NBRV Nabriva Therapeutics PLC

Nabriva Therapeutics plc (NASDAQ:NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today announced that it will showcase data at ID Week 2017 taking place from October 4-8 in San Diego, California.

At the meeting, three presentations will feature the company’s most advanced pleuromutilin antibiotic, known as lefamulin. Earlier this month, Nabriva Therapeutics announced positive topline results from the first of two Phase 3 clinical trials in adults with community-acquired bacterial phenomena (CABP), known as LEAP 1.

“Resistance to current, gold standard, antibiotic therapies continues to grow and patients desperately need new therapies that possess a novel mechanism of action that result in potent activity against resistant pathogens, while minimizing the collateral damage often observed from broad spectrum antibacterial agents,” said Steven P. Gelone, Pharm.D., chief scientific officer at Nabriva Therapeutics. “These data add to the growing evidence supporting lefamulin’s targeted spectrum of activity against the pathogens most commonly associated with CABP, including multi-drug resistant strains.”

In addition, Dr. Gelone will deliver a presentation on lefamulin and participate in a panel focused on new antibiotic agents in development. 

Nabriva Therapeutics is hosting a Corporate Reception for ID Week attendees at the San Diego Marriott Gaslamp Quarter Altitude Sky Lounge, 22nd Floor on Thursday, October 5, 2017 from 7:00 p.m. – 9:30 p.m. To secure your attendance, please contact NabrivaEvents@HCAGroup.com by October 2, 2017.

Details of the sessions and data presentations at ID Week 2017 are as follows:

Thursday, October 5, 2017

• Symposium 088: New Antibiotics: What's in the Pipeline: Lefamulin  º Room: 20ABCD  º Session: Symposium: New Antibiotics: What's in the Pipeline  º Presenter: Steven P. Gelone, Pharm.D.  º Time: 2:45 p.m. PDT

Friday, October 6, 2017

• Session 107: Pipeline 2.0  º Room: 06DE  º Session: Meet-the-Professor  º Panelist: Steven P. Gelone, Pharm.D.  º Time: 7:00-8:15 a.m. PDT

•  Poster 1218: In Vitro Activity of Lefamulin against S. aureus Collected Worldwide from Hospitalized Patients with Bacterial Pneumonia  º Room: Poster Hall CD Session: Poster Abstract  º Session: Expanded Spectrum - New Antimicrobial Susceptibility Testing  º Presenter: Susanne Paukner, Ph.D.  º Time: 12:30-2:00 p.m. PDT

• Poster 1220: In Vitro Activity of Lefamulin Against a Global Collection of Bacterial Pathogens Commonly Causing Community-Acquired Bacterial Pneumonia (CABP, SENTRY 2015)  º Room: Poster Hall CD Session: Poster Abstract  º Session: Expanded Spectrum - New Antimicrobial Susceptibility Testing  º Presenter: Susanne Paukner, Ph.D.  º Time: 12:30-2:00 p.m. PDT
•  Abstract 1509: Efficacy of Lefamulin Against Staphylococcus aureus - Induced Bacteremia in a Neutropenic and Immunocompetent Murine Model  º Room: Poster Hall CD Session: Poster Abstract  º Session: Preclinical Study with New Antibiotics and Antifungals  º Presenter: Wolfgang W. Wicha, MSc  º Time: 12:30-2:00 p.m. PDT

About CABP

Based on Nabriva Therapeutics’ combined analysis of the U.S. Centers for Disease Control and Prevention’s 2007 National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey and 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that more than 5 million adults are treated annually for CABP in the United States. Additionally, based on 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that approximately 3.1 million of these adult CABP patients sought treatment in a hospital setting, where most are then treated with in-patient IV and oral antibiotics or out-patient oral antibiotics prescribed for use following hospital discharge or release.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the research and development of new medicines to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Nabriva Therapeutics’ medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations. Nabriva Therapeutics’ lead product candidate, lefamulin, is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The company believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade. Nabriva has announced positive topline data for lefamulin from the first of its two global, registrational Phase 3 clinical trials evaluating lefamulin in patients with moderate to severe community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics believes lefamulin is well-positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral and IV formulations and a favorable tolerability profile, with the results of the LEAP 1 trial showing a rate of treatment-emergent adverse events comparable to moxifloxacin with or without linezolid. Nabriva Therapeutics intends to further pursue development of lefamulin for additional indications, including the treatment of acute bacterial skin and skin structure infections (ABSSSI), and is developing a formulation of lefamulin appropriate for pediatric use.

Nabriva Therapeutics owns exclusive, worldwide rights to lefamulin, which is protected by composition of matter patents issued in the United States, Europe and Japan.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Nabriva, including but not limited to statements about the development of Nabriva’s product candidates, such as plans for the design, conduct and timelines of Nabriva’s ongoing Phase 3 clinical trial of lefamulin for CABP, the clinical utility of lefamulin for CABP and Nabriva’s plans for filing of regulatory approvals and efforts to bring lefamulin to market, the development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates, the sufficiency of Nabriva’s existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials, whether results of Nabriva’s first Phase 3 clinical trial of lefamulin will be indicative of the results for its second Phase 3 clinical trial of lefamulin, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption “Risk Factors” in Nabriva’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva’s views as of the date of this release. Nabriva anticipates that subsequent events and developments will cause its views to change. However, while Nabriva may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva’s views as of any date subsequent to the date of this release.

Contact:

INVESTORS Dave Garrett Nabriva Therapeutics plc david.garrett@nabriva.com 610-816-6657

MEDIA Katie Engleman Pure Communications katie@purecommunications.com 910-509-3977