Shares of Genzyme (GENZ) are up $2.83, or almost 6%, at $51.34, after the company last night confirmed details of $175 million settlement with the Food & Drug Administration on issues surrounding its drug manufacture, and said this morning the FDA had approved its drug to treat Pompe disease.
Last night’s agreement with the FDA follows the general outlines of Genzyme’s announcement last month that it expected to take a $175 million charge in the quarter to pay disgorgement of past profits deriving from production of its Cerezyme and Myozyme drugs, after the FDA slapped the company with a consent decree back in March.
Meantime, the company’s “Lumizyme” was approved for patients 8 and older in the U.S. for treatment of Pompe, a heritable disease, potentially fatal, marked by an excess of glycogen.
Genzyme said it’s been working on Lumizyme for a decade and spent $1 billion developing it.
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