eyeownu
2年前
On July 30, 2023, the Company entered into an Asset Purchase Agreement with Sumitomo Pharma Co., Ltd., or Sumitomo, pursuant to which Sumitomo agreed to (i) purchase, among other things, the Company’s assets and rights related to the development, manufacture, marketing and commercialization of XENLETA in the People’s Republic of China, Hong Kong, Macau and Taiwan, or collectively the Territory, and (ii) assume certain liabilities related to the acquired assets. The transactions contemplated by the Asset Purchase Agreement closed on July 30, 2023. At the closing, Sumitomo made an upfront cash payment of $15.0 million, of which (i) $1.8 million was held back as security for potential indemnification claims, (ii) $10.4 million was paid by Sumitomo, on behalf of the Company, to certain of the Company’s contract manufacturing organizations to settle and discharge the remaining obligations under such agreements and (iii) $2.8 million was paid to the Company in cash. The cash received by the Company is not reflected on the balance sheet at June 30, 2023.
John-Knee
4年前
---- Nabriva Publishes Data Demonstrating the Potent Anti-Inflammatory Properties of XENLETA(R) (lefamulin)
2021-10-04 05:09:01 PM ET (GlobeNewswire)
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today published the first data to demonstrate the anti-inflammatory activity of XENLETA (lefamulin).
The nonclinical study, entitled "Anti-inflammatory activity of lefamulin versus azithromycin and dexamethasone in vivo and in vitro in a lipopolysaccharide-induced lung neutrophilia mouse model," was published in the peer-reviewed journal, PLOS ONE.
XENLETA is the first intravenous and oral pleuromutilin approved for the systemic treatment of community acquired bacterial pneumonia (CABP) in adults. In this nonclinical study of inflammatory lung disease, XENLETA potently inhibited inflammation caused by the migration of neutrophils (a type of white blood cell) in the lungs of mice. Importantly, XENLETA also reduced pro-inflammatory cytokines comparable to that observed with dexamethasone (a potent corticosteroid) and greater than that of azithromycin, a macrolide antibiotic commonly utilized for its anti-inflammatory properties.
"Infection in the lung is associated with an acute inflammatory reaction that can complicate a patient's clinical course and make treatment more difficult," said Steve Gelone, Pharm.D., Nabriva's President and Chief Operating Officer, and a co-author of the study. "We believe an agent that combines potent antibacterial and anti-inflammatory properties may offer clinicians a differentiated treatment option for their patients. We look forward to continuing to evaluate XENLETA's ability to mitigate the inflammatory response and exploring its clinical applications."
"These findings are important as they suggest lefamulin has anti-inflammatory properties, along with its proven anti-infective activity," said Dr. Thomas File, Jr. MD, MSc, MACP, FIDSA, FCCP and Chair of the Infectious Disease Division at Summa Health. "The potential to address two serious problems - the bacterial infection and concurrent inflammation - with a single agent may offer patients with acute lung disorders a more convenient treatment option."
In this study, the anti-inflammatory effects of XENLETA were evaluated in a mouse model of lung inflammation induced by a toxin called lipopolysaccharide that simulates acute respiratory distress syndrome (ARDS) similar to that seen with SARS-CoV-2 infection. Single subcutaneous doses of lefamulin (10â?'140mg/kg) resulted in reductions of several measurements of inflammation: dose-dependent reductions of bronchoalveolar lavage fluid neutrophil cell counts, pro-inflammatory cytokine (TNF-α, IL-6, IL-29 1B, and GM-CSF), chemokine (CXCL-1, CXCL-2, and CCL-2), and MMP-9 levels that were comparable to or more potent than single oral/intraperitoneal dexamethasone (0.5/1mg/kg) or subcutaneous azithromycin (10â?'100mg/kg).
About XENLETA
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA's binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA included diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.XENLETA.com.
Indication and Important Safety Information
Indication
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Important Safety Information
CONTRAINDICATIONS
XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.
XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.
WARNINGS AND PRECAUTIONS
XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.
Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
ADVERSE REACTIONS
The most common adverse reactions (greater-than or equal to2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.
