European Authorities Approve Larger-Scale Production of Genzyme's Myozyme
Genzyme Corporation (Nasdaq: GENZ) announced 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.
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. 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.
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