Introgen Therapeutics and Gendux AB Announce Agreement With European Medicines Agency to File for ADVEXIN Approval Under Exceptional Circumstance Rules
Tuesday October 31, 3:00 am ET
European Commission Confirms ADVEXIN as Orphan Drug for Li-Fraumeni Syndrome Cancers
STOCKHOLM, Sweden and AUSTIN, Texas, Oct. 31 /PRNewswire-FirstCall/ -- Gendux AB and Introgen Therapeutics, Inc. (Nasdaq: INGN - News) announced today that they have reached agreement with the European Medicines Agency (EMEA) Committee to file 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. Due to these mutations, LFS patients suffer from numerous cancers often presenting with tumors at an early age. 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 and has been entered in the European Community register on orphan medical products under the number EC/3/06/404.
In a related European regulatory action, last month ADVEXIN was recommended for Orphan Drug Status for the treatment of LFS by the EMEA's Committee on Orphan Medicinal Products. 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 authorization approval.
Introgen and Gendux previously announced that ADVEXIN p53 therapy is available on a compassionate use basis to qualified LFS cancer patients.
Dr. Max W. Talbott, senior vice president of Worldwide Commercial Development and Regulatory Affairs at both Introgen and Gendux said, "After very positive discussions with the EMEA, we plan to utilize the European regulatory approach of Exceptional Circumstances Approval to file a marketing application for LFS. This special provision in the European rules allows us to seek an expedited registration of ADVEXIN in Europe while at the same time advancing our head and neck registrations both in Europe as well as the United States."
Over the coming months Introgen and Gendux plan to complete the filing of ADVEXIN applications for the European approval of LFS treatment, the European approval for head and neck cancer, and the U.S. approval for head and neck cancer.
The compatibility of EU and U.S. filing and submission requirements facilitate the achievement of these regulatory filing objectives. Introgen and Gendux intend to provide periodic updates on regulatory progress with targeted completion of all applications during the second half of 2007.
Dr. Talbott further stated, "European and U.S. authorities are to be commended for providing regulatory pathways that are conducive to the development of novel, breakthrough cancer therapies such as ADVEXIN. We are committed to expediting ADVEXIN's availability in U.S. and European markets. As we strive to progress ADVEXIN's registration over the coming months, we look forward to providing specific updates on European and US regulatory events."
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