Genzyme's Lumizyme BLA Receives Six-Month FDA Review
PDUFA Date Set For June 17, 2010
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corporation (Nasdaq: GENZ) announced today that it has received a June 17, 2010 PDUFA date from the FDA for its Biologics License Application for LumizymeTM (alglucosidase alfa) seeking approval for the therapy produced at the 4000 L scale. The FDA has classified the resubmission as a class 2 complete response, which carries a six-month review timeframe.
Genzyme last month reopened enrollment in the Alglucosidase Alfa Temporary Access Program (ATAP), a program which provides access to treatment for severely affected adults with Pompe disease prior to commercial approval of Lumizyme. The company has provided therapy free of charge to approximately 170 patients since 2007, and is working with the 81 active study sites in the U.S. to enroll additional patients into this program. The ATAP program will remain open until commercial approval of Lumizyme. The 4000 L-scale Lumizyme is produced at Genzyme's manufacturing plant in Geel, Belgium.
Lumizyme is marketed outside of the United States as Myozyme® (alglucosidase alfa). Myozyme is commercially approved for the treatment of Pompe disease in approximately 40 countries worldwide.
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 12,000 employees in locations spanning the globe and 2009 revenues of approximately $4.5 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.
This press release contains forward looking statements regarding Genzyme's future business plans and strategies, including: the potential receipt of FDA approval of Lumizyme produced at the 4000 L bioreactor scale; the expected timing of the FDA review and action on the Biologics License Application for Lumizyme; and the expectation that the ATAP program will remain open until commercial approval of Lumizyme. These forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those forecasted. These risks and uncertainties include: that Genzyme is unable to obtain FDA approval for Lumizyme produced the 4000L scale for any reason; that Genzyme does not receive a decision from the FDA regarding the BLA for Lumizyme during the anticipated timeframe; that Genzyme has not forecasted anticipated product demand accurately; that Genzyme is unable to manufacture product in sufficient quantities of product to meet demand; 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 without limitation the information under the heading "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the quarter ending September 30, 2009. 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® and Myozyme® are registered trademarks, and LumizymeTM is a trademark, of Genzyme Corporation or its subsidiaries. All rights reserved.
Lori Gorski, 617-768-9344
Patrick Flanigan, 617-768-6563