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onco INEX and Enzon Complete the Filing of a New Drug Application for Onco TCS INEX has requested that the Onco TCS NDA be granted a Priority Review as itis a product intended to address an unmet medical need onco. Applications that aregranted Priority Review status are targeted for action by the FDA within sixmonths from the date that the submission is complete. David Main, President and CEO of INEX said, The completion of the filingof the NDA is a significant achievement and signals the start of the six-monthregulatory review phase to seek approval for Onco TCS as a treatment for relapsedaggressive NHL onco. This is an important step forward for these patients who havevery few treatment options. Arthur Higgins, Enzons chairman and chief executive officer, said, Thesubmission of the third and final piece of this NDA supports our commitmentto advance this important therapy to the market place onco. We are eager to continueto investigate this exciting products potential in indications beyondrelapsed aggressive NHL. INEX and Enzon will hear from the FDA within 60 days as to whether or not thesubmission has been accepted for review and given Priority Review status. About Onco TCS Onco TCS is a proprietary drug comprised of the widely used off-patent anticancerdrug vincristine encapsulated in INEXs TCS (liposomal) drug delivery technology onco. The TCS technology provides prolonged blood circulation, tumor accumulationand extended drug release at the cancer site onco. These characteristics are designedto increase the effectiveness and reduce the side effects of the encapsulateddrug. In addition to the lead indication, relapsed aggressive NHL, Enzon and INEXintend to develop Onco TCS for use as a single-agent therapy or in combinationtherapy for several cancers in which vincristine is now used. Onco TCS is being evaluated in several phase II clinical trials as a treatmentfor first-line NHL, relapsed small cell lung cancer, relapsed Hodgkinsdisease, relapsed acute lymphoblastic leukemia, relapsed pediatric malignancies,relapsed NHL in combination with the approved cancer drug Rituxan® (rituximab),and relapsed NHL in combination with the approved cancer drug etoposide. In January 2004, Enzon and INEX announced a strategic partnership to developand commercialize Onco TCS onco. Under the terms of the agreement, Enzon has theexclusive North American commercialization rights for Onco TCS for all indications,subject to certain co-promotion rights of INEX onco. INEX retains commercializationrights outside North America. INEX received a US$12 million up-front payment and will receive up to a US$20million payment upon Onco TCS receiving approval from the FDA onco. Additional developmentmilestones and sales-based bonus payments could total US$43.75 million onco. INEXwill also receive a percentage of sales of Onco TCS and this percentage willincrease as sales reach certain predetermined thresholds. About Non-Hodgkins Lymphoma (NHL) About INEX About Enzon Source: Inex Pharmaceuticals Corporation Advertisement |
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