TIDMMTFB TIDMAMP

RNS Number : 8174T

Motif Bio PLC

22 July 2015

22 July 2015

Motif Bio plc

("Motif" or the "Company")

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

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 acute bacterial skin and skin structure infections (ABSSSI).

The Company requested QIDP designation for iclaprim for two serious and life threatening infections, hospital acquired bacterial pneumonia (HABP) and ABSSSI. QIDP designation has already been confirmed for HABP.

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. With QIDP designation, iclaprim is now 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.

Graham Lumsden, CEO of Motif Bio plc, said:

"QIDP designation for iclaprim has now been confirmed for the two serious and life threatening infections that we applied for. This is an important value driver for iclaprim and another positive development for Motif and our investors. We believe that iclaprim is the first and only dihydrofolate reductase inhibitor to receive the QIDP designation."

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 Treacy 
  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

STASEAFIEFISEEW

Amphion Innovations (LSE:AMP)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more Amphion Innovations Charts.
Amphion Innovations (LSE:AMP)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more Amphion Innovations Charts.