| Name | Title | Contact Details |
|---|---|---|
Shanmugasundaram Sathish |
VP, Digital and Enterprise Applications | Profile |
Marjorie Nehring |
Associate Director of Information Technology - Quality and Manufacturing Applications | Profile |
Nabriva is a clinical-stage biopharmaceutical company engaged in the research and development of novel antibiotics to treat serious infections, with a focus on the pleuromutilin class of antibiotics. Our goal is to become a fully integrated biopharmaceutical company focused on the research, development and commercialization of novel anti-infective products. Nabriva was incorporated as a spin-off from Sandoz GmbH Antibiotics Research Institute (ABRI) in Vienna, Austria and commenced operations in February 2006. The new organization included small molecule assets, including pleuromutilin structure activity relationships (SAR) knowledge and was focused on synthesis of pleuromutilins for systemic human use. Following identification of our lead compound lefamulin and based on the clinical results of lefamulin 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. In 2014, we opened our US office in King of Prussia, Pennsylvania and completed an IPO on the NASDAQ under the ticker NBRV in September 2015. With net proceeds from our IPO, we initiated two global, registrational Phase 3 clinical trials of lefamulin for the treatment of moderate to severe CABP. Based on our estimates regarding patient enrollment, we expect to have top-line data available for both trials in the second half of 2017. If the results of these trials are favorable, including achievement of the primary efficacy endpoints of the trials, we expect to submit applications for marketing approval for lefamulin for the treatment of CABP in both the United States and Europe in 2018. As of April 1, 2016, Nabriva employed 52 employees at its headquarters in Vienna, Austria, and its office in King of Prussia, Pennsylvania, United States.
MANUFACTURING Philosophy The TRC team understands that the actions required to be a successful pharmaceutical manufacturer are more than just completing repetitive and highly detailed tasks accurately; it is the understanding that we...
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