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Genzyme rare disease drugs in short supply

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Genzyme is scrambling to increase production--but apparently can't scramble fast enough. The company announced that its supplies of drugs for rare diseases will continue to fall short of demand, and that its limited inventory could cause shipping delays.

It's the supply of Fabrazyme, Genzyme's Fabry disease treatment, that are most problematic. Right now, Fabrazyme production is running at 30 percent of demand and will stay that way for the next three months, the company said. It's been trying to boost production, but hasn't been meeting its targets, Reuters reports, so through September, the drug will be unavailable in many regions.

Genzyme said in an SEC filing that it's turning out enough Cerezyme, its drug for Gaucher disease, to meet 50 percent of demand. That level will increase after July, but the company didn't say how much. Its ability to produce more of the drug depends on a.) fixing production disruptions because of problems with its water system; and b.) implementing an FDA consent decree.

Genzyme agreed to operate under the consent decree after its key Boston plant was shut down because of viral contamination. The company has struggled to fix its manufacturing problems, but lack of production touched off shortages of its drugs, allowing at least one competitor to leap into the market.

- read the Reuters piece
- check out the news from PharmaTimes

Related Articles:
Genzyme ready for FDA consent decree drill
Genzyme paying big for GMP slips
Genzyme patients disillusioned by production snafus


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