Quality-control issue disrupts Fabrazyme flow

A quality-control problem at Genzyme has disrupted shipments of Fabrazyme, the treatment for Fabry's disease that's already running short. The company says August supplies have been delayed, and that it's notifying patients about the problem. As Pharmalot reports, some patients aren't happy because they just received a supply update saying the month's supplies would be as usual.

Under normal circumstances, Genzyme might have been able to keep the drug coming despite a manufacturing hiccup, but these aren't normal circumstances. Supplies of Fabrazyme have not come back to normal levels since Genzyme had to shut down a Boston-area plant because of viral contamination. "Since we are operating without inventory, this delay will disrupt our shipping schedule, which is why we began calling affected patients," a Genzyme spokesperson told Pharmalot.

Fabrazyme has been subject to a rationing program since that plant shutdown, and supplies have been disrupted further because of manufacturing problems. Now owned by Sanofi, the company has been promising to return to normal supply levels during the second half of this year, when production could be moved to a new manufacturing facility in Framingham, MA.

However, Sanofi announced last week that Genzyme's production isn't likely to meet goals set to qualify for a milestone payment to ex-Genzyme shareholders. And the new target for providing Fabrazyme made in Framingham is the first quarter of 2012, provided the plant gets regulatory approval as expected.

- read the Pharmalot piece
- get the update from Sanofi

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