|OK TEAM...Here is NEWS that all the analyst have been waiting for! |
I urge you to look back at the chart for the big spikes that came on each Data release..
*Nabriva Therapeutics Completes Submission of New Drug Application to U.S. FDA for Intravenous CONTEPO
PRESS RELEASE GlobeNewswire
Nov. 1, 2018, 07:00 AM
DUBLIN, Ireland, Nov. 01, 2018 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to seek marketing approval for its investigational intravenous antibiotic, CONTEPO™ (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis. CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI, which enables Priority Review of the NDA, following acceptance.
“A significant medical need remains in the United States for new treatments for complicated urinary tract infections as serious Gram-negative infections caused by extended-spectrum beta-lactamase (ESBLs) producing Enterobacteriaceae, as well as other multi-drug resistant pathogens, continue to be a significant challenge for healthcare providers leading to treatment failure, infection recurrence, re-hospitalizations, and higher rates of morbidity and mortality,” said Dr. Jennifer Schranz, chief medical officer of Nabriva Therapeutics. “Therapies with a new mechanism of action are desperately needed to address this growing public health threat. This NDA submission represents a substantial achievement for our company. We are truly grateful to the patients, investigators, and the entire team for their commitment to advancing CONTEPO to this important milestone. We look forward to working with the FDA during the review process with the goal of bringing CONTEPO, a potentially first-in-class intravenous antibiotic, to clinicians and patients.”
The NDA submission is utilizing the 505(b)(2) regulatory pathway and is supported by a robust data package, including a pivotal Phase 2/3 clinical trial (known as ZEUS™), which met its primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with cUTI, including acute pyelonephritis.
Urinary tract infections (UTIs) are a significant health problem in both the community- and hospital-based treatment settings. It is estimated that 150 million UTIs occur yearly worldwide, accounting for $6 billion in health care expenditures, according to the American Urological Association. Patients who fail to respond to an initial course of antibiotics can go on to develop a cUTI, which occurs when the bacteria are embedded in the bladder wall where they can multiply more slowly and are much harder to address with antibiotics. In most cases, cUTIs occur following treatment for a normal UTI because antibiotics were given too late, for too short a period of time, at too low of a dose course or the wrong antibiotic was used and did not provide adequate spectrum of coverage. An estimated three million cases of cUTIs are treated in the hospital setting in the United States each year for Gram-negative infections. Enterobacteriaceae are the most common pathogens causing cUTIs and, currently, widespread antibiotic resistance limits the effective treatment options for cUTI. Ineffectively managed cUTI can lead to increased treatment failure rates, recurrence of infection, increased re-hospitalization, and increased morbidity and mortality.
CONTEPO™ (fosfomycin for injection, previously referred to as ZTI-01 and ZOLYD) is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as ESBL-producing Enterobacteriaceae. Intravenous (I.V.) fosfomycin has been approved for a number of indications and utilized for over 45 years in Europe to treat a variety of infections, including cUTIs and other serious bacterial infections. CONTEPO utilizes a new dosing approach, originally developed by Zavante (which Nabriva Therapeutics acquired), to optimize its pharmacokinetics and pharmacodynamics. Nabriva Therapeutics believes these attributes, along with the positive clinical experience worldwide, support CONTEPO as a first-line treatment for cUTIs, including acute pyelonephritis, suspected to be caused by MDR pathogens. At least 20 percent of cUTIs are caused by MDR bacteria and limited treatment options are available in the U.S. In addition, non-clinical data have shown that CONTEPO acts in combination with certain other antibiotics to improve bacterial killing.