EMA Grants to ADIENNE Exclusive Marketing Authorization for TEPADINA®

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Thursday, 18 March 2010 16:30 (UTC + 1)
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Commercialization in close cooperation with RIEMSER Arzneimittel AG

Greifswald–Insel Riems / Bergamo, March 18, 2010 / b3c newswire /
- ADIENNE Pharma & Biotech and RIEMSER Arzneimittel AG announce today 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 AG is the exclusive worldwide manufacturer. The companies agreed to commercialize the product in close cooperation in their respective territories.

 

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: Dr. Vincenzo Mistrini
Tel.: +39.035.199. 64047; Fax: +39.035.258.672; This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
ADIENNE Pharma & Biotech, Via Broseta 64/B, 24128 Bergamo, Italy, www.adienne.com

 

Contact: Franziska Hannemann
Tel.: +49 38351-76-129, Fax: +49 38351-7648, This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
RIEMSER Arzneimittel AG, An der Wiek 7, 17493 Greifswald-Insel Riems, Germany, www.RIEMSER.com

 

About TEPADINA®:
The active substance thiotepa was originally developed as a cytostatic agent for solid tumours. With its licensing for conditioning therapy prior to progenitor cell transplantation (classification as a "rare disorder", orphan drug status), a specific additional application becomes possible.

 

TEPADINA® is indicated, in combination with other chemotherapy medicinal products:
  1. 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;
  2. when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.

 

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.

 

About ADIENNE Pharma & Biotech: A company exclusively dedicated to Orphan Drugs
ADIENNE Pharma & Biotech is a mid-size bio-pharmaceutical company founded in 2004, dedicated to the treatment of rare and severe diseases, operating in world wide pharmaceutical market. The headquarter is based in Bergamo (Italy). The company is mainly focused on the fields of onco-haematology, autoimmune diseases, bone marrow and solid organ transplantation. The product portfolio of ADIENNE includes name patient based products (NBP) and owned licensed medicinal products. ADIENNE’ s research and development pipeline consists today in 3 new monoclonal antibodies already granted by EMA and FDA as orphan drugs.
Further information at: www.adienne.com

 

About RIEMSER Arzneimittel AG: A company with a tradition and a future
RIEMSER Arzneimittel AG is a specialised, internationally active mid-sized pharmaceutical company which develops, produces and markets human and veterinary therapeutic agents. In recent years, RIEMSER Arzneimittel AG has been among the fastest growing pharmaceutical companies within Germany. Its main headquarters are in Greifswald (Germany).
The product range of RIEMSER AG in the human field particularly includes prescription medications against skin and infectious disorders, particularly tuberculosis, cancer therapy agents for supportive and palliative care as well as cardiovascular products. In the field of dental medicine, it focuses on bone regeneration with tooth preservation and replacement as well as on an innovative implant system. The portfolio is complemented by products for pain relief and inflammation treatment in cases of dental inflammation. In veterinary medicine, RIEMSER is a specialist particularly in the field of vaccines.
Further information at: www.RIEMSER.com