CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corporation (Nasdaq: GENZ) announced today that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company’s variation to produce Myozyme® (alglucosidase alfa) at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. The positive CHMP opinion is the final step before formal approval to produce and market Myozyme manufactured at the 4000 L bioreactor scale in the European Union, Norway and Iceland.
The CHMP acted quickly on the application due to the current constraints on supply. The 4000 L manufacturing process is expected to help provide adequate supply of Myozyme in Europe for the foreseeable future.
The committee's opinion will be forwarded to the European Commission, which will make a final decision on the authorization. The Commission has 44 calendar days to act on the CHMP’s opinion. The European Commission generally follows the advice of the CHMP, but it is not obliged to do so.
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 expected receipt of regulatory approval for Myozyme produced at the 4000 L scale in the EU and the anticipated timing thereof; and the anticipated impact of the 4000 L manufacturing process on the supply of Myozyme and Genzyme’s ability to meet demand for the product in Europe; 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: whether the European Commission approves Myozyme manufactured at the 4000 L scale and the actual timing of the European Commission’s decision; 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. All rights reserved.
for Genzyme Corporation
Lori Gorski, 617-768-9344
Patrick Flanigan, 617-768-6563