January 27, 2011
Fresenius Biotech announces agreement with Swedish Orphan Biovitrum for distribution of Removab®
Fresenius Biotech today announced a Removab® distribution agreement with Swedish Orphan Biovitrum (Sobi). Under the seven-year agreement, Sobi will distribute the trifunctional antibody Removab® exclusively in 15 European countries. The markets covered by the agreement include Bulgaria, the Czech Republic, Denmark, Estonia, Finland, Iceland, Latvia, Lithuania, Norway, Poland, Romania, Slovakia, Slovenia and Sweden. Removab® was granted marketing authorization by the European Commission in April 2009 for the treatment of malignant ascites associated with cancer and so far has been launched in Germany, Austria and France.
"The agreement with Sobi is part of our strategy to complement our own marketing and sales activities with strong partnerships in additional regions. More patients now will be able to benefit from Removab®," said Christian Schetter, CEO of Fresenius Biotech. "Removab® is an innovative product that holds great value for patients with severe medical needs. We are looking forward to the Fresenius Biotech partnership and the additional growth potential Removab® will provide for our business," said Kennet Rooth, CEO of Sobi.
About Removab® (catumaxomab)
Removab® is a trademark registered by Fresenius Biotech GmbH. It is the first drug worldwide with a regulatory label for the treatment of malignant ascites. Removab® is a trifunctional 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.
EU approval is based on results of a large-scale international phase II/III pivotal study which demonstrated a statistically significant fourfold 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. 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 tumor-associated antigen expressed on the vast majority of carcinomas (epithelial tumors). Furthermore, the majority of carcinoma-induced malignant ascites contain EpCAM-positive tumor cells. In healthy tissue, EpCAM is not accessible to binding, which makes it an attractive antigen for tumor-specific targeting.
About malignant ascites
Malignant ascites can be caused by various carcinomas. It is most common in ovarian, pancreatic and gastric cancers, with an incidence of 20 to 50 percent of all cases. Abdominal spread of cancer cells leads to an accumulation of fluid in the abdominal cavity and is associated with a poor prognosis. Malignant ascites develops late in the course of cancer disease and has a strong impact on the patient's quality of life. The most common treatment of malignant ascites is puncture (paracentesis), which must be performed 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. In 2009, group sales were approximately €14.2 billion. On Sept. 30, 2010, the Fresenius Group had 136,458 employees worldwide. For more information, visit the company's website at www.fresenius.com.
Fresenius Biotech, a company of the Fresenius health care group, is focused on the development, marketing and commercialization of biopharmaceuticals in the fields of oncology and transplantation medicine. Fresenius Biotech is a German company with headquarters in Munich. For more information, please visit www.fresenius-biotech.com.
Swedish Orphan Biovitrum (Sobi) is a Stockholm-based company with an international market presence and focused on providing and developing niche-specialty pharmaceuticals for rare-disease patients with severe medical needs. Focus areas are hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer and inherited disorders. For more information, please visit www.sobi.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Board of Management: Dr. Ulf M. Schneider (President and CEO), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Supervisory Board: Dr. Gerd Krick (Chairman)
Registered Office: Bad Homburg, Germany/Commercial Register No. HRB 10660