Genzyme expects FDA nod for new plant

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. 

- read the story in the Boston Globe
- check out the Wall Street Journal coverage