Fresenius receives Orphan Drug Designation for antibody removab® to treat patients with ovarian cancer

Fresenius today announced that it has received Orphan Drug Designation from the European Commission for the trifunctional antibody removab® to treat patients with ovarian cancer. The Orphan Drug Designation entitles Fresenius to up to 10 years market exclusivity in the EU for removab® for the treatment of ovarian cancer upon marketing approval.

Fresenius in September 2003 successfully completed a phase I/II study using the trifunctional antibody removab® for the treatment of malignant ascites in ovarian cancer. The antibody proved to be well-tolerated and demonstrated first significant effects regarding tumor cell reduction.

Based on the encouraging results of the phase I/II study, a clinical phase Ila study for the treatment of ovarian cancer should begin shortly. The primary objective of this study is to determine an optimized dosing as well as to further examine its efficacy. The final report is expected by the end of 2005.


Background information

Orphan Drug
"Orphan Drugs" are medicinal products used for rare, life-threatening diseases or chronically debilitating condition where no other or no sufficient effective treatment exists. Additional benefits include regulatory assistance as well as advice on the conduct of clinical trials from the EMEA (European Agency for the Evaluation of Medicinal Products).

Fresenius Biotech
Fresenius Biotech GmbH is a company of the Fresenius Group, focused on the development and marketing of biopharmaceuticals in the fields of oncology, immunology and regenerative medicine.

Fresenius
Fresenius is a global health care group providing products and services for dialysis, the hospital and the medical care of patients at home. In 2003 Group sales amounted to € 7.1 billion. Fresenius had 66,264 employees worldwide on December 31, 2003