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.