USE IN SPECIFIC POPULATIONS
In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.
Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.
Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.
Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.
XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.
To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information for XENLETA.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA(R) (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO(TM) (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO(R) (tedizolid phosphate) in the United States and certain of its territories.
John-Knee
4年前
Study Demonstrates Macrolide-Resistance in S. pneumoniae in the United States Exceeds 25 Percent Threshold Set in Current Community-Acquired Bacterial Pneumonia (Cabp) Treatment Guidelines
February 23 2021 - 07:00AM
GlobeNewswire Inc.
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced the publication of a study documenting the high rates of macrolide-resistant Streptococcus pneumoniae throughout the United States. The study entitled, A Multicenter Evaluation of the Prevalence and Regional Variation in Macrolide Resistant S. pneumoniae in Ambulatory and Hospitalized Adult Patients in the U.S. was published this month in Open Forum Infectious Diseases (OFID), and demonstrated that macrolide resistance in S. pneumoniae is greater than 25 percent in most regions of the country and 39.5 percent overall. An accompanying editorial, authored by Daniel Musher, M.D., was also published in same issue of OFID.
The retrospective cohort study assessed 3,626 patients with a positive S. pneumoniae blood or respiratory culture evaluated between October 2018 and September 2019 at 329 hospitals in the BD Insights Research Database (Becton, Dickinson and Company, Franklin Lakes, NJ, US) across nine U.S. Census geographic regions. Macrolide resistance was observed in 47.3 percent of S. pneumoniae obtained from respiratory cultures, and 29.6 percent from blood cultures. While the overall rate of macrolide resistance was 39.5 percent, macrolide resistance in respiratory isolates was ≥25% in all regions of the U.S. In addition, higher rates of macrolide resistance were seen among ambulatory patients (45.3 percent) as compared with inpatients (37.8 percent).
Macrolide-resistant S. pneumoniae is designated as a serious public health threat according to the Centers for Disease Control and Prevention (CDC). S. pneumoniae is the leading cause of community-acquired bacterial pneumonia (CABP), a lung infection and the most common type of pneumonia that occurs outside of hospitals or other health care facilities. According to the CDC, S. pneumoniae causes 900,000 infections and 3,600 deaths annually. Joint guidance from the Infectious Diseases Society of America (IDSA)/American Thoracic Society (ATS) for the treatment of CABP recommend that macrolide antibiotics only be used if local pneumococcal resistance is less than 25 percent.
“The high rates of macrolide-resistant S. pneumoniae throughout the United States is the latest in mounting evidence for the need to combat the public health risks of antibiotic resistance,” said Kalvin C. Yu, MD, FIDSA and Medical Director at Becton Dickinson and Company. “Indiscriminate use of macrolides for viral conditions has been highlighted during COVID-19; the corollary here is clinicians now need to consider alternatives to macrolide monotherapy for suspected community-acquired pneumonia.”
“The findings from this study demonstrate the importance of contemporary, local epidemiology data to optimize the selection of empiric therapy for patients with CABP in accordance with 2019 guidelines issued by the IDSA/ATS,” said Jennifer Schranz, MD, Chief Medical Officer at Nabriva. “Based on current treatment guidelines, clinicians should consider alternatives to macrolide monotherapy for community-acquired pneumonia in the U.S. The study results also underscore the urgent need for innovative antibacterial agents with a novel mechanism of action against drug-resistant S. pneumoniae that offer a short-course, monotherapy treatment option.”
The full results of the study and related editorial commentary - Macrolides as empiric therapy for outpatients with pneumonia – are available online at OFID.
About XENLETA®
XENLETA is a first-in-class systemic pleuromutilin antibiotic for the intravenous (IV) and oral treatment of CABP in adults. XENLETA offers an effective and well tolerated empiric monotherapy for CABP with a treatment duration as short as five days and the potential to address the limitations of existing agents.
XENLETA has a novel mechanism of action that targets a binding site on bacteria that is different from existing antibiotics. It has been shown to result in no cross resistance to other antibiotic classes commonly prescribed for CABP and a low potential for the development of resistance. XENLETA is also convenient for patients being treated in the hospital, transitioning treatment out of the hospital or initiating treatment in the community.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.
