Manufacturing woes hit Genzyme results
pharmafile | July 22, 2010 | News story | | 2010 financials, Genzyme, Q2
Genzyme has posted a decrease in sales for the second quarter as its manufacturing woes continue.
The US-based biopharma company saw sales decrease by 11% to $1.08 billion, primarily due to the fall off in revenue contribution from its two key products.
Gaucher treatment Cerezyme, its biggest seller, has seen sales drop by over half to $139,000 and Fabrazyme, indicated for Fabry disease, fell by 71% to $39,500.
There were better results for Genzyme’s Pompe disease treatment Myozyme and Aldurazyme for MPS I management, sales of which increased by 16% and 11% respectively.
Henri Termeer, Genzyme’s chairman and chief executive, said: “This was a difficult quarter as reflected in our financial results, but based on the progress we’ve made with our recovery efforts, the outlook for the second half of 2010 is promising.
“We are encouraged by the improvements in Cerezyme and Fabrazyme manufacturing. We expect that increasing sales of these products combined with reductions in our operating costs will produce an increase in earnings during the second half of the year.”
The shortages of Fabrazyme and Cerezyme have resulted from quality defects in products made at its Allston Landing facility in the US. These include a viral contamination issue and the company is struggling to get its production back to capacity.
Genzyme said in a statement that its Allston facility remains “fully operational and will begin increasing shipments of Cerezyme in August”. The company expects that patients will be able to begin increasing their doses in September and return to normal dosing in the fourth quarter.
As part of this the company recently signed an agreement with specialist delivery pharma company Hospira for fill/finish manufacturing services for some of Genzyme’s products, including Fabrazyme.
Genzyme also said that it was continuing its efforts to improve the productivity of the Fabrazyme manufacturing process, and has received both FDA and EMA approval to use the new working cell bank, with shipments of Fabrazyme expected to increase in the fourth quarter.
At the company’s new Framingham manufacturing facility, two bioreactors are currently operational and Fabrazyme engineering runs are planned for September. The company said that the facility was on-track for approval, anticipated in late 2011.
Meanwhile, the firm’s problems were compounded by the EMA’s decision earlier in July to recommend Shire’s Replagal ahead of Fabrazyme because of continued shortages of Genzyme’s medicine.
Ben Adams
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