FIRMS SEEK EMEA APPROVAL FOR DRUG TO TREAT RARE DISORDER

Swedish drugmaker Gendux and Introgen Therapeutics announced they have reached agreement with the European Medicines Agency (EMEA) to apply for Advexin p53 therapy marketing approval under the EMEA's exceptional circumstances provisions. The application will be for the use of Advexin p53 therapy for the treatment of Li-Fraumeni Syndrome (LFS). LFS is a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene. Exceptional circumstances provisions are designed to facilitate access to needed treatments for certain orphan medicinal products.

Gendux also announced that Advexin has been confirmed by the European Commission as an orphan medicinal product. Orphan drug registration in Europe confers a number of regulatory and commercial benefits for the product including access to protocol assistance, reduced regulatory fees and a 10-year period of marketing exclusivity from the date of marketing approval.

Introgen and Gendux previously announced that Advexin p53 therapy is available on a compassionate-use basis to qualified LFS cancer patients. Over the coming months the companies plan to submit applications for European approval of LFS treatment, European approval for head and neck cancer and U.S. approval for head and neck cancer.