|Date Set for Arbitration Trial between CEL-SCI and inVentiv; DARA Granted Waiver of Product and Establishment Fees|
|By David Fowler|
|Tuesday, 06 January 2015 20:23|
CEL-SCI Corporation (NYSE MKT:CVM) announced the trial in its ongoing arbitration against inVentiv Clinical LLC (f/k/a PharmaNet LLC and PharmaNet GmbH (f/k/a PharmaNet AG)) a clinical research organization is currently scheduled for May 4 2015.
CEL-SCI initiated an arbitration claim against inVentiv in October 2013. CEL-SCI initially retained inVentiv to conduct the Phase III clinical trial of CEL-SCI's investigational drug Multikine* (Leukocyte Interleukin Injection). CEL-SCI terminated inVentiv in or about April 2013 and replaced inVentiv with new clinical research organizations. CEL-SCI's arbitration claim is initiated under the Commercial Rules of the American Arbitration Association alleging (i) breach of contract (ii) fraud in the inducement and (iii) common law fraud and seeks at least $50 million in damages.
About Multikine -- Multikine* (Leukocyte Interleukin Injection) is an investigational immunotherapeutic agent that is being tested in an open-label randomized controlled global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in about 20 countries.
In October 2013 CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center San Diego to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.
About CEL-SCI Corporation -- CEL-SCI’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy Multikine (Leukocyte Interleukin Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include cervical dysplasia in HIV/HPV co-infected women and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA (Cooperative Research and Development Agreement).
DARA BioSciences, Inc. (NASDAQ: DARA), 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, announced 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 totaling 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.
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