Skip navigation
powered by digg
Genzyme Issues Letters to U.S. Healthcare Providers
By: Business Wire | 13 Nov 2009 | 05:10 PM ET
Text Size

CAMBRIDGE, Mass., Nov 13, 2009 (BUSINESS WIRE) -- Genzyme Corp. (Nasdaq: GENZ) announced today that it has issued letters to U.S. healthcare providers regarding its enzyme replacement products Cerezyme(R) (imiglucerase for injection), Fabrazyme(R) (agalsidase beta), Myozyme(R) (alglucosidase alfa), Aldurazyme(R) (laronidase), as well as Thyrogen(R) (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.

About Genzyme 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(R), Cerezyme(R), Fabrazyme(R), Myozyme(R), Thyrogen(R) are registered trademarks of Genzyme Corporation or its subsidiaries. Aldurazyme(R) 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.

SOURCE: Genzyme Corporation CONTACT: Genzyme Corporation Media Contact: Bo Piela, 617-768-6579 bo.piela@genzyme.com or Investor Contact: Emily Merchant, 617-768-6140 emily.merchant@genzyme.com Copyright Business Wire 2009 -0- KEYWORD: United States

North America

Massachusetts INDUSTRY KEYWORD: Health

Biotechnology

Clinical Trials

Genetics

Hospitals

Oncology

Pharmaceutical

FDA

General Health SUBJECT CODE: Product/Service

Letter

Tools:
Print EmailAdd This share icon


Current DateTime: 01:30:04 01 Dec 2009
LinksList Documentid: 29778428

Current DateTime: 01:04:12 01 Dec 2009
LinksList Documentid: 29779196

Current DateTime: 04:44:44 01 Dec 2009
LinksList Documentid: 29779199

Current DateTime: 07:24:02 01 Dec 2009
LinksList Documentid: 29779198
  Data is a real-time snapshot  *Data is delayed at least 15 minutes
Global Business and Financial News, Stock Quotes, and Market Data and Analysis

© 2009 CNBC, Inc.  All Rights Reserved.
A Division of NBC Universal
Thomson ReutersThomson Reuters