Dacogen(TM) (Decitabine) For Injection Receives European Orphan Drug Designation for Patients With AML
MINNEAPOLIS, Aug 01, 2006 (BUSINESS WIRE) -- MGI PHARMA, INC. (Nasdaq: MOGN), a biopharmaceutical company focused in oncology and acute care, today announced that the European Medicines Agency (EMEA) has granted Dacogen(TM) (decitabine) for Injection orphan designation for the indication of acute myeloid leukemia (AML). Dacogen was approved by the U.S. Food and Drug Administration (FDA) on May 2, 2006 for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System (IPSS) groups. The orphan drug designation was established by the EMEA to encourage the development of treatments for rare, life threatening medical conditions that affect fewer than five in 10,000 people in the European Union (EU). This designation may also provide 10 years of market exclusivity in the EU following marketing approval. Dacogen was previously designated as an orphan drug by the EMEA for the MDS indication.
Dacogen is being co-developed by MGI PHARMA and Janssen-Cilag, a Johnson & Johnson company. Janssen-Cilag companies are responsible for regulatory and commercial activities in all territories outside North America, while MGI PHARMA retains responsibility for all activities in the United States, Canada and Mexico.