Genzyme confirms further Fabrazyme delay
pharmafile | September 13, 2011 | News story | Manufacturing and Production |Â Â Fabrazyme, Genzyme, pharma manufacturing newsÂ
Genzyme has been forced to delay shipments of its Fabry disease treatment Fabrazyme once again, blaming its “quality release process”.
The US company – which has been part of French pharma company Sanofi since April – apologised to patients for the continued delay in getting supplies back on track for the drug.
Fabrazyme (agalsidase beta) has been strictly rationed since its Allston Landing facility was hit by viral contamination and other quality control problems in 2009.
Towards the end of July, Genzyme had sent a letter to patients saying it planned to deliver another shipment of Fabrazyme on 1 August, but had to backtrack on that commitment because the quality issue prevented it being released.
“Because we have a very limited inventory of Fabrazyme, we rely on each release of Fabrazyme in order to have enough medication to ship each monthly allocation,” said the company in a new letter to patients published on the FDA’s website.
Despite the delay, Genzyme does hope to provide the scheduled August allocation of 1mg/kg to individuals currently on treatment with Fabrazyme, although not until later this month. The timing of the September allocation will be decided in the coming weeks.
Supplies of another of Genzyme’s products which was affected by the Allston Landing problems – Gaucher disease treatment Cerezyme (imiglucerase) – are now back on track.
The company does not anticipate being able to restore normal service for Fabrazyme however until a new manufacturing facility in Framingham, Massachusetts, is cleared by the FDA.
In July it said it expected that go-ahead in the second half of 2011, and that Fabrazyme made there would be ready to ship to patients in the first quarter of 2012.
Regardless, Genzyme now believes that it will need the production capacity of both Framingham and Allston Landing in order to achieve a sustainable increase in supply.
Thyrogen update
Manufacturing problems have also impacted Genzyme’s ability to supply Thyrogen (thyrotropin alfa) for thyroid cancer, and the company said on 12 September it will only be able to meet 40-60% of global demand throughout the remainder of 2011.
The company believes that Thyrogen supply constraints will occur throughout 2012 as well.
Phil Taylor
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