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Liposomal Daunorubicin Receives Orphan Medicinal Product Designation in European Union for the Treatment of Acute Myeloid Leukaemia

CRAIGAVON, Northern Ireland, November 15, 2012 /PRNewswire/ --

Galen announced today that the European Commission has designated liposomal daunorubicin as an orphan medicinal product for the treatment of acute myeloid leukaemia (AML).[1]  The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA).[2]  Liposomal daunorubicin is currently approved in a number of European countries, the U.S. and Brazil for the treatment of advanced HIV-related Kaposi's sarcoma, as the medicinal product DaunoXome®.

Acute myeloid leukaemia is estimated to affect not more than 1.2 in 10,000 people in the European Union.  It is chronically debilitating and life threatening due to bone marrow dysfunction. If left untreated, the condition progresses rapidly and is often fatal.[2]

Galen is dedicated to supporting the development and provision of innovative medicines in an effort to improve health worldwide.  Speaking about the European Commission orphan medicinal product designation for liposomal daunorubicin, Mark Scrutton, President of Galen, commented: "We are delighted about the designation of liposomal daunorubicin as an orphan medicinal product for the treatment of acute myeloid leukaemia, a life-threatening disease. We have recently taken our first step into the oncology arena, and the orphan designation of liposomal daunorubicin provides further opportunity for development of this product in the treatment of patients with AML."  

Notes to Editor:

About liposomal daunorubicin: Liposomal daunorubicinis an anthracycline chemotherapy agent which is currently approved in a number of European countries, the U.S. and Brazil for the treatment of advanced HIV-related Kaposi's sarcoma, as the medicinal product DaunoXome®. It works by attacking cancer cells and interfering with DNA production, which stops cancer cells from multiplying.[3] The product has a different delivery system compared with conventional anthracyclines; it has a type of liposomal coating and particle size, which enables it to effectively target malignant tumours.[4],[5],[6]

About Galen:

Galen is a privately owned, global pharmaceutical company headquartered in Northern Ireland, UK.  Galen's products are now available in 16 countries and the company is working to expand its global reach with the formation of international strategic partnerships.  A substantial drug discovery operation is underway, focusing on products for the treatment of cancer.  


  1. Community Register of Orphan Medicinal Products for Human Use, EU Designation: EU/3/12/1056. Available from (accessed on 01 November 2012).
  2. Committee for Orphan Medicinal Products (COMP) Minutes of the 4-5 September 2012 Meeting, EMA/COMP/471400/2012, 05 October 2012.
  3. Brunton LL, Chabner BA, Knollmann BC, editors. Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12th edition.  New York, Chicago, San Francisco, McGraw-Hill.  2011: 1671.
  4. DaunoXome® Injection (liposomal daunorubicin) UK Summary of Product Characteristics 30 October 2011.
  5. Forssen EA et al.  Fluorescence Imaging Studies for the Disposition of Daunorubicin Liposomes (DaunoXome) within Tumor Tissue. Cancer Res 1996;56:2066-2075.
  6. Forssen EA.  The design and development of DaunoXome for solid tumor targeting in vivo.  Advanced Drug Delivery Reviews 1997; 24: 133-150.


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