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European Regulatory Authority Recommends Orphan Drug Designation for MediGene's Drug Candidate EndoTAG-1

12 Oct 2006 - MediGene AG announced that the European Medicines Agency (EMEA) has recommended granting of orphan drug designation for MediGene's drug candidate EndoTAG-1 in the indication pancreatic cancer. This recommendation is subject to the European Commission's approval.
 
Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: "The orphan drug designation will facilitate the development of EndoTAG-1 for the treatment of pancreatic cancer significantly. Market exclusivity will add an additional level of protection to the existing patent protection and thereby enhances our product's competitive position."
 
MediGene's EndoTAG technology aims at "starving out" tumors. EndoTAG consists of a therapeutic substance embedded in a liposome carrier. The positively charged carrier transports the substance directly to the newly developed tumor blood vessels. The substance destroys the blood vessels, thus suppressing the tumor's nutrient supply. Currently a clinical phase II trial is in progress to test EndoTAG-1 for the treatment of pancreatic cancer. Initiation of another phase II trial in the indication hormone-resistant breast cancer is planned before the end of this year.