News & Publications Careers Contact Us ABOUT NABRIVA PIPELINE & RESEARCH FOR INVESTORS ABOUT NABRIVA Home / About Nabriva Meeting the Demand for New Antibiotics Nabriva Therapeutics is committed to developing new antibiotics to treat infectious diseases. Our dedicated team includes people with extensive science and industry experience and a shared passion for addressing the increasingly urgent problem of bacterial resistance worldwide. Nabriva is a commercial-stage biopharmaceutical company with locations in the United States (Fort Washington, PA, San Diego, CA), Austria (Vienna), and Ireland (Dublin), home of our corporate headquarters. OUR FOCUS OUR STRATEGY CORPORATE HISTORY OUR PRODUCTS NAMED PATIENT PROGRAM Our Focus: Innovative Anti-Infectives Lefamulin, is the first pleuromutilin antibiotic for intravenous and oral administration in humans. We have completed two pivotal Phase 3 trials evaluating the safety and efficacy for the treatment of community-acquired bacterial pneumonia (CABP), the leading cause of infection death and the second most common cause of hospitalization in the United States. Lefamulin met all U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)primary endpoints in both LEAP 1 and LEAP 2 and was shown to be generally well tolerated. Both formulations of lefamulin were granted Qualified Infectious Disease Product and Fast Track designation by the FDA. On August 19, 2019, the FDA Approved Xenleta®(lefamulin) for both Oral and IV use. In March 2019, we entered into a license and commercialization agreement with Sunovion Pharmaceuticals Canada Inc. for Xenleta in Canada. In July 2020, our partner, Sunovion Pharmaceuticals Canada Inc., received approval for Xenleta®(lefamulin) from Health Canada for the treatment of community-acquired pneumonia (CAP) in adults. In May 2019, we submitted a marketing authorization application for both the IV and oral formulations of lefamulin, for the treatment of community-acquired pneumonia (CAP) in adults 18 years of age and older, to the EMA. On July 28, 2020, the EMA approved Xenleta®(lefamulin) for the treatment of community-acquired pneumonia (CAP) Nabriva intends to work with a commercial partner to make Xenleta®(lefamulin) available to patients in the European Union. In March 2018, we entered into a license agreement with Sinovant Sciences to develop and commercialize lefamulin in Greater China. Sinovant Science’s application to conduct a clinical trial of lefamulin (SNV001) in China was approved by China’s National Medical Products Administration and patient recruitment for the efficacy and safety study is ongoing. Through our research and development efforts, we have also identified a topical pleuromutilin product candidate, BC-7013, for which we have completed a Phase 1 clinical trial. We believe that this pleuromutilin compound is well suited for the topical treatment of a variety of Gram-positive infections, including uncomplicated skin and skin structure infections. CONTEPO™ (fosfomycin for injection) is a potentially first-in-class epoxide intravenous (“IV”) antibiotic in the United States with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against many contemporary multi-drug resistant (“MDR”) strains that threaten hospitalized patients. IV fosfomycin has an extensive commercial history in markets outside the United States, where it has been used broadly for over 45 years to treat a variety of indications, including complicated urinary tract infections, bacteremia, pneumonia and skin infections. In October 2018, Nabriva Therapeutics submitted a New Drug Application (NDA) to the FDA to seek marketing approval for CONTEPO™ to treat cUTIs, including acute pyelonephritis. On April 30, 2019, we received a Complete Response Letter (CRL) from the FDA for the NDA. The CRL requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the NDA. In December 2019, Nabriva resubmitted its New Drug Application (NDA) to the FDA for CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections(cUTIs), including acute pyelonephritis. On June 19, 2020, we received a Complete Response Letter (CRL) from the FDA for the NDA due to FDA’s inability to conduct onsite inspections because of travel restrictions. Nabriva plans to request a Type A meeting with the FDA to discuss appropriate next steps and the FDA’s plans for completing foreign facility inspections. Key Elements of Our Current Strategy for Success Our goal is to become a fully integrated biopharmaceutical company focused on the development and commercialization of new antibiotics and other novel anti-infective products. Evaluate business development opportunities and potential collaborations with other pharmaceutical or biotechnology companies Our Corporate History 2006 Nabriva was incorporated as a spin-off from Sandoz GmbH Antibiotics Research Institute (ABRI) in Vienna. The new organization included small molecule assets, including pleuromutilin structure activity relationships (SAR) knowledge, and focused on synthesis of pleuromutilins for systemic human use. 2007-2009 Following identification of our lead compound lefamulin and based on its clinical results for Acute Skin and Skin Structure Infections, we believed that targeted in vitro spectrum of activity for the common pathogens causing Community Acquired Bacterial Pneumonia (CABP) would allow us to develop lefamulin as the first pleuromutilin IV and oral antibiotic for human systemic administration for CABP. 2014 Opened our United States office in King of Prussia, Pennsylvania. 2015 Completed an IPO on the NASDAQ under the ticker NBRV. We initiated two global, registrational Phase 3 clinical trials of lefamulin for the treatment of moderate-to-severe CABP. 2017 In June, we redomiciled our corporate headquarters to Dublin, Ireland. 2018 Acquired Zavante Therapeutics and CONTEPO™, a potential first-in-class injectable antibiotic in the United States for cUTIs Submitted NDAs for CONTEPO to treat cUTIs, including acute pyelonephritis and lefamulin for the oral and IV formulations of lefamulin for the treatment of CABP. 2019 Submitted a marketing authorization application for both the IV and oral formulations of lefamulin, for the treatment of community-acquired pneumonia (CAP) in adults 18 years of age and older, to the European Medicines Agency. The FDA Approves Xenleta™(lefamulin) for both Oral And IV use. 2020 XENLETA® (lefamulin) receives approval in Europe and Canada for the treatment of community-acquired pneumonia (CAP). Nabriva enters into exclusive agreement with Merck & Co, Inc. to promote and distribute SIVEXTRO (tedizolid phosphate) in the United States. WEP Clinical partners with Nabriva for the Named Patient Supply of XENLETA® (lefamulin) Nabriva Response to COVID-19 Thank you to all the healthcare professionals for your tireless service on the frontlines of this pandemic. Due to COVID-19, the FDA has reported shortages of key drugs, including select antibiotics. Xenleta® (lefamulin) may be an alternative regimen for patients in need. Nabriva wants to reassure you that we have sufficient inventory of XENLETA IV and Oral tablets, available through designated specialty pharmacies or specialty distributors. Learn more at www.XENLETA.com. Again, to all the medical professionals, please be safe, take care of yourself and stay well. Best, Ted Schroeder CEO, Nabriva Therapeutics Continue to site Work With Us We’re looking for like-minded people who share our passion for innovation and mission to address serious infectious diseases. Explore Careers Meet Our Team We bring together a deep level of industry experience, scientific expertise, and heartfelt commitment to patients. Learn More Privacy Notice Patents Imprint Disclaimer Contact Us Careers Sitemap © Nabriva Therapeutics plc, Ireland Registration No. 599588, 25-28 North Wall Quay, Dublin 1, Ireland