Trifunctional antibody was approved by EC in 2009 and is currently marketed in Austria and Germany.
Swedish Orphan Biovitrum (SOBI) will distribute Fresenius Biotech’s EU-approved Removab® (catumaxomab) antibody treatment for cancer-related malignant ascites in 15 Europe countries. The seven-year agreement covers Sweden, Denmark, Norway, Finland, Iceland, Poland, the Czech Republic, Slovakia, Slovenia, Romania, Bulgaria, Hungary, Estonia, and Lithuania.
Removab was cleared for marketing by the European Commission in September 2009, and to date has only been launched in Austria and Germany. EU approval covers its use for the treatment of malignant ascites in patients with EpCAM-positive cancers for whom standard therapy is either not ailable or no longer feasible. “Removab is a perfect fit with our cancer product portfolio such as Yondelis®, which is distributed in similar territories,” comments Kennet Rooth, SOBI CEO. “We are looking forward to the Fresenius Biotech partnership and the additional growth potential Removab will add to our business.”
Removab is a trifunctional antibody licensed by Fresenius from Trion Pharma. It is designed to bind to three different cell types simultaneously. One arm of the antibody recognizes and binds to T cells, and the other arm binds EpCAM expressed by a range of cancers. In addition, immune effector cells with Fc receptors also bind to the Fc region of Removab. Fresenius claims this three-way binding results in the co-stimulation and activation of T cells and accessory cells, enabling the generation of a strong immune response against cancer cells.