Swedish Orphan Biovitrum announced a Removab distribution agreement with Fresenius Biotech. Under the agreement Swedish Orphan Biovitrum (Sobi) will distribute Removab exclusively in 15 European countries over 7 years.

Removab was granted marketing authorization by the European Commission in April 2009 for the treatment of malignant ascites associated with cancer and has been launched in Germany and Austria so far. The territories in which Sobi will distribute Removab are Sweden, Denmark, Norway, Finland, Iceland, Poland, Czech Republic, Slovakia, Slovenia, Romania, Bulgaria, Hungary, Estonia, Latvia and Lithuania.

“Removab is an innovative product that holds great value to patients with high medical needs. We are looking forward to the Fresenius Biotech partnership and the additional growth potential Removab will add to our business. Moreover, Removab is a perfect fit with our cancer product portfolio such as Yondelis which is distributed in similar territories,” said Kennet Rooth, CEO of Sobi.

“The agreement with SOBI is part of our strategy of complementing our own marketing and sales activities with strong partnerships in additional territories. We appreciate that more patients are now able to benefit from Removab,” said Christian Schetter, CEO of Fresenius Biotech.

Removab is a registered trade mark by Fresenius Biotech GmbH. It is the first drug worldwide with a regulatory label for the treatment of malignant ascites. Removab is a tri-functional antibody licensed from Trion Pharma GmbH. The therapeutic objective of Removab is to generate a strong immune reaction against cancer cells resulting in their elimination.

The EU approval is based on the results of a large international phase II/III pivotal study which demonstrated a statistically significant four-fold increase in puncture-free survival over a therapy with puncture alone. Removab effectively destroys cancer cells in the peritoneal cavity and therefore attacks the primary cause of ascites formation. This leads to a prolongation to the time to next paracentesis, a reduction of the number of painful and burdensome punctures and an improvement of the patients' quality of life and daily function. In addition, the results of the study indicate a positive impact on overall survival.

Removab is approved for the treatment of malignant ascites in patients with EpCAM (Epithelial Cell Adhesion Molecule) positive carcinomas where standard therapy is not available or no longer feasible.

EpCAM is a tumour-associated antigen expressed on the vast majority of carcinomas (epithelial tumours). Furthermore, the vast majority of carcinoma-induced malignant ascites contain EpCAM positive tumour cells. In healthy tissue, EpCAM is not accessible to binding, which makes it an attractive antigen for tumour specific targeting.

Malignant ascites is the accumulation of fluid in the abdominal cavity mainly due to abdominal spread of cancer cells and it is associated with a poor prognosis. Malignant ascites can be caused by different carcinomas. It is most common in ovarian, pancreatic and gastric cancers with an incidence of 20 to 50% of all cases.

Malignant ascites develops late in the course of the cancer disease and regularly has a strong impact on the patient's quality of life. The most commonly used treatment of malignant ascites is puncture (paracentesis), which has to be carried out repeatedly and can lead to complications such as infection and fluid or protein deprivation.

Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. Fresenius Biotech is focused on the development, marketing and commercialization of biopharmaceuticals in the fields of oncology and transplantation medicine.

Swedish Orphan Biovitrum (Sobi) is a Swedish based niche specialty pharmaceutical company with an international market presence and is focused on haemophilia, inflammation/autoimmune diseases, fat mal-absorption, cancer and inherited metabolic disorders.