The effects of power cuts and water problems at Genzyme’s Allston Landing manufacturing plant is expected to cause further delays to the shipment of two of the company’s key products, it has emerged.
Genzyme said patients may experience shortages of Cerezyme (imiglucerase), which treats Gaucher disease, and Fabrazyme (agalsidase beta) for Fabry disease in a submission to the Securities & Exchange Commission (SEC).
In addition to the effects of the power cuts and water problems at the plant, delays have been caused by changes in the manufacturing process for the drugs, which are made with the consent decree agreed with the US Food and Drug Administration (FDA).
Genzyme forecasts it will ship enough Cerezyme in July to satisfy about 50% of demand, the same levels as in the previous two months, with output increasing in the following months. Fabrazyme output is expected to continue to meet 30% of demand for the next three months and supplies could be affected by efforts to introduce a new working cell bank to increase productivity.
In the statement to the SEC, Genzyme said: “From July through September many regions will see periods where Fabrazyme will be unavailable.”
Copyright Press Association 2010