't zal maar gebeuren schreef op 22 maart 2018 13:43:
HAE product sales for the year ended
December 31, 2017 increased to $1,429.6
million or 9% from $1,310.9 million in 2016,
primarily driven by FIRAZYR, up 15% to
$663.0 and CINRYZE up 3% to $699.3
million. During the third quarter of 2017,
CINRYZE had a supply constraint caused
by a manufacturing interruption at a
third-party supplier. The issue was
addressed and production resumed in
the fourth quarter of 2017. On January 24,
2018, FDA granted approval for the
technology transfer of CINRYZE drug
product manufacturing process to the
Vienna, Austria manufacturing site.
The Company expects to start
manufacturing CINRYZE drug product
in-house in Vienna in the first quarter of
2018, providing an additional supply
source to meet patient demand