Healthcare Industry News: Pompe disease
News Release - July 24, 2006
Genzyme Receives Approval for Additional Manufacturing at Ireland PlantThymoglobulin Fill/Finishing to Begin Immediately; Other Products Expected to Soon Follow
CAMBRIDGE, Mass., July 24 (HSMN NewsFeed) -- Genzyme Corporation (Nasdaq: GENZ ) announced today that the U.S. Food and Drug Administration has approved the fill/finishing, packaging and labeling of Thymoglobulin® (anti-thymocyte globulin, rabbit) at its state-of-the-art Waterford, Ireland facility. The approval allows Genzyme to begin manufacturing and distribution of Thymoglobulin, a product for the treatment of acute rejection in patients with a kidney transplant, from this single location and further enhances Genzyme's manufacturing efficiencies.
"We are very pleased with this approval, as it continues the development of our supply strategy with Waterford serving as our major European production and distribution center for large volume runs of a broad range of products," stated Mark R. Bamforth, Genzyme's senior vice president for corporate operations and pharmaceuticals. "We look forward to also receiving similar fill/finish approvals for two of our enzyme replacement therapies at Waterford in the coming months."
Genzyme is currently conducting approval-qualifying manufacturing runs of Cerezyme® (imiglucerase for injection) and Myozyme® (alglucosidase alfa) at the facility. Myozyme was approved this year in Europe and the U.S. for treatment of Pompe disease -- a debilitating, progressive and often fatal disorder affecting fewer than 10,000 people worldwide. Genzyme currently manufactures Myozyme in the United States. The company expects to also scale-up bulk production of Myozyme at its new protein manufacturing facility in Geel, Belgium, and then fill and package the product in Waterford to ensure that it is able to meet the anticipated demand for Myozyme throughout the world. Genzyme currently produces Cerezyme at its flagship manufacturing facility in Allston, MA. The company plans to use the Waterford facility for additional capacity and security for Cerezyme's fill/finish.
When Genzyme completed a major expansion at Waterford last year, it added high-quality biological filling and packaging capabilities to support the growth of protein products such as Myozyme and Cerezyme, along with products like Thymoglobulin that are manufactured at other Genzyme facilities. The facility uses a state-of-the-art isolator system that provides the reliability of a sterile environment and the assurance of producing quality products.
Waterford is already the primary tableting and bottling center for Renagel® (sevelamer hydrochloride). In 2005, the plant produced approximately 3 million bottles of Renagel for patients with chronic kidney disease who are on dialysis.
A Strong Global Infrastructure
Genzyme has substantially strengthened its global infrastructure for manufacturing and product development through four major recent expansion projects in Belgium, Ireland, and the United Kingdom. The expanded facilities officially opened last year and are supporting Genzyme's continued growth and innovation, particularly in the areas of antibody and protein-based medicines.
In addition to Waterford and Geel, the facilities include expansion of a manufacturing center in Haverhill, UK and the creation of an antibody discovery research facility in Cambridge, UK.
Genzyme has a total of seven manufacturing sites in Europe, including a small molecule production site in Liestal, Switzerland, a polyclonal bio-manufacturing site in Lyon, France, and diagnostic manufacturing facilities in Kent, UK and Russelsheim, Germany.
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. This year marks the 25th anniversary of Genzyme's founding. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 8,000 employees in locations spanning the globe and 2005 revenues of $2.7 billion. Genzyme has been selected by FORTUNE as one of the "100 Best Companies to Work for" in the United States.
With many established products and services helping patients in more than 80 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 diseases, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as heart disease and other areas of unmet medical need.
This press release contains forward-looking statements, including without limitation statements about: intended manufacturing and other uses for Genzyme's manufacturing facilities and the anticipated timing thereof, including the use of the Waterford, Ireland facility for Cerezyme and Myozyme and the production of Myozyme at Genzyme's facility in Geel, Belgium; the estimated Pompe disease patient population; the expected receipt of regulatory approvals to manufacture and/or fill/finish Myozyme and Cerezyme in the Waterford facility and the expected timing thereof; the anticipated ability to meet demand for Myozyme; and the anticipated growth of antibody and protein- based products. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: the timing and results of manufacturing runs at the Waterford facility that are intended to be used to receive regulatory approvals; the ability to obtain regulatory and other approvals, including any and all regulatory approvals required for the planned uses of the Waterford and Geel facilities, and the actual timing thereof; the accuracy of the company's information about the Pompe disease patient population; Genzyme's ability to manufacture products in a timely and cost effective manner; and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including the factors discussed under the caption "Factors Affecting Future Operating Results" in Genzyme's Quarterly Report on Form 10-Q for the quarter ended March 31, 2006. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise these statements.
Genzyme®, Thymoglobulin®, Cerezyme®, Myozyme® and Renagel® are trademarks of Genzyme Corporation or its subsidiaries. All rights reserved.
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