CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corp. (Nasdaq: GENZ) announced today that it has issued letters to U.S. healthcare providers regarding its enzyme replacement products Cerezyme® (imiglucerase for injection), Fabrazyme® (agalsidase beta), Myozyme® (alglucosidase alfa), Aldurazyme® (laronidase), as well as Thyrogen® (thyrotropin alfa for injection), filled at its Allston Landing manufacturing facility. The letters remind providers of the U.S. product labeling recommendations advising both visual inspection of vials and in-line filtration of enzyme replacement products to address the potential presence of foreign particles.
The safety profile of these products remains unchanged. A review of the global safety database for these products has not identified any safety concerns to suggest that patients treated with Genzyme products have been exposed to foreign particles. However, a theoretical safety risk remains should a particle enter the bloodstream.
Genzyme’s quality control processes have detected foreign particles in these products at a rate of approximately 1 percent. The company’s rate has not increased over time. The global rate of product returns from customers due to the observance of foreign particles is less than approximately 0.02 percent for these products. Genzyme remains committed to reducing the frequency of foreign particles in all of our products.
The healthcare provider letters are available on the company’s product websites.
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion.
With many established products and services helping patients in approximately 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme®, Cerezyme®, Fabrazyme®, Myozyme®, Thyrogen® are registered trademarks of Genzyme Corporation or its subsidiaries. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC. All rights reserved.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.