More woe for Genzyme as shipping delays continue
pharmafile | July 6, 2010 | News story | Manufacturing and Production |Â Â Cerezyme, Fabrazyme, Gaucher, Genzyme, manufacturing complianceÂ
Genzyme is expecting further delays in shipments of two key products as it struggles to bring its troubled Allston Landing manufacturing plant back up to speed.
Patients may experience shortages of Gaucher disease treatment Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) for Fabry disease, says the company in a filing to the Securities & Exchange Commission.
The additional delays have been caused by the lingering effects of power outages and water problems at the Allston Landing plant which were revealed in April, as well as changes to the manufacturing process for the two drugs which have been made in conjunction with the consent decree agreed with the US Food and Drug Administration (FDA) in May.
The company says it expects to ship around the same amount of Cerezyme in July as in the prior two months – which is around 50% of demand – with an increase in output in the following months.
For Fabrazyme output will remain pretty much as it is now – around 30% of demand – for the next three months. Supplies could also be affected by ongoing work to introduce a new working cell bank to boost productivity.
“From July through September many regions will see periods where Fabrazyme will be unavailable,” said Genzyme in the SEC statement.
Genzyme’s problems began when viral contamination forced a shutdown of the Allston Landing facility last year.
As the company worked to bring the plant back online, it was rocked by another contamination incident involving foreign particles – including rubber and stainless steel fragments – in cancer diagnostic Thyrogen (thyrotropin alfa) and another product, Aldurazyme (laronidase), used to treat mucopolysaccharidosis type I.
Genzyme’s troubles are a boost for UK-based rival Shire, which has been selling a competing product to Cerezyme – Vpriv (velaglucerase alfa) – since being granted US approval in February. The drug was also recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use last week.
Meanwhile, Shire’s Fabry disease drug Replagal (agalsidase alfa) is also benefitting from Genzyme’s supply problems, having been made available to Gaucher patients in the US since last December under an emergency access protocol ahead of full approval. The drug is also outselling Genzyme’s drug in Europe with around 60% of the market.
Phil Taylor
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