EMA Grants to ADIENNE Exclusive Marketing Authorization for TEPADINA®
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|Thursday, 18 March 2010 16:30 (UTC + 1)|
Commercialization in close cooperation with RIEMSER Arzneimittel AG
TEPADINA® obtained Orphan Drug Designations by the EMA for the indication “Conditioning treatment prior to haematopoietic progenitor cell transplantation” and by US Food and Drug Administration (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 (e.g. breast cancer, CNS tumours, ovarian cancer and germ cell tumours) 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 AG 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 RIEMSER Arzneimittel AG, notes.
TEPADINA® will be available in Italy and Spain through ADIENNE Pharma & Biotech and in Germany through RIEMSER Arzneimittel AG. Further countries will follow successively, wherein close cooperation in marketing and regional distribution in the European Union is agreed upon.
The companies will now enter into discussions with the respective local authorities to commercialize TEPADINA®.
"With the launch of TEPADINA® we at RIEMSER will consistently continue our strategic orientation as a specialty pharma company. We are strengthening our key therapeutic area of oncology and haematology and further expanding our international presence", Dr. Michael Mehler, CEO of RIEMSER Arzneimittel AG, emphasizes.
Contact: Franziska Hannemann
TEPADINA® is indicated, in combination with other chemotherapy medicinal products:
TEPADINA® has received great attention because is one of the alkylating agents with the lowest extramedullary toxicity and, having the peculiarity to cross the blood brain barrier, it reaches the same plasmatic concentration in the cerebrospinal fluid. The advantage of using TEPADINA® in the conditioning regimen is the high myeloablative and immunosuppressive effects associated with a low toxicity profile and this of course makes it an attractive agent whenever there is a need to eradicate the disease and also to enhances engraftment in different transplant settings. TEPADINA® could be associated with other chemotherapy drugs used in conditioning regimen prior to autologous and allogenic haematopoietic progenitor cell transplantation without increase toxicity. Moreover, TEPADINA® is covering all patient age, from paediatric to adult, giving the opportunity to physicians to manage a dose escalating treatment.
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