Manufacturing Gaffes at Genzyme

May 14th, 2010 | Sources: BurrillReport, NY Times

Subjects:

Ongoing production problems at the factories of biotech giant Genzyme have caused massive disruptions in the lives of people with Gaucher disease and Fabry disease, a pair of rare, inherited conditions in which enzyme deficiencies allow fatty substances to build-up in the body and damage internal organs.

genzymeproductionfacilityThe factories produce Cerezyme, the enzyme used as replacement therapy for the 1,500 patients with Gaucher disease, and Fabrazyme, the enzyme used to treat about 1,000 patients with Fabry disease.

Genzyme’s production problems began nearly a year ago, after it discovered its main production facility had been contaminated by a virus.

Genzyme initially predicted the shortages would last 2 months, but subsequent glitches have impeded progress. At one point, some vials of the drugs were found to contain particles of fiber, rubber or steel.

The problems are particularly acute for Fabry patients, who can experience cardiac or kidney failure in the absence of drug replacement therapy. Fabry patients have been receiving about 30% of their normal doses during the crisis.

In Gaucher disease, which can cause anemia, bleeding and enlarged livers and spleens, severely affected patients have been receiving full doses of the drug, while others received nothing for months late last year.

“If most businesses run like this they’d be out of business,” one patient, Mark Malone told the New York Times. “Unfortunately, they have the drug we need.”

Henri Termeer, Genzyme’s CEO, acknowledged his company had let patients down. “We have to re-earn our standing with these patients,” he said.

Genzyme says it should be able to supply Cerezyme to all affected patients by May 1. Fabrazyme patients will have to wait until at least later this summer. Genzyme stock, which traded above $72 last year, now trades in the low 50s.

Genzyme booked a $175 million hit to its first quarter earnings in anticipation of a fine it expects the FDA to levy for the mess-up.


 

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