Genzyme’s preliminary revenues dip

By Nick Taylor

- Last updated on GMT

Related tags: Genzyme

Genzyme has reported a small dip in preliminary fourth quarter and full year revenues, driven by declining sales of Cerezyme and Fabrazyme which have been affected by manufacturing problems.

The preliminary results reflect the difficulties the biotech has experienced at its facility in Allston Landing, Massachusetts, US. Over the past 12 months the plant has faced a number of issues, leading to its temporary closure following the discovery that it was contaminated with a virus.

Disruption caused by these issues has resulted in shortage of some of Genzyme’s key products. Full year revenues for Cerezyme (imiglucerase) fell from $1.2bn (€828m) last financial year to $793m in the latest preliminary results.

Shipment of Cerezyme has now resumed and patients are expected to be able to resume normal dosing schedules in the first quarter of 2010. Fabrazyme (agalsidase beta) was also affected and its full year revenues fell from $494m to $431m.

The bulk of this dip occurred in the fourth quarter, with revenues falling from $126m in 2008 to $59m in the preliminary results, and production is currently at 70 per cent of demand.

Genzyme is working to resolve this, shipping newly produced Fabrazyme this week, and is expecting to meet 70 to 100 per cent of demand in the second quarter.

Strengthening manufacturing operations

To strengthen and expand its manufacturing operations Genzyme has implemented a two-year plan. This includes measures to improve overall quality systems and operational performance, increase product output and mitigate risks to protect supply at the Allston Landing site.

Currently Genzyme is transferring fill/finish operations from the Allston plant to its facility in Waterford, Ireland and to Hospira, a contract manufacturing organisation (CMO).

To accommodate long-term growth of the four transferred products Genzyme is expanding the fill/finish area at the Waterford site. In addition, it is adding a third 4000L bioreactor to its plant in Geel, Belgium and building a new facility in Framingham, Massachusetts, US.

Related topics: Contract Manufacturing & Logistics, QA/QC

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