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Genzyme Corp. plans to build a manufacturing plant in Geel, Belgium, to aid growing production of its Pompe disease drugs, Lumizyme (known outside the U.S. as Myozyme), the company announced in a news release today.
The plant, which will cost about €250 million or about $337 million, is expected to be approved for commercial use late in 2014. Genzyme (Nasdaq: GENZ) officials noted that the plant will have 8,000-liter production capacity, room to expand, and purification installation.
Genzyme’s existing production plant for the drug, which is increasing capacity to 12,000 liters, is located in Geel next to the new construction area. The newly constructed plant will support 150 new jobs.
Pompe disease is a deficiency of a certain enzyme that helps the body break down glycogen, a complex carbohydrate that is converted to glucose for energy. Without the enzyme, glycogen builds up in the heart and other muscles.
Lumizyme and Myozyme are both used to treat Pompe disease. Myozyme, used by all ages outside the U.S. and for infants only in the U.S., is produced in both large and small batches; It received U.S. FDA approval in 2006 to treat the neuromuscular disease. Lumizyme, on the other hand, is produced in large batches in the U.S. and is used in the U.S. only for adults and children over eight years old. Lumizyme was approved by the U.S. Food and Drug Administration in May 2010, after two failed attempts for approval. The FDA’s initial rejection of Lumizyme came before Genzyme's Allston plant shut down temporarily and noted the need for an agreed-upon post-approval verification study and a finalized Risk Evaluation and Mitigation Strategy. Its second rejection was related to problems with the Allston-based manufacturing plant that produced it. The Allston plant shut down temporarily in June 2009 after the company detected a virus that impairs cell growth in one of the site’s six bioreactors.
Editor's Note: Article updated to clarify the different uses and production of Lumizyme and Myozyme.
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