All six bioreactors at Genzyme's (GENZ) troubled Allston plant are fully operational, the company says. Production of the Gaucher disease drug Cerezyme is on track, with four bioreactors producing bulk material. The company anticipates that newly produced Cerezyme will be available for shipment beginning in November.
The first shipments of Fabrazyme, for Fabry disease, are now expected in mid-December, the company says. But finished-product volumes will be lower than expected. Fabrazyme bioreactors were re-started later than planned due to maintenance and sanitization procedures in the decontamination of the facility, which suffered Vesivirus 2117 contamination in May, followed by facility shut-down.
To speed Fabrazyme production, Genzyme says it has been processing bulk material in smaller-than-usual batches. Such processing, however, leads to losses in process efficiency and lower overall volume. So the company advises that existing supplies be further stretched.
The shut-down and delays are taking a toll: Genzyme says it now expects 2009 Cerezyme revenue of approximately $800 million, compared with previous guidance that forecasted revenue at the lower end of a $750 million to $1 billion range. Fabrazyme revenue is expected to be approximately $450 million in 2009, compared with previous guidance of $510 to $520 million.
- here's the announcement