When Cambridge, MA-based Genzyme (NASDAQ: GENZ) shut down its Allston, MA, bioreactor plant in June after discovering viral contamination, it was clear that there would be worldwide shortages of its best-selling enzyme replacement therapies, agalsidase beta (Fabrazyme) and imiglucerase (Cerezyme), and that there would be a hit to the company’s bottom line. The company got more specific about those matters today, saying in a press release that it’s taking longer than expected to restore full production of agalsidase beta, and that sales of both drugs this year will be below previously anticipated levels.
Revenue from agalsidase beta, a treatment for Fabry disease, is expected to be roughly $450 million in 2009, about $60 to $70 million less than the company had predicted in previous guidance. Revenue from the Gaucher disease treatment imiglucerase is expected to reach $800 million, which is at the low end of the previously predicted range of $750 million to $1 billion. Genzyme’s stock price was roughly flat this morning.
After sanitizing the Allston plant, Genzyme resumed production of both drugs in July, and it said today that it expects to begin shipping newly produced batches of the Gaucher drug in November, as planned.
But the news for Fabry disease patients is not as encouraging. New shipments of agalsidase beta won’t go out until mid-December, the company says, and there will be less of it to go around than previously thought. The problems: Genzyme took some extra time to do preventive maintenance before restarting the bioreactors that make agalsidase beta; the vessels are now producing the drug in lower quantities than in the past, for reasons the company isn’t disclosing; and the company has been making the drug in smaller batches, which is faster but less efficient.
As a result, “additional product conservation measures are now needed to help ensure that the limited remaining Fabrazyme inventory can be made available to as many patients as possible until new material is available,” the company said in today’s announcement. Specifically, the company said that from October 1 through the end of the year, it will only ship enough agalsidase beta to meet 30 percent of global demand; up to now, the company said it had enough of the drug on hand to cover about 80 percent of demand.
Genzyme says it’s working with doctors to set up clinical guidelines for conserving doses of the drug. The company expects to work its way back to full production—covering 100 percent of demand—sometime in the first quarter of 2010.
“We will continue to work with all stakeholders to prepare for the release of this material so that it can reach patients as quickly as possible,” Genzyme chairman and CEO Henri Termeer said in today’s announcement. “I want to express my deep appreciation to the Gaucher and Fabry communities for their support of the existing product conservation guidelines and for their anticipated collaboration in helping to manage the remaining limited product supply through the end of this year.”