March 22, 2010: ADIENNE Pharma & Biotech and RIEMSER Arzneimittel AG have announce that the European Medicines Agency (EMEA) has granted the exclusive marketing authorisation to ADIENNE Pharma & Biotech for the orphan medicinal product TEPADINA® for conditioning treatment prior to haematopoietic progenitor cell transplantation. RIEMSER Arzneimittel AG is the exclusive worldwide manufacturer. The companies agreed to commercialise the product in close cooperation in their respective territories.
TEPADINA obtained Orphan Drug Designations by the EMEA for the indication “Conditioning treatment prior to haematopoietic progenitor cell transplantation” and by the FDA for the indication “Conditioning treatment prior to haematopoietic stem cell transplantation” in 2007.
TEPADINA can be used to treat haematological diseases such as leukaemia, lymphoma, multiple myeloma and thalassemia and also specific solid tumours (eg breast cancer, CNS tumours, ovarian cancer and germ cell tumours) where allogenic or autologous haematopoietic progenitor cell transplantation is a treatment option.
The drug will be available in Italy and Spain through ADIENNE Pharma & Biotech and in Germany through RIEMSER Arzneimittel AG. Further countries will follow successively, where close cooperation in marketing and regional distribution in the EU has been agreed upon. The companies will now enter into discussions with the respective local authorities to commercialise TEPADINA.
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