FDA Grants Orphan Drug Designation for MediGene's Drug Candidate EndoTAG(TM)-1

Orphan drug designation ensures market exclusivity for a period of seven years following market approval

25-May-2009 - Germany

MediGene AG has obtained Orphan Drug Designation from the US regulatory authority FDA (US Food and Drug Administration) for paclitaxel, the active ingredient in MediGene's drug candidate EndoTAG(TM)-1 for the indication pancreatic cancer. Orphan drug designation for EndoTAG(TM)-1 in this indication was already granted in the European Union in 2006.

Dr. Frank Mathias, Chief Executive Officer of MediGene AG, comments: "The orphan drug designation in the USA once more emphasizes the significance of EndoTAG(TM)-1 for the treatment of pancreatic carcinoma, which is very difficult to treat. It facilitates the future scientific exchange between MediGene and the regulatory authority. In addition, it provides financial incentives for the further development of EndoTAG(TM)-1 for the treatment of pancreatic carcinoma. The market exclusivity granted upon market approval enhances patent protection by adding independent protection against copying, thus improving our product's competitive position."

Other news from the department research and development

Most read news

More news from our other portals

So close that even
molecules turn red...