BTA biota holdings limited

UpdateRecent Corporate DevelopmentsLaninamivir Octanoate/BARDA -...

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    Update

    Recent Corporate Developments

    Laninamivir Octanoate/BARDA - On April 29, 2014, the Company announced that it had been notified by the U.S. Department of Health and Human Services (HHS) office of the Assistant Secretary for Preparedness and Response (ASPR) and Biomedical Advanced Research and Development Authority (BARDA) that pending a decision regarding the outcome of a recent In-Process Review (IPR) of the Company's contract for the development of laninamivir octanoate, ASPR/BARDA has issued a Stop-Work Order notifying the Company to discontinue work on a number of activities under this contract. In the interim, the Company indicated it intends to comply with the order and is focusing its efforts on critical path activities not covered by the order, namely completing the conduct of and finalizing the data from its Phase 2 IGLOO trial. The Company also reported that it anticipates top-line data from the IGLOO trial will be available in the third quarter of 2014.

    On April 30, 2014, the Company announced that an interim update had been provided from HHS and BARDA with respect to the Stop-Work Order and the pending IPR decision, with BARDA indicating that a Stop-Work Order was not a contract termination, and due to fact that the project was at a natural pause following the end of the influenza season for the Northern Hemisphere, HHS/BARDA was considering the best next step for the Biota project and the overall influenza antiviral drug development program before going forward with clinical studies in the Southern Hemisphere and manufacturing optimization and validation.

    Public Offering - In January 2014, the Company reported that it had priced a public offering of 5,813,900 shares of the Company's common stock at a purchase price of $4.30 per share. Later in January, the Company further reported that the underwriter had exercised its option to purchase 872,085 additional shares at the public offering price to cover over-allotments. The net proceeds to the Company from the sale of the shares, including the overallotment, after underwriting discounts and commissions and other offering expenses, were approximately $26.8 million. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.



    Read more: http://www.nasdaq.com/press-release/biota-pharmaceuticals-reports-third-quarter-2014-financial-results-and-recent-corporate-developments-20140506-01548#ixzz30yQwICvS
 
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