EPO CASE STUDY

Product case study: Neorecormon

Neorecormon (tradename, also known as epoetin beta) is a recombinant human EPO first approved
for medical use in the EU in 1997.

It is indicated for the treatment of anaemia associated with various medical conditions, most
commonly chronic renal failure and cancer patients receiving chemotherapy.

Neorecormon is produced by recombinant DNA technology in a CHO cell line and is manufactured as
outlined in Figure below. It is presented in lyophilized format at various strengths (500–10 000
IU/vial) and contains phosphate buffer, sodium chloride, calcium chloride, urea, polysorbate and
various amino acids as excipients.

The product displays a terminal half-life of 4–12 h and 8–22 h after i.v. and s.c. administration
respectively. Dosage regime is dependent upon the exact disease condition, but generally involves
administration once/several times weekly. Various clinical trials investigating various indications
proved product efficacy in the treatment and prevention of anaemia, with increased haemocrit
values observed.

Common side effects include increased blood pressure, increased respiratory infections and
increased platelet counts. Serious (rare) side effects were most often related to cardiovascular
complications. Neorecormon is marketed by Roche.