The HPA is the sole manufacturer of ERWINASE® and the product is distributed on a world-wide basis by our partners EUSA Pharma. (http://www.eusapharma.com/erwinase.html)
ERWINASE® is indicated for the treatment of Acute Lymphoblastic Leukaemia (ALL), a type of cancer that particularly affects children. Erwinase® is an aparinginase enzyme that is used as part of the treatment protocols in conjunction with radiotherapy or chemotherapy. The product has been particularly successful over a number of years and survival rates without remission for this type of cancer are now high.
Asparagine is an amino acid that is essential for cell growth; it is produced by most but not all cells. Mutated cancer cells in ALL rely on asparagine circulating in the blood for growth. L-asparaginases are a group of enzymes that lower circulating asparagine levels in the blood, thereby depriving the mutated blood cells of asparagine and inhibiting their growth.
There are several different types of L-asparaginase available on the market, each derived from a different bacterium. Patients receiving treatment with L-asparaginase derived from Escherichia coli, who develop hypersensitivity to that form of the enzyme, may be able to continue treatment with ERWINASE® as the enzymes are immunologically distinct. Antibodies targeting E. coli derived L-Asparaginase have been shown not to cross-react with ERWINASE®.
The product is manufactured in the Agency's licensed pharmaceutical manufacturing facilities. Since its first registration in the UK in 1985 Erwinase® (Crisantaspase) has been registered in 22 countries and commercialised in more than 60 countries world wide, including approval in the US by the FDA in November 2011.
For more information about the Agency's manufacturing capabilities or the history of Erwinase manufacture please contact business@hpa.org.uk and for information about supply of the product please contact EUSA Pharma on Tel: +44 1438 735751, email: service-uk@eusapharma.com or see their website at www.eusapharma.com.