On January 2, 2013 Medical Need reported that it has entered into an exclusive distribution agreement with the Italian company ADIENNE Pharma & Biotech relating to their product Tepadina (Press release, Immedica Pharma, JAN 2, 2013, View Source [SID1234555255]).
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Tepadina was approved as an orphan drug in the EU through an EMA centralized procedure in March 2010. The product holds a broad indication as conditioning therapy, in combination with other products or radiotherapy, in connection with hematopoietic stem cell transplantations (HSCT) and in high dose chemotherapy with HSCT support for the treatment of solid tumors, in both adults and children.
Under the agreement, Medical Need is awarded the exclusive distribution rights to Tepadina in the five Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) and will be responsible for the distribution, marketing and sale of the product in this territory, starting on January 1, 2013.
Tepadina is already used at several clinics in the Nordic countries, both for hematological and solid malignancies. The collaboration between ADIENNE and Medical Need will improve the availability of the product as well as access to medical information and other support services in local language, aiming to make the product available to even more patients across the region.
"Tepadina is a highly valuable and well tolerated component in the treatment of hematological and cerebral malignancies in connection with stem cell transplantation", said Dr. Peder Walberg, CEO of Medical Need, and continued: "We are very happy about the possibility to provide Tepadina to the Nordic patients and look forward to a long-term partnership with ADIENNE"
About Hematopoietic Stem Cell Transplantation (HSCT)
Hematopoietic stem cells reside in the body’s bone marrow and are responsible for the formation of the different cells of the blood. Hematopoietic Stem Cell Transplantation (HSCT), sometimes also referred to as bone marrow transplantation, is a procedure in which hematopoietic stem cells are infused to restore bone marrow function in patients whose own bone marrow has stopped working or been destroyed, commonly because of administration of bone-marrow-toxic doses of cytotoxic drugs with or without whole body radiation therapy for treatment of a malignancy. The new stem cells can come from different sources, including the patient (autologous), a relative (allogeneic related) or an unrelated donor (allogeneic URD). HSCT is commonly performed in connection with treatment of hematological conditions and malignancies, but sometimes also for certain solid tumors, particularly in children. There are approximately 1 500 HSCTs performed in the Nordic countries each year.
About Tepadina
Tepadina (thiotepa) is an alkylating agent with both myeloablative and immunosuppressive properties. It passes the blood brain barrier and has a high degree of CNS penetration and activity. It is commonly used in the treatment of leukemia, lymphoma and CNS tumors. The product is well tolerated, and lacks cumulative toxicity and interactions with other agents commonly used in connection with HSCT.
Tepadina was approved as an orphan drug in the EU through an EMA centralized procedure in March 2010.
Tepadina is indicated, in combination with other chemotherapy medicinal products:
with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients
when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients
The product is available in 15mg and 100mg vials.