FDA flexes muscles over ailing Genzyme plant
pharmafile | March 29, 2010 | News story | Manufacturing and Production |Â Â Cerezyme, Fabrazyme, Gaucher, Genzyme, manufacturing complianceÂ
Manufacturing compliance problems continue to weigh down US biotechnology company Genzyme, with the US Food and Drug Administration now saying it is considering “enforcement action” at the firm’s troubled Allston Landing plant.
That enforcement action will probably take the form of a consent decree – in which the company is set a deadline for resolving problems and the risk of hefty fines if it fails to do so – and the appointment of third-party inspectors.
Genzyme has not yet disclosed details but said the process would likely involve a protracted inspection period and payments to the government.
The company has been hit hard by a string of contamination issues that have hit at its ability to supply some of its top-selling products, including Cerezyme (imiglucerase) for Gaucher disease and Fabrazyme (agalsidase beta) for Fabry disease.
Viral contamination forced a shutdown of the Allston Landing facility last year, and as the company worked to bring the plant back online it reported 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.
Shares in the company yo-yoed last week after investors reacted to the news and then bought back into the company on speculation that the situation could set Genzyme up for a takeover bid.
Meanwhile, Genzyme chairman Henri Termeer said the biotech firm is “advancing the recovery of the Allston plant”.
The company has already hired a new president of global manufacturing (Scott Canute) and vice president of global product quality (Ron Branning) to oversee its manufacturing recovery and has appointed external consultants to assist in the process. It said it would also name a new site head.
The firm added that based on initial discussions with the FDA it expects to be able to continue to supply Cerezyme and Fabrazyme made at the Allston Landing facility to patients.
Other products that are filled and finished at the plant – namely Myozyme (alglucosidase alfa) for Pompe disease, made at the 160-litre scale, and Thyrogen – are also expected to continue shipping to avoid interruption in supply, it said.
Related Content
Read the July/August edition of Pharmafocus online now!
The latest monthly edition of Pharmafocus, the July/August issue, is available to read for free …
Use of Genzyme’s MS drug Lemtrada restricted under ongoing EMA safety review
The EMA has launched a review into Genzyme’s multiple sclerosis drug Lemtrada (alemtuzumab) after reports …
Alnylam and Sanofi close research phase of 2014’s $700m RNAi rare disease partnership
Alnylam and Sanofi have announced their intention to bring to an end the research and …
