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Motif Bio Reports Half-Year 2018 Financial Results and Operational ProgressNEW YORK, Sept. 25, 2018 (GLOBE NEWSWIRE) -- NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART DIRECTLY OR INDIRECTLY IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION. Motif Bio plc (AIM/NASDAQ: MTFB) (“Motif Bio”, or “the Group”), a clinical-stage biopharmaceutical company specializing in developing novel antibiotics, today announced unaudited financial results for the half year ended June 30, 2018 and reported on its progress year to date. Graham Lumsden, CEO of Motif Bio, said: “We made tremendous progress during the first half of 2018, including completing the submission of an NDA with the U.S. FDA for iclaprim in acute bacterial skin and skin structure infections, which was accepted for review in August with confirmation of a Priority Review from FDA resulting in a PDUFA date of February 13, 2019. We are continuing to build on our achievements and are working to increase awareness and understanding of Motif Bio and iclaprim with potential commercialization partners, the medical community and investors. As partnering discussions progress, we continue to evaluate ways to build a team of Medical Science Liaisons, Key Account Managers and Professional Representatives to be able to deliver iclaprim to patients in an effective and efficient manner. Our primary focus is ensuring a successful launch and commercialization in the first half of 2019, assuming that iclaprim is approved for marketing by the FDA.” Corporate and Development Highlights – 2018 Year to Date:
Financial Highlights
Motif Bio’s interim financial results for the six months ended June 30, 2018 are available on its website (www.motifbio.com) in the Investors section. For further information, please contact:
About Motif Bio Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage biopharmaceutical company focused on developing novel antibiotics for hospitalized patients and designed to be effective against serious and life-threatening infections caused by multi-drug resistant Gram-positive bacteria, including MRSA. The Company’s lead product candidate is iclaprim. Following positive results from two Phase 3 trials (REVIVE-1 and REVIVE-2), a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is now under review, with a PDUFA date of February 13, 2019. More than 3.6 million patients with ABSSSI are hospitalized annually in the U.S. It is estimated that up to 26% of hospitalized ABSSSI patients have renal impairment. The Company also plans to develop iclaprim for hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), as there is a high unmet need for new therapies in this indication. A Phase 2 trial in patients with HABP has been successfully completed and a Phase 3 trial is being planned. Additionally, iclaprim has been granted orphan drug designation by the FDA for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis and is in preclinical development for this indication. Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track status for the ABSSSI indication. If approved for the ABSSSI indication as a New Chemical Entity, iclaprim will be eligible for 10 years of market exclusivity in the U.S. from the date of first approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act). In Europe, 10 years of market exclusivity is anticipated. Motif is building a patent estate to provide additional protection for iclaprim. On August 8, 2018 the Company announced that it had received a Notice of Allowance from the United States Patent and Trademark Office for United States Patent Application Nos. 15/586,021 and 15/586,815. The claims relate to the use of iclaprim to treat patients with bacterial infections, including but not limited to acute bacterial skin and skin structure infections, hospital-acquired bacterial pneumonia and Staphylococcus aureus lung infections in patients with cystic fibrosis. The two method of use patents will expire in November 2037. Other patent applications have been and are expected to be filed that are designed to protect our proprietary technologies, including processes for manufacturing the iclaprim active pharmaceutical ingredient and therapeutic formulations, their use in pharmaceutical preparations and methods of treating disease with iclaprim. Forward-Looking Statements This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled “Risk Factors” in Motif Bio’s Annual Report on Form 20-F filed with the SEC on April 10, 2018, which is available on the SEC’s web site, www.sec.gov. Motif Bio undertakes no obligation to update or revise any forward-looking statements. |