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Shionogi to Present In Vitro and Real-World Data at IDWeek 2021 Demonstrating Activity of FETROJA® (cefiderocol) Against Gram-Negative Pathogens

September 28, 2021 Off By BusinessWire

OSAKA, Japan & FLORHAM PARK, N.J–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announces that 11 abstracts on FETROJA^® (cefiderocol) will be shared at IDWeek. The meeting will take place virtually from Sept. 29 – Oct. 3, 2021.

“The data presented at IDWeek underscores our commitment to fighting antimicrobial resistance and addressing the challenges in treating carbapenem-resistant Gram-negative bacteria, which are associated with high mortality and unmet need,” said Akira Kato, Ph.D., President and CEO at Shionogi Inc. “We look forward to sharing new real-world data on FETROJA with the infectious disease community at IDWeek.”

Presentations will include data from company-sponsored or investigator-initiated studies. Abstracts will be available in the IDWeek Interactive Program and include:

Poster #789: Susceptibility of Phenotypic Subsets of Pseudomonas aeruginosa isolates of Cefiderocol and Comparator Agents from SIDERO-WT 2014-2019

Presenter: Sean Nguyen, Pharm.D.

Poster #1058: In Vitro and in Vivo Antibacterial Activity of Cefiderocol against Burkholderia spp.

Presenter: Merime Ota, BSc

Poster #1065: Efficacy of Cefiderocol in Experimental Stenotrophomonas maltophilia Pneumonia in Persistently Neutropenic Rabbits

Presenter: Vidmantas Petraitis, M.D.

Poster #1066: In Vitro and in Vivo Antimicrobial Activity of Cefiderocol and Comparators against Achromobacter spp

Presenter: Ryuichiro Nakai, MSc

Poster #1106: Evaluation of Penetration of Cefiderocol into Cerebrospinal Fluid Using a Rat Meningitis Model

Presenter: Miki Takemura, M.S.

Poster #1232: In Vitro Activity of Cefiderocol and Comparator Agents against Molecularly-characterized Carbapenem-resistant Enterobacterales Clