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Introgen Therapeutics, Inc. (INGN) And Gendux Announce Orphan Designation For ADVEXIN Therapy In European Union



9/7/2006 1:49:04 PM

STOCKHOLM, Sweden and AUSTIN, Texas, Sept. 7 /PRNewswire-FirstCall/ -- Gendux AB and Introgen Therapeutics, Inc. (Nasdaq: INGN - News) announced today Gendux was notified by the European Medicines Agency (EMEA) Committee for Orphan Medicinal Products that ADVEXIN® p53 therapy has received Orphan Medicinal Product Designation in Europe for the treatment of Li-Fraumeni Syndrome (LFS). LFS is a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene. EU Orphan Designation confers a number of regulatory benefits for the product including access to protocol assistance, reduced regulatory fees and a 10-year period of marketing exclusivity from the date of approval. The Orphan Designation recommended by the EMEA Committee for Orphan Medicinal Products must be ratified by the European Commission, and is expected within 30 days. Gendux is a wholly owned subsidiary of Introgen Therapeutics, Inc.

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