MTFB Motif Bio Plc

TIDMMTFB

RNS Number : 3158T

Motif Bio PLC

17 July 2015

17 July 2015

Motif Bio plc.

("Motif" or the "Company")

FDA QIDP Designation for Motif's Lead Antibiotic Candidate Iclaprim for HABP

Motif Bio plc. (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces that the U.S. 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 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 FDA in order to confirm QIDP designation also for ABSSSI. Motif has already complied with the requested additional administrative step and is awaiting confirmation from FDA, expected within the next few days.

The Directors, having consulted with the Company's regulatory and legal advisers, are confident that QIDP designation for ABSSSI will be granted

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. If ultimately approved by the FDA, iclaprim will be eligible for an additional five-year extension of Hatch-Waxman exclusivity, for a total of 10 years of market exclusivity, starting from the date of NDA approval.

On 23 June 2015, the Company announced a GBP22 million placing conditional upon the Company receiving the grant of QIDP status for iclaprim not later than 24 July 2015 and upon shareholders approving the resolution at the General Meeting on 10 July 2015. The shareholder resolutions were approved at the General Meeting.

The Company looks forward to updating the market shortly.

Enquiries

 
 Motif Bio plc.                         info@motifbio.com 
  Graham Lumsden (Chief Executive 
  Officer) 
  Robert Bertoldi (Chief Financial 
  Officer) 
  www.motifbio.com 
 
 Zeus Capital Limited (Nominated        +44 (0) 207 
  Advisor and Broker)                    533 7727 
 Phil Walker / John Treacey 
  Dominic Wilson 
 Northland Capital Partners Limited     +44 (0) 20 
  (Broker)                               7382 1100 
 Patrick Claridge/David Hignell 
  John Howes/Mark Treharne (Broking) 
 Plumtree Capital Limited (Financial 
  Advisor)                              +44 (0) 207 
  Stephen Austin                         183 2493 
 
 
                                          +49 (0) 89 
   MC Services AG (Public Relations)      210 2280 
   Raimund Gabriel                        +44 (0) 207 
   Shaun Brown                            148 5998 
 Yellow Jersey PR Limited (Investor 
  Relations) 
  Dominic Barretto                      +44 (0) 7768 
  Fiona Walker                           537 739 
 

Notes to Editors:

Motif is a clinical stage biopharmaceutical company, which specialises in developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. The Company has a lead antibiotic candidate, iclaprim, in clinical development and MTF-001, a preclinical stage programme to design a best-in-class dihydrofolate reductase inhibitor (DHFRi).

Iclaprim is being developed for the treatment of the most common and serious bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including those caused by resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae) that have become prevalent in patients in both the community and hospital settings.

This information is provided by RNS

The company news service from the London Stock Exchange

END

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