John-Knee
4年前
Nabriva Therapeutics to Report Third Quarter 2020 Financial Results on November 5, 2020
2020-11-02 04:02:21 PM ET (GlobeNewswire)
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it will report its third quarter financial results after the close of the U.S. financial markets on Thursday, November 5, 2020. Nabriva's management will host a conference call at 4:30 p.m. ET to discuss the financial results and recent corporate highlights.
The dial-in number for the conference call is 866-811-8671 for domestic participants and 409-981-0874 for international participants, with Conference ID #5564729. A live webcast of the conference call can be accessed through the "Investors" tab on the Nabriva Therapeutics website at www.nabriva.com. A replay will be available on this website shortly after conclusion of the event for 90 days.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing Contepo(TM) (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO (tedizolid phosphate) in the United States and certain of its territories. For more information, please visit https://www.nabriva.com.
John-Knee
4年前
Nabriva Therapeutics to Report Third Quarter 2020 Financial Results on November 5, 2020
2020-11-02 04:02:21 PM ET (GlobeNewswire)
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that it will report its third quarter financial results after the close of the U.S. financial markets on Thursday, November 5, 2020. Nabriva's management will host a conference call at 4:30 p.m. ET to discuss the financial results and recent corporate highlights.
The dial-in number for the conference call is 866-811-8671 for domestic participants and 409-981-0874 for international participants, with Conference ID #5564729. A live webcast of the conference call can be accessed through the "Investors" tab on the Nabriva Therapeutics website at www.nabriva.com. A replay will be available on this website shortly after conclusion of the event for 90 days.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing Contepo(TM) (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO (tedizolid phosphate) in the United States and certain of its territories. For more information, please visit https://www.nabriva.com.
John-Knee
5年前
News: Nabriva's XENLETA Demonstrates High Efficacy in Patients of Advanced Age with Community-Acquired Bacterial Pneumonia (CABP)
2020-10-13 07:00:13 AM ET (GlobeNewswire)
-- Findings underscore potential of XENLETA as a first-in-class pleuromutilin antibiotic for the IV and oral treatment of CABP in adults, including older patients with comorbidities who are at risk of poor outcomes --
-- Pooled analysis of data by age group from pivotal LEAP 1 and LEAP 2 Phase 3 clinical trials to be presented at CHEST Annual Meeting 2020 --
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that in a post-hoc analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 trials by age, XENLETA(TM) (lefamulin) demonstrated consistently high efficacy and similar safety and tolerability profiles across all patient groups, including adults over 65 years of age who are at higher risk of morbidity and mortality from CABP. CABP is the most common cause of infectious death in U.S. adults age 65 and older. Results of the pooled analysis from the pivotal Phase 3 clinical trials of XENLETA will be presented at the virtual CHEST Annual Meeting, October 18-21, 2020.
"People of advanced age are especially at risk for developing CABP as a result of a weakened immune system and age-related comorbidities that increases the chances of hospitalization and CABP-related complications leading to functional impairment and/or mortality," said Jennifer Schranz, MD, Chief Medical Officer of Nabriva. "Our post-hoc analysis highlights that XENLETA provides a safe and effective empiric monotherapy alternative to fluoroquinolones for treatment of CABP in patients with advanced age and comorbidities."
In this pooled analysis of 1289 patients from LEAP 1 and LEAP 2 by age group, including adults ages 18-64, 65-74, 75-84, and 85 and older, 40 percent of the overall pooled patient population was over 65 years of age. Compared to younger patients, patients 65 years of age and older had higher pneumonia severity scores and were more likely to have renal impairment, cardiac disease, hypertension, diabetes or asthma/COPD. The analysis showed that early clinical response (ECR) and investigator assessment of clinical response (IACR) at the Test of Cure (TOC) for XENLETA were high (approximately 90%) and similar to that of moxifloxacin, a current standard of care fluoroquinolone for CABP, for all age groups. The adverse event profile and study drug discontinuation rates were similar across all age groups.
