Genzyme inks expanded fill & finish deal with Hospira
In May Genzyme signed a consent decree with the US Food and Drug Administration (FDA). This said that Genzyme must move all fill and finish for products destined for the US out of its Allston, Massachusetts, US plant by November 29. Products sold in other regions have until August 2011.
Genzyme began moving production in January when it contracted Hospira and readied its own site in Ireland. Cerezyme (imiglucerase), Fabrazyme (agalsidase beta), Myozyme (alglucosidase alfa) and Thyrogen (thyrotropin alfa for injection) were subject to the move from the Allston site.
The companies have now replaced this deal with a new agreement that also covers Lumizyme (alglucosidase alfa), Thymoglobulin [anti-thymocyte globulin (rabbit)], Campath (alemtuzumab) and some developmental products.
Under the terms of the new deal Genzyme must purchase minimum quantities of products based on its forecasted supply requirements. Genzyme and Hospira will agree a statement of work (SOW) for each product detailing service fees, specifications and manufacturing information.
The agreement is due to finish on whichever is later, June 30 2015 or the end of the last SOW. Unless either party provides at least 24 months written notice of termination the deal will be automatically renewed for one year.
EMA and the Fabrazyme shortage
Earlier this week the European Medicines Agency (EMA) said it expects Fabrazyme shortages to continue until the end of the year. Consequently it is recommending that no new patients start taking Fabrazyme unless there is no other option.
For patients that require a small dose of Fabrazyme the EMA is recommending doctors consider changing their prescription to Shire’s Replagal (agalsidase alfa). Genzyme’s share price dropped after news of the EMA recommendation but recovered after details of the Hospira deal emerged.