24 Jul 2015
Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces that further to the Company’s announcement on Friday 17 July 2015, the US Food & Drug Administration (“FDA”) has designated iclaprim, a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria, as a Qualified Infectious Diseases Product (“QIDP”) for hospital acquired bacterial pneumonia (“HABP”), the final condition of the £22 million placing which was announced on 23 June 2015 has been satisfied. The satisfaction of the other condition, the shareholders approving resolutions related to the placing at a General Meeting, was announced by the Company on 10 July 2015.
The Company expects that admission and dealings in the 44,000,000 placing shares (the “Placing Shares”) will commence on 27 July 2015.
As previously announced, the Company requested QIDP designation for iclaprim for two serious and life threatening infections, HABP and acute bacterial skin and skin structure infections (“ABSSSI”). QIDP designation has been confirmed for HABP and an additional administrative step has been requested by the FDA in order to confirm QIDP designation for ABSSSI. Motif has already complied with the requested additional administrative step and is awaiting confirmation of the grant of QIDP designation for ABSSSI from the FDA, which is expected shortly.
QIDP designation, provided under the Generating Antibiotic Incentives Now Act (“GAIN Act”), makes iclaprim eligible for certain incentives, including priority review and fast track designation. QIDP designation also means that iclaprim is eligible for an additional five-year extension of Hatch-Waxman exclusivity, giving a total of 10 years of market exclusivity which will run from the date of approval.
Graham Lumsden, CEO of Motif Bio plc said:
“QIDP designation for iclaprim for HABP is an important step in continuing to build the value of iclaprim and is another positive for Motif and our investors. We believe that iclaprim is the first and only dihydrofolate reductase inhibitor to receive QIDP designation.
“Further, we are delighted to have satisfied the final condition of our recently announced placing, and with the support of our investors look forward to commencing the Phase III trials for iclaprim and further advancing the Company’s portfolio”
Total Voting Rights
Following admission of the Placing Shares, the total issued share capital of the Company will be 108,346,216 ordinary shares with one voting right each. The Company does not hold any shares in treasury.
Accordingly, the total voting rights in the Company will be 108,346,216. This figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the share capital of the Company under the Disclosure and Transparency Rules of the UK Financial Conduct Authority.