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Nabriva Corporate
  • Home
  • About Nabriva
    • Our Products
    • Named Patient Program
    • Meet the Team
  • pipeline & research
    • Fosfomycin
    • pleuromutilins
  • For Investors
    • Events & Presentations
    • Press Releases
    • Financial Performance
    • Share Performance
    • Shareholder Information
    • Corporate Governance
  • News & Publications
  • careers
  • contact us

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.

image of immunoassay analyzer for research or drug development

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)

   
   
   
   
   
   

 

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© Nabriva Therapeutics plc, Ireland Registration No. 599588, 25-28 North Wall Quay, Dublin 1, Ireland

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© Nabriva Therapeutics plc, Ireland Registration No. 599588, 25-28 North Wall Quay, Dublin 1, Ireland