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
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."
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