CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corporation (Nasdaq: GENZ) announced today that the European Commission has approved the production of Myozyme® (alglucosidase alfa) at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. The product will be made commercially available immediately. Myozyme is the only approved treatment for Pompe disease, a progressively debilitating and often fatal inherited disorder.
“This approval is important because it ensures that we can supply Myozyme to all patients in Europe who need treatment,” said Genzyme Senior Vice President Geoff McDonough. “We are grateful to all of the European authorities for their swift action on our application, and to the patients and physicians globally who helped us to conserve product supply over the past two months.”
During January and February, there was widespread adult patient compliance with the request to adjust infusion schedules to preserve product supply for infants and children. With this approval, the availability of product supply will now enable adult patients internationally to resume regular infusion schedules, and will allow new patients to initiate therapy. Sales are expected to accelerate starting in the second quarter and continue to increase throughout the second half of the year. Genzyme expects Myozyme sales for the first quarter of 2009 to be similar to the fourth quarter of 2008.
Myozyme is the only approved treatment for Pompe disease, a progressively debilitating disease that manifests as a broad spectrum of clinical symptoms. All patients typically experience progressive muscle weakness and breathing difficulty, but the rate of disease progression can vary widely depending on the age of onset and the extent of organ involvement. When symptoms appear within a few months of birth, babies frequently display a markedly enlarged heart and die within the first year of life. When symptoms appear during childhood, adolescence or adulthood, patients may experience steadily progressive debilitation and premature mortality due to respiratory failure. They often require mechanical ventilation to assist with breathing and wheelchairs to assist with mobility.
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. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.
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.
This press release contains forward-looking statements regarding Genzyme’s financial outlook and business plans and strategies, including without limitation: the anticipated impact of the 4000L manufacturing process on the supply of Myozyme and Genzyme’s ability to meet demand for the product internationally; the anticipated ability of patients to resume regular infusion schedules; expectations regarding the availability of Myozyme for new patients; expectations regarding Myozyme sales during the second quarter and second half of 2009; and projected sales of Myozyme for the first quarter of 2009. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: the actual timing of the transition of patients back to regular Myozyme infusion schedules; the actual timing of initiation of Myozyme treatment for newly identified patients; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the period ended September 30, 2008. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of today’s date and Genzyme undertakes no obligation to update or revise the statements.
Genzyme® and Myozyme® are registered trademarks of Genzyme Corporation or its subsidiaries. All rights reserved.
Lori Gorski, 617-768-9344
Patrick Flanigan, 617-768-6563