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Elite Pharmaceuticals, Inc. Message Board

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  • gmger21 gmger21 Jul 2, 2011 1:48 AM Flag


    maybe this will help?

    This is very good to elite with FDA guidance for ELI-216

    Elite met with the FDA for a Type C clinical guidance meeting regarding the NDA development program for ELI-216. Elite has incorporated
    the FDA’s guidance into its developmental plan. Elite has obtained a special protocol assessment, or SPA, with the FDA for the ELI-216 Phase
    III protocol. Elite will conduct additional Phase I studies including, but not limited to, food effect, ascending dose and multi-dose studies.
    Elite has developed ELI-154 and ELI-216 and retains the rights to these products. Elite has currently chosen to develop these products itself but
    expects to license these products at a later date to a third party who could provide funding for the remaining clinical studies, including a Phase III
    study, and who could provide sales and distribution for the product. The drug delivery technology underlying ELI-154 was originally developed
    under a joint venture with Elan which terminated in 2002.
    According to the Elan Termination Agreement, Elite acquired all proprietary, development and commercial rights for the worldwide markets for
    the products developed by the joint venture, including ELI-154. Upon licensing or commercialization of ELI-154, Elite will pay a royalty to Elan
    pursuant to the Termination Agreement. If Elite were to sell the product itself, Elite would pay a 1% royalty to Elan based on the product’s net
    sales, and if Elite enters into an agreement with another party to sell the product, Elite will pay a 9% royalty to Elan based on Elite’s net
    revenues from this product. (Elite’s net product revenues would include license fees, royalties, manufacturing profits and milestones) Elite is
    allowed to recoup all development costs including research, process development, analytical development, clinical development and regulatory
    costs before payment of any royalties to Elan

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