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EMEA grants marketing approval for Tepadina

Singapore, Mar 19, 2010: Italy's Adienne Pharma & Biotech and Riemser Arzneimittel of Germany have announced that the European Medicines Agency (EMA) has granted the exclusive marketing authorization to Adienne Pharma & Biotech for the orphan medicinal product Tepadina for conditioning treatment prior to haematopoietic progenitor cell transplantation.

Riemser Arzneimittel is the exclusive worldwide manufacturer. The companies agreed to commercialize the product in close cooperation in their respective territories.

Tepadina can be used to treat haematological diseases such as leukaemia, lymphoma, multiple myeloma and thalassemia and also specific solid tumours (e.g. breast cancer, CNS tumors, ovarian cancer and germ cell tumors) where allogenic or autologous haematopoietic progenitor cell transplantation is a treatment option.

"Adienne Pharma and Biotech mission has always been the research and development of orphan drugs for the treatment of severe diseases with particular attention to the field of transplant. Thanks to the exclusive marketing authorization granted to our Orphan Drug Tepadina we are fulfilling our company mission. I am also very pleased with the support received by Riemser Arzneimittel for Tepadina production and I’m also confident in future cooperation between the two companies", Dr. Antonio Francesco Di Naro, Founder and CEO of Adienne Pharma and Biotech, says.

"I am very grateful to Adienne Pharma & Biotech whose tremendous and highly professional efforts resulted in the granted license for Tepadina. The international, innovative cooperation between our two companies now allows us to offer critically ill patients who are dependent on such treatment an effective therapeutic option", Dr. Michael Mehler, CEO of Riesmer Arzneimittel AG, notes.

© BioSpectrum Bureau
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