STOCKHOLM, Sweden and AUSTIN, Texas, October 31 /PRNewswire/ --
- European Commission Confirms ADVEXIN as Orphan Drug for Li-FraumeniSyndrome Cancers
Gendux AB and Introgen Therapeutics, Inc. (Nasdaq: INGN) announced todaythat they have reached agreement with the European Medicines Agency (EMEA)Committee to file for ADVEXIN(R) p53 therapy marketing approval under theEMEA's Exceptional Circumstances provisions. The application will be for theuse of ADVEXIN p53 therapy for the treatment of Li-Fraumeni Syndrome (LFS).LFS is a genetic disorder characterized by inherited mutations in the p53tumor suppressor gene. Due to these mutations, LFS patients suffer fromnumerous cancers often presenting with tumors at an early age. Exceptionalcircumstances provisions are designed to facilitate access to neededtreatments for certain Orphan Medicinal Products.
Gendux also announced that ADVEXIN has been confirmed by the EuropeanCommission as an Orphan Medicinal Product and has been entered in theEuropean Community register on orphan medical products under the numberEC/3/06/404. In a related European regulatory action, last month ADVEXIN wasrecommended for Orphan Drug Status for the treatment of LFS by the EMEA'sCommittee on Orphan Medicinal Products. Orphan drug registration in Europeconfers a number of regulatory and commercial benefits for the productincluding access to protocol assistance, reduced regulatory fees and a10-year period of marketing exclusivity from the date of marketingauthorization approval.
Introgen and Gendux previously announced that ADVEXIN p53 therapy isavailable on a compassionate use basis to qualified LFS cancer patients.
Dr. Max W. Talbott, senior vice president of Worldwide CommercialDevelopment and Regulatory Affairs at both Introgen and Gendux said, "Aftervery positive discussions with the EMEA, we plan to utilize the Europeanregulatory approach of Exceptional Circumstances Approval to file a marketingapplication for LFS. This special provision in the European rules allows usto seek an expedited registration of ADVEXIN in Europe while at the same timeadvancing our head and neck registrations both in Europe as well as theUnited States."
Over the coming months Introgen and Gendux plan to complete the filing ofADVEXIN applications for the European approval of LFS treatment, the Europeanapproval for head and neck cancer, and the U.S. approval for head and neckcancer. The compatibility of EU and U.S. filing and submission requirementsfacilitate the achievement of these regulatory filing objectives. Introgenand Gendux intend to provide periodic updates on regulatory progress withtargeted completion of all applications during the second half of 2007.
Dr. Talbott further stated, "European and U.S. authorities are to becommended for providing regulatory pathways that are conducive to thedevelopment of novel, breakthrough cancer therapies such as ADVEXIN. We arecommitted to expediting ADVEXIN's availability in U.S. and European markets.As we strive to progress ADVEXIN's registration over the coming months, welook forward to providing specific updates on European and US regulatoryevents."
About ADVEXIN
ADVEXIN is a targeted molecular therapy with broad applicability in awide range of tumor types and clinical settings because it targets one of themost fundamental and common molecular defects, abnormal p53 tumor suppressorfunction, associated with cancer initiation, progression and treatmentresistance. ADVEXIN has demonstrated increased survival and durablelocoregional disease control in recurrent head and neck cancer patients.Prognostic biomarkers can identify patients most likely to respond toADVEXIN. ADVEXIN has demonstrated clinical activity in a number of solidtumor types in multiple phase 1, 2 and 3 clinical trials conducted worldwide.A request for accelerated approval review for ADVEXIN is now pending at theU.S. Food and Drug Administration (FDA). The FDA has selected ADVEXIN as afast track program for an unmet medical need and has designated ADVEXIN fororphan drug use for recurrent head and neck cancer.
Introgen expects that an interim efficacy analysis plan for its Phase 3head and neck cancer studies will be agreed to by the FDA before the end of2006. Additional regulatory milestones anticipated for completion during 2007include: Completion and submission to FDA of the Phase 3 interim efficacyanalysis data for head and neck cancer; Conditional Approval approach forhead and neck cancer application agreed to by EMEA; and, ExceptionalCircumstance Approval Application filing for Li-Fraumeni Syndrome completedwith the EMEA. Introgen also anticipates that during 2007, all of thenecessary filings will be completed for head and neck cancer at FDA and EMEAto support review and advisory committee review meetings, if required, bythese agencies.
About Li-Fraumeni Syndrome
Li-Fraumeni Syndrome (LFS) is an inherited genetic disorder that greatlyincreases the risk of developing several types of cancer typically withinitial occurrence at a young age. The majority of LFS families haveinherited mutations in the p53 tumor suppressor gene. The treatment ofLi-Fraumeni tumors with ADVEXIN p53 represents therapy targeted to themolecular defect underlying the cause and progression of these cancers.
About Gendux AB
Gendux AB is engaged in the development and commercialization oftargeted, molecular medicines for European markets. Gendux uses therapeuticgenes and other agents in a variety of nano-scale delivery systems to treatdisease at the molecular and cellular level. Gendux is developing less toxic,novel biopharmaceutical products to address unmet medical needs. Gendux AB isa wholly owned subsidiary of Introgen Therapeutics, Inc. (Nasdaq: INGN), aleader 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 thediscovery, development and commercialization of targeted molecular therapiesfor the treatment of cancer and other diseases. Introgen is developingmolecular therapeutics, immunotherapies, vaccines and nano-particle therapiesto treat a wide range of cancers using tumor suppressors and cytokines.Introgen maintains integrated research, development, manufacturing, clinicaland regulatory departments and operates multiple manufacturing facilitiesincluding 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 ofIntrogen's ADVEXIN(R) p53 therapy marketing approval under the EMEA'sExceptional Circumstances provisions, the agreement with the FDA to theinterim analysis plan, the regulatory benefits conferred by the OrphanMedicinal Product Designation for Europe and the Orphan Drug Designation inthe US, and the regulatory timelines and filings as stated by Introgen. Theactual results may differ from those described in this release due to risksand uncertainties that exist in Introgen's operations and businessenvironment, including Introgen's stage of product development and thelimited experience in the development of gene-based drugs in general,dependence upon proprietary technology and the current competitiveenvironment, history of operating losses and accumulated deficits, relianceon collaborative relationships, and uncertainties related to clinical trials,the safety and efficacy of Introgen's product candidates, the ability toobtain the appropriate regulatory approvals, Introgen's patent protection andmarket acceptance, as well as other risks detailed from time to time inIntrogen's filings with the Securities and Exchange Commission including itsfilings on Form 10-K and Form 10-Q. Introgen undertakes no obligation topublicly release the results of any revisions to any forward-lookingstatements that reflect events or circumstances arising after the datehereof.
Editor's Note: For more information on Introgen Therapeutics, or for amenu of archived press releases, please visit Introgen's Website at:http://www.introgen.com.
Contact: Introgen Therapeutics, Inc. C. Channing Burke +1-(512)-708-9310 Ext. 322 Email: c.burke@introgen.com
Web site: http://www.introgen.com
Introgen Therapeutics, Inc.
C. Channing Burke of Introgen Therapeutics, Inc., +1-512-708-9310, Ext. 322, c.burke@introgen.com
