STOCKHOLM, Sweden and AUSTIN, Texas, Oct. 31 /PRNewswire-FirstCall/ -- Gendux AB and Introgen Therapeutics, Inc. announced today that they have reached agreement with the European Medicines Agency (EMEA) Committee to file for ADVEXIN(R) 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."
ADVEXIN is a targeted molecular therapy with broad applicability in a wide range of tumor types and clinical settings because it targets one of the most fundamental and common molecular defects, abnormal p53 tumor suppressor function, associated with cancer initiation, progression and treatment resistance. ADVEXIN has demonstrated increased survival and durable locoregional disease control in recurrent head and neck cancer patients. Prognostic biomarkers can identify patients most likely to respond to ADVEXIN. ADVEXIN has demonstrated clinical activity in a number of solid tumor types in multiple phase 1, 2 and 3 clinical trials conducted worldwide. A request for accelerated approval review for ADVEXIN is now pending at the U.S. Food and Drug Administration (FDA). The FDA has selected ADVEXIN as a fast track program for an unmet medical need and has designated ADVEXIN for orphan drug use for recurrent head and neck cancer.
Introgen expects that an interim efficacy analysis plan for its Phase 3 head and neck cancer studies will be agreed to by the FDA before the end of 2006. Additional regulatory milestones anticipated for completion during 2007 include: Completion and submission to FDA of the Phase 3 interim efficacy analysis data for head and neck cancer; Conditional Approval approach for head and neck cancer application agreed to by EMEA; and, Exceptional Circumstance Approval Application filing for Li-Fraumeni Syndrome completed with the EMEA. Introgen also anticipates that during 2007, all of the necessary filings will be completed for head and neck cancer at FDA and EMEA to support review and advisory committee review meetings, if required, by these agencies.
About Li-Fraumeni Syndrome
Li-Fraumeni Syndrome (LFS) is an inherited genetic disorder that greatly increases the risk of developing several types of cancer typically with initial occurrence at a young age. The majority of LFS families have inherited mutations in the p53 tumor suppressor gene. The treatment of Li-Fraumeni tumors with ADVEXIN p53 represents therapy targeted to the molecular defect underlying the cause and progression of these cancers.
About Gendux AB
Gendux AB is engaged in the development and commercialization of targeted, molecular medicines for European markets. Gendux uses therapeutic genes and other agents in a variety of nano-scale delivery systems to treat disease at the molecular and cellular level. Gendux is developing less toxic, novel biopharmaceutical products to address unmet medical needs. Gendux AB is a wholly owned subsidiary of Introgen Therapeutics, Inc. , a leader in the field of molecular oncology. Gendux is based in Stockholm, Sweden with offices in London UK.
About Introgen Therapeutics, Inc.
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is developing molecular therapeutics, immunotherapies, vaccines and nano-particle therapies to treat a wide range of cancers using tumor suppressors and cytokines. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility.
Statements in this release that are not strictly historical may be "forward-looking" statements, including those relating to the filing of Introgen's ADVEXIN(R) p53 therapy marketing approval under the EMEA's Exceptional Circumstances provisions, the agreement with the FDA to the interim analysis plan, the regulatory benefits conferred by the Orphan Medicinal Product Designation for Europe and the Orphan Drug Designation in the US, and the regulatory timelines and filings as stated by Introgen. The actual results may differ from those described in this release due to risks and uncertainties that exist in Introgen's operations and business environment, including Introgen's stage of product development and the limited experience in the development of gene-based drugs in general, dependence upon proprietary technology and the current competitive environment, history of operating losses and accumulated deficits, reliance on collaborative relationships, and uncertainties related to clinical trials, the safety and efficacy of Introgen's product candidates, the ability to obtain the appropriate regulatory approvals, Introgen's patent protection and market acceptance, as well as other risks detailed from time to time in Introgen's filings with the Securities and Exchange Commission including its filings on Form 10-K and Form 10-Q. Introgen undertakes no obligation to publicly release the results of any revisions to any forward-looking statements that reflect events or circumstances arising after the date hereof.
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Introgen Therapeutics, Inc.
C. Channing Burke
(512) 708 9310 Ext. 322
Introgen Therapeutics, Inc.