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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.
Accumulus Synergy is a global, non-profit organization that is developing a transformative data exchange platform that aims to enable enhanced collaboration and efficiency between life sciences organizations and global health authorities, while also affording users the ability to extract dynamic, data-driven insights from knowledge management. Sponsored by leading biopharmaceutical companies, Accumulus Synergy was formed in 2020 to create innovative solutions that can reduce regulatory review times and transform global data exchange. The non-profit company is creating a first-of-its-kind cloud-based platform between the biopharmaceutical industry and health authorities worldwide. The single-platform approach aims to improve speed, transparencies and efficiencies in the regulatory process by leveraging advanced technology and tools for data exchange. This will help reduce the cost of innovation and ultimately bring patients safe and effective medicines faster.
Cosette Pharmaceuticals is a US based, diversified pharmaceutical company with a proven topicals and dermatology portfolio and a growing branded pharmaceuticals business. We are fully integrated, with a deep focus on internal R&D, high quality manufacturing standards and commercial sales excellence. We continue to diversify and expand through strategic partnerships, acquisitions and internal R&D. Our highly experienced leadership team are busy writing the next, most ambitious chapter of our story. Building on a 100+ year heritage, their shared vision of innovation will leverage the expertise of more than 350+ team members, and infrastructure to create remarkable new opportunities for the patients and physicians we serve every day.
Medical Center Compounding is a Cleveland, TN-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Kamada is focused on plasma-derived protein therapeutics with a commercial product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived Immune globulins. AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company`s flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets GLASSIA® in the U.S. through a strategic partnership with Baxalta (now part of Shire plc) and in other counties through local distributors. In addition to GLASSIA®, Kamada has a product line of six other pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. Kamada`s rabies immune globulin (Human) product received FDA approval for Post-Exposure Prophylaxis against rabies infection and is marketed in the U.S. through a partnership with Kedrion Biopharma. Kamada has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency and, in addition, its intravenous AAT is in development for other indications, such as type-1 diabetes, GvHD and prevention of lung transplant rejection. Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 10 complementary products in Israel that are manufactured by third parties.