Genzyme says it has polished its manufacturing act. The company is poised to boost production of its costly treatment for Pompe disease, provided FDA finally gives its blessing to a new production facility in Framingham, MA. Genzyme, of course, hopes the agency will do so soon--by the end of the month, it says--so it can turn out more of its key product.
If the nod comes, it will follow more than a year of tinkering at its new bio-reactor facility and dickering with the FDA bureaucracy. As you may recall, the agency said the new facility's output wasn't bio-identical to the Myozyme turned out at Genzyme's smaller plant. So Genzyme had to apply for a license for the new reactor's product and agree to market it under a different name, Lumizyme.
Whatever the name, the drug is Genzyme's fastest-growing and thus key to its fortunes. Its fourth-quarter profits grew 9.8 percent on the strength of higher sales of Myozyme, which runs about $300,000 per year. With the new facility, Genzyme can boost sales by as much as 49 percent this year to $440 million, the company says.