DARA Biosciences Reports Waiver of Product Granted, Fees by FDA Established

DARA BioSciences, Inc.

, an oncology supportive care pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatment, today announced that it has been granted a "barrier-to-innovation" waiver for certain product and establishment fees. The Food and Drug Administration (FDA) has granted DARA's request for a barrier-to-innovation waiver of the Fiscal Year 2012 product and establishment fees, Fiscal Year 2013 product fee, and Fiscal Year 2014 product and establishment fees for NDA, 21-807, Soltamox oral solution totali ng approximately $1.1 million. A waiver or reduction in PDUFA fees may be appropriate when (1) the product for which the waiver is being requested is innovative or the entity requesting the waiver is otherwise pursuing innovative drug products or technology, and (2) the fee would be a significant barrier to the entity's ability to develop, manufacture, or market innovative products or technology. Specifically, the FDA acknowledged DARA's development work surrounding its KRN5500 asset during the years relating to the waiver, and determined that the imposition of the fees during those years created a significant financial barrier to the Company. DARA has requested a similar waiver for 2015. The FDA's Office of Financial Management (OFM) has been directed to refund the fees related to fiscal year 2012 already remitted by DARA in the amount of approximately $619 thousand, which should be processed and refunded within 30 days from the waiver being granted. The fees related to fiscal years 2013 and 2014 which have not been remitted total approximately $480 thousand. The FDA plans to publicly disclose information about its actions granting or denying waivers and reductions, which will be consistent with the laws and regulations governing the disclosure of confidential commercial or financial information.