Introgen (INGN) off 41% to penny stock status, as the FDA unsurprisingly refuses to accept the Advexin NDA:
>>Introgen Receives Notice ADVEXIN(R) U.S. BLA Not Sufficiently Complete to File
Tuesday September 2, 7:30 am ET
Introgen Intends to Appeal FDA Decision
AUSTIN, Texas--(BUSINESS WIRE)--Introgen Therapeutics, Inc. (NASDAQ:INGN - News), a developer of targeted molecular therapies for cancer, today announced that the United States Food and Drug Administration (FDA) notified the Company that its Biologics License Application (BLA) for ADVEXIN® (p53 tumor suppressor therapy) for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck, submitted on June 30, 2008, was not sufficiently complete and would not be filed at this time. The Company intends to appeal this refuse to file decision and is reviewing the various options available to it.
Earlier this month, Introgen and its subsidiary Gendux Molecular Limited announced that the European Medicines Agency (EMEA) accepted for review the Company’s ADVEXIN Marketing Authorization Application (MAA) for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck.
“We believe in the potential of ADVEXIN as a treatment option for head and neck cancer, an area of significant unmet need for today’s cancer patient,” said David G. Nance, Introgen’s CEO. “We are encouraged by our clinical data and believe that the 40,000 Americans who are diagnosed with head and neck cancer each year would benefit from ADVEXIN as a treatment option in the future. We will work with FDA to determine our next steps in the U.S. as we continue to pursue potential approval in Europe.”
About ADVEXIN
ADVEXIN p53 therapy 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 tumor growth control in recurrent head and neck cancer patients. ADVEXIN has demonstrated clinical activity in a number of solid tumor types in multiple Phase 1, 2 and 3 clinical trials conducted worldwide. ADVEXIN is considered an 'Orphan Drug' in the U.S. for the treatment of recurrent, refractory head and neck cancer, which, if approved, entitles the drug to extended market exclusivity for the approved indication. ADVEXIN is a registered trademark describing p53 therapy, developed by Introgen under exclusive worldwide licenses from The University of Texas M.D. Anderson Cancer Center.<<
Appeals, generally have no chance, and this one has less than most. If INGN management hadn't been so disingenuous about the whole regulatory and clinical experience with Advexin, I'd say this looks interesting for other things in the pipe.
But I won't. Current management has to go before I'd call INGN a buying opportunity.
Cheers, Tuck |
