April 23, 2009 – Munich, Germany – TRION Pharma GmbH today announces that the European Commission has approved its trifunctional antibody Removab® (catumaxomab) for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas. The Marketing Authorisation Application was filed by TRION’s partner Fresenius Biotech in December 2007. Removab® will be marketed by Fresenius Biotech and produced by TRION Pharma, the inventor of the compound and the underlying Triomab® technology.
Removab® is worldwide
1. The first approved treatment of malignant ascites
2. The only approved antibody targeting EpCAM, an antigen expressed on almost all carcinomas
3. The first approved bispecific, trifunctional antibody
4. The first approved therapeutic antibody invented, developed and produced in Germany
“It has been a long-standing vision of physicians and scientists to create a bispecific antibody that would be able to direct T cells, the body’s most potent immune effector cells, against cancer. Removab® is the first approved antibody to achieve this goal,” said Horst Lindhofer, CEO of TRION Pharma.
Traditional, monospecific antibodies can only recruit effector cells from the innate immune defense. TRION’s bispecific, trifunctional Triomab® antibodies, however, additionally bind and activate the particularly potent group of killer T cells. As a result, they destroy tumor cells at least 1,000fold more effectively than conventional antibodies do. Whereas these are applied in doses of milligrams or grams, Triomab® antibodies work in the range of micrograms and can thus be produced in much smaller facilities.
Triomabâ development dates back to the 1990s with the pioneering work of TRION founder Horst Lindhofer and his team at the Helmholtz Zentrum Munich, Germany. In 1998, he established TRION as a spin-out from the institution in order to exploit the potential of his invention for cancer therapy. “After all these years of intense research and development, it is extremely satisfying to see the first representative of our Triomabâ family reach the market. This success not only demonstrates the innovative potential of public research in Germany, but also provides new hope to patients. The targeted stimulation of an orchestrated immune response by Triomabâ antibodies holds strong potential for the treatment of a broad range of diseases.”
EpCAM or epithelial cell adhesion molecule is a pan-epithelial differentiation antigen that is expressed on almost all carcinomas, such as breast, lung, colorectal, gastric, prostate, head and neck, pancreatic and ovarian cancer. Currently, there is no other approved anti-EpCAM therapy available.
Triomab®: Trifunctional antibodies
The trifunctional antibody Removab® is a member of the Triomab® familiy. Triomab® antibodies bind to cancer-specific surface antigens and recruit both T-cells as well as accessory cells, such as macrophages, dendritic cells and natural killer cells, to the tumor site. As a result, they provide for a new quality of cancer cell killing, activating both arms of the immune system – the adaptive one with cytotoxic T cells as effectors and the innate one including accessory effector cells. Triomab® antibodies are therefore very effective in destroying cancer cells and show a therapeutic effect at very low doses. Triomab® antibodies are a development of TRION Pharma GmbH.
TRION Pharma GmbH is a biopharmaceutical company developing trifunctional antibodies (Triomab®). The trifunctional antibodies are produced at TRION’s site in Munich, Germany, and are based on a proprietary platform technology for which TRION has secured IP rights around the world. For more information please visit the company's website at www.trionpharma.com.
Fresenius Biotech GmbH, 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 further information please visit www.fresenius-biotech.com.
Fresenius SE is a German health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2008, group sales were approx. € 12.3 billion. On December 31, 2008 the Fresenius Group had 122,217 employees worldwide. For more information please visit www.fresenius.com.