The Massachusetts drugmaker announced its plan this week, after renegotiating terms with its current supplier, Sanquin Blood Supply, which has produced the drug - a C1 esterase inhibitor – under an exclusive deal signed with ViroPharma.
A Shire spokeswoman told us “Sanquin will be among other manufacturers for CINRYZE. We are actively working with a number of partners to evaluate all options to increase Cinryze supply, as a course of future business planning.”
Cinryze is derived from human plasma – sourced exclusively from the US – and is produced using a series of precipitation, filtration and chromatography steps. Prior to the expansion Sanquin was the only supplier to be making it on Shire’s behalf.
Under the terms of the revised deal, in addition to being able to seek additional suppliers, Shire also has access to the filtration and processing technologies Sanquin uses to produce Cinryze.
But despite this access, Shire is unlikely to bring Cinryze manufacturing in house according to the spokeswoman.
“Given the nature of the product we would not consider manufacturing a blood plasma product in our current cell culture manufacturing plants, to avoid potential cross contamination issues.”
Cinryze is used to treat Hereditary Angioedema (HAE), which is a rare inherited blood disorder that causes episodic attacks of swelling that affect the face, extremities, genitals, gastrointestinal tract and upper airways.
The drug generated revenue of $503m (€445m) in 2014. Shire’s other HAE medication Firazyr brought in sales of $364m last year.