Lefamulin Acetate

CHICAGO--( BUSINESS WIRE )--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago focused on the development and commercialization of generic, fertility, biologic, and branded injectable products, announced it has secured exclusive commercial rights in the U.S. to XENLETA ® (lefamulin acetate) through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industrial Co., Ltd. (HKF). XENLETA ® belongs to a new class of novel antibiotics and is approved in intravenous and oral formulations in the U.S. and multiple other countries for the treatment of community-acquired bacterial pneumonia (CABP) in adults. HKF has acquired global rights to XENLETA ® (with the exception of Greater China) from Nabriva Therapeutics. Through the acquisition, HKF has obtained substantially all global assets related to XENLETA ® , including results of development and regulatory activities. “The licensing of XENLETA ® bolsters our portfolio of novel antibiotics and reflects our focus on addressing the growing issue of antimicrobial resistance,” said Tom Shea, Chief Executive Officer of Meitheal. “As the first approved medicine of an entirely new class of antibiotics, XENLETA ® is an innovative therapeutic option that will be available to the patients affected by CABP and has been shown to be active against various bacterial strains. We look forward to leveraging our end-to-end expertise in biopharmaceutical development and commercialization to bring this important therapeutic to patients in need.” XENLETA ® is a first-in-class semi-synthetic pleuromutilin antibiotic. As a monotherapy offering a complete spectrum of coverage for the main CABP pathogens and with a low propensity for the development of bacterial resistance, XENLETA ® represents a critical step in addressing the growing global public health crisis of antimicrobial resistance (AMR) and supports the principles of antimicrobial stewardship. “Antimicrobial resistance, unfortunately, undermines the treatment paradigms of many infectious diseases globally, leading to poor patient outcomes and increased costs to healthcare systems,” said Brett Novak, Meitheal’s Senior Vice President of Commercial Operations. “XENLETA ® provides a unique and well-tolerated product profile for the more than five million annual cases of CABP in the U.S., where it has the potential to serve as a first-line monotherapy option in both the inpatient and outpatient settings. We are pleased that this agreement will allow us to unlock synergies with our existing franchises and deliver critical medicines that address large gaps in the antibiotic treatment landscape.” Global approvals of XENLETA ® in CABP are based on the results of two global, pivotal Phase 3 trials, LEAP 1 and LEAP 2, in which XENLETA ® met all primary endpoints. Meitheal recently added the first anti-infective to its portfolio through an exclusive commercialization agreement with HKF—CONTEPO™. Meitheal will leverage its new aligned-to-CONTEPO ™ marketing, sales, and medical science liaison teams to support the launch of XENLETA ® , which shares similar hospital call points. Meitheal will further establish practice-based support for key prescribers and patients that could benefit from XENLETA ® . “We are pleased to have acquired the rights to XENLETA ® and look forward to supporting Meitheal as it delivers this important medication to patients in the U.S.,” said Eric Tang, President of HKF. “We are committed to supporting Meitheal’s work to deliver accessible, sustainable, and innovative healthcare solutions and we remain focused on continuing to invest in the research, development, and commercialization of branded pharmaceuticals to achieve this goal.” HKF and its related entities have invested over $300 million in capital and research and development in recent years to support sustainable product supply across key focus areas, including branded biopharmaceuticals. The licensing agreement for XENLETA ® adds a third branded biopharmaceutical and first on-market branded product to Meitheal’s portfolio. ABOUT COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA (CABP) Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. CABP is among the most common types of pneumonia, with five million cases in the U.S. each year. 1 In the U.S., CABP is the leading cause of infection-related death 2 and the fourth leading cause of hospitalization, 3 a setting where mortality rates are approximately 15% 4 . Certain bacteria that cause CABP have become resistant to one common antibiotic, macrolides, at a rate on average of 50%. 5 The U.S. FDA has also issued multiple warnings about the resistance of one current class of CABP treatments called fluoroquinolones. 6 Antimicrobial resistance (AMR) is a top global public health threat that creates challenges treating infections and performing medical procedures and increases the risk of death and disability. 7 Novel antibiotics that kill bacteria, including those that cause CABP, in a different way are essential to addressing AMR. 8 ABOUT XENLETA ® XENLETA ® (lefamulin acetate) is a first-in-class, semi-synthetic pleuromutilin antibiotic for systemic administration in humans. 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. Two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP demonstrated XENLETA ® ’s efficacy. 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. CONTRAINDICATIONS XENLETA ® is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA ® . Concomitant use of XENLETA ® tablets with CYP3A substrates that prolong the QT interval is contraindicated. WARNINGS AND PRECAUTIONS QT Prolongation: Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents. Embryo-Fetal Toxicity: 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: Evaluate patients who develop diarrhea. ADVERSE REACTIONS The most common adverse reactions associated with XENLETA ® Injection include administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia and headache. The most common adverse reactions associated with XENLETA ® Tablets include diarrhea, nausea, vomiting, hepatic enzyme elevation. Please see Full Prescribing Information for more information. ABOUT MEITHEAL PHARMACEUTICALS, INC. Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of October 2024, Meitheal, directly or through its partners, has 18 products in the research and development phase, 6 additional products planned for launch in 2024, and 21 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly-priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good. Learn more about who we are and what we do at www.meithealpharma.com . ABOUT HONG KONG KING-FRIEND INDUSTRIAL COMPANY (HKF) Hong Kong King-Friend Industrial Company is a wholly owned subsidiary of Nanjing King-Friend Biochemical Pharmaceutical Company, founded in 2010. ABOUT NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL COMPANY (NKF) Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of the world’s leading manufacturers of heparin-related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA-approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. NKF is publicly listed on the Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion. 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. FDA approval for XENLETA ® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics also previously developed CONTEPO™ (fosfomycin for injection), a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI). ___________________________ 1 National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) 2009 -2010. https://archive.cdc.gov/#/details?url=https://www.cdc.gov/nchs/data/ahcd/combined_tables/2009-2010_combined_web_table01.pdf (Last Accessed December 4, 2024). 2 el Bcheraoui C, Mokdad AH, Dwyer-Lindgren L, et al. Trends and Patterns of Differences in Infectious Disease Mortality Among US Counties, 1980-2014. JAMA.2018;319(12):1248–1260. doi:10.1001/jama.2018.2089. 3 McDermott KW, Roemer M. Most frequent principal diagnoses for inpatient stays in U.S. Hospitals, 2018: Statistical Brief, no 277. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, MD: Agency for Healthcare Research and Quality. 2021. https://hcup-us.ahrq.gov/reports/statbriefs/sb277-Top-Reasons-Hospital-Stays-2018.pdf . 4 2017 CHARTBOOK STATIC ANALYSES -Trends in mortality rates following admission for acute myocardial infarction, chronic obstructive pulmonary disease, heart failure, pneumonia, and acute ischemic stroke. Prepared for CMS by Yale New Haven Health Services Corporation -Center for Outcomes Research and Evaluation (YNHHSC/CORE) September 2017. 5 Classi P, Landsman-Blumberg P, Carroll C, et al. The relationship between macrolide-resistant streptococcus pneumoniae and treatment failure in adults with community-acquired pneumonia by CDC region in the United States. Abstract J03. In: Meeting abstracts, Academy of Managed Care Pharmacy Nexus 2016; October 3-6, 2016; National Harbor, MD. 6 Food and Drug Administration. FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions. https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-fluoroquinolone-antibiotics-risks-mental-health-and-low-blood-sugar-adverse . Accessed December 4, 2024. 7 World Health Organization. Antimicrobial resistance. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance . Accessed December 4, 2024. 8 Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2013, US Department of Health and Human Services.

Elevation Oncology's workforce shake-up didn’t stop at the boardroom door, with CEO Shawn Leland also departing. If last year was marred by continual stories of biotechs laying off staff and pruning back their pipelines to survive, then this week’s news suggests the new year hasn’t quite brought the fresh start the industry was hoping for. In a postmarket announcement yesterday, cell-therapy-focused Century Therapeutics announced it is de-prioritizing investment in CNTY-103, a CD133-targeting, chimeric antigen receptor, iPSC-derived NK (CAR-iNK) cell therapy candidate in preclinical development for glioblastoma. A discovery program for hematologic malignancies will also be discarded. Instead, the biotech will focus on its lead product CNTY-101, a CD19-targeting allogeneic cell therapy in phase 1 trials for relapsed/refractory B-cell lymphoma as well as a pair of gamma delta T-cell therapy candidates in preclinical development for B-cell malignancies and solid tumors. The reprioritization will allow the company to close its lab operations in Seattle and Hamilton, with research work consolidated in Philadelphia. While it means a quarter of the company’s workforce will be heading to the exits, the biotech explained that this will give it a cash runway of at least three years. The staffing shake-up even extended to the top ranks of the company, with R&D chief Hy Levitsky, M.D., Ph.D., resigning effective the end of the month. “As our confidence in the disruptive potential of our technology platform and prioritized pipeline programs continues to increase, we have implemented these cost-saving measures to rightsize the organization and further extend our cash runway to enable achievement of key milestones,” CEO Lalo Flores, Ph.D., said in a release. “As a result, we are losing many valued colleagues, which is an incredibly difficult decision, and we would like to thank each of them for their contributions.” It was a similar story at Elevation Oncology, which announced this morning that it was pausing investment in seribantumab. The fully human IgG2 monoclonal antibody, which is designed to bind to human epidermal growth factor receptor 3, had been on course to deliver further interim data from its phase 2 study in patients with solid tumors harboring NRG1 gene fusions. The company touted initial findings from the trial at the 2022 American Society of Clinical Oncology annual meeting as showing positive clinical proof-of-concept data. But now, the biotech has shelved the antibody unless or until a partner is found. Elevation’s focus will be on EO-3021, an antibody-drug conjugate targeting Claudin18.2 that’s entered phase 1 trials for solid tumors. Elevation acquired the ex-China rights to the drug from CSPC Megalith Biopharmaceutical for $27 million in July. Unfortunately, it’s a journey that 30% of Elevation’s existing workforce will no longer be required for. Again, the workforce shake-up didn’t stop at the boardroom door, with CEO Shawn Leland also departing. The situation was terminal for Nabriva Therapeutics, which has now shut shop entirely. The Irish biotech had already resorted to laying off 40% of staff and suspending its early-stage R&D projects in November. But the commercial refocus wasn’t enough to stay afloat, and the company announced this morning that it’s winding down operations as it looks for a buyer for its marketed assets like the antibiotic Xenleta. This latest spate of news caps off a couple of days that also saw Fate Therapeutics announce a raft of changes including layoffs, pipeline culls and ending a Johnson & Johnson collaboration. Meanwhile, Graphite Bio threatened “operational efficiencies to extend its cash position” after the first patient dosed with its lead gene therapy candidate experienced a serious adverse event.