XENLETA is a first-in-class systemic pleuromutilin antibiotic with a unique mechanism of action that attacks the difficult-to-treat pathogens in CABP and addresses the challenges of antibiotic resistance. It is approved by the FDA for the IV and oral treatment of CABP in adults. Full results of the pooled analyses presented at the virtual CHEST Annual Meeting can be found here: https://www.nabriva.com/Portals/0/Nabriva/Posters/CHEST2020/LEF3067_CHEST%202020%20ePoster_LEAP%201%202%20Efficacy%20Safety%20by%20Age.pdf
About CABP
Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. There are approximately five million cases of pneumonia in the U.S. each year, and pneumonia is the fifth leading cause of hospitalization and one of the leading causes of infection-related death. Streptococcus pneumoniae is the most common cause of bacterial pneumonia in the U.S. According to recent data from the SENTRY Antimicrobial Surveillance Program, in the U.S., approximately 30 to 60 percent of S. pneumoniae, depending on region, are macrolide resistant. In addition to macrolides, fluoroquinolones are another common treatment option for CABP. This broad-spectrum class is an effective option; however, fluoroquinolones carry boxed warnings for several significant safety concerns.
About XENLETA
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA's binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more informatio n, please visit www.xenleta.com.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing Contepo(TM) (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO (tedizolid phosphate) in the United States and certain of its territories. For more information, please visit https://www.nabriva.com.
John-Knee
5年前
Nabriva Therapeutics Granted New Technology Add-On Payment for XENLETA(R) (lefamulin) and CONTEPO(TM) (fosfomycin) by Centers for Medicare & Medicaid Services
2020-09-10 08:39:22 AM ET (GlobeNewswire)
-NTAP designation highlights need for novel antibiotics to fight drug-resistant infections and advance antimicrobial stewardship
-CONTEPO first Qualified Infectious Disease Product to receive NTAP conditional approval prior to FDA approval
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for XENLETA (lefamulin) for injection when administered in the hospital inpatient setting. XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP). Both the IV and oral formulations of XENLETA were granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the FDA.
Beginning on October 1, 2020, CMS will provide an additional maximum payment of $1,275.75 for XENLETA when used in the inpatient hospital setting for fiscal year 2021. The U.S. Food and Drug Administration (FDA) approved the IV and oral versions of XENLETA for the treatment of adult patients with CABP in August 2019.
Nabriva also announced today that CMS has granted an NTAP for CONTEPO (fosfomycin), making CONTEPO the first QIDP to be granted conditional NTAP approval prior to receiving FDA approval. CONTEPO was granted QIDP and Fast Track Designation by the FDA for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. If CONTEPO receives FDA approval prior to July 1, 2021, the maximum add-on payment for a case involving the administration of CONTEPO is $2,343.75 for fiscal year 2021, which would become effective beginning in the first quarter after FDA approval is granted.
The NTAP will provide hospitals with a payment on top of the standard-of-care Diagnostic Related Group (DRG) reimbursement. This additional payment is provided to offset some of the costs of new drugs and devices when certain criteria are met. For the fiscal year 2021, add-on payments for QIDPs are limited to the lesser of 75 percent of the average cost of the product, or 75 percent of the amount by which the costs of the case exceeds the standard DRG payment. NTAP designation lasts no more than three years for a specific indication.
"The NTAP designation highlights the potential of XENLETA and CONTEPO to address the urgent need for novel, first-in-class antibiotics for patients fighting drug-resistant infections," said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. "Importantly, the decision to grant conditional NTAP approval to CONTEPO is unprecedented and we believe should enable more rapid access to this innovative antimicrobial following FDA approval. We applaud CMS for taking the initial policy steps that will enable patients in need to be prescribed innovative antibacterial agents and help reverse the consequences of antimicrobial resistance."
The NTAP program for antimicrobial resistance (AMR) is intended to encourage the use of new medical technologies in the hospital inpatient setting and help reduce barriers to antibiotic innovation.
About XENLETA
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA's binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting.
About CONTEPO
CONTEPO (fosfomycin) for injection 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 extended spectrum B-lactamase (ESBL)-producing Enterobacteriaceae. IV fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections.
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