European Regulatory Authority Recommends Orphan Drug Designation for MediGene’s Drug Candidate EndoTAG-1
Orphan Drug Designation Ensures Market Exclusivity for Ten Years Following Marketing Authorization
Martinsried/Munich – October 11, 2006. The biotech company MediGene AG (Frankfurt, Prime Standard) announced today 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.
The orphan drug designation ensures EU market exclusivity for the drug for a period of ten years following marketing authorization. Further benefits are a reduction of fees for the regulatory procedure, as well as assistance with the compilation of the protocol and of the clinical dossier. The intent of the EU orphan drug program is to support the development of therapies for rare and severe diseases.
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.”
About EndoTAG-1: 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. EndoTAG-1 is the first drug candidate based on this technology. 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.
This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGeneTM and EndoTAGTM are trademarks of MediGene AG.
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MediGene AG is a publicly quoted (Frankfurt: Prime Standard: MDG) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company with a drug on the market. The NDA for a second drug, Polyphenon® E Ointment, is under review by the FDA. In addition, several drug candidates are currently in clinical development. MediGene also possesses innovative platform technologies. The company’s core competence lies in research and development of novel approaches in anti cancer therapies. Thus MediGene focuses on indications of high medical need and great economic opportunities.
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