 1% of the products and include non-latex rubber from the vial stopper, stainless steel fragments and fiber-like material. The agency said the particles could potentially cause serious adverse events; however, no adverse events reports have been received to date.

FDA will allow Genzyme to continue to market the products, saying that it is "acutely aware of the critical need for patients to have continued access" to the drugs. The agency said it is investigating the contamination and "seeking immediate implementation of corrective actions." It also recommended steps to be taken by practitioners to reduce the risk of administering a contaminated product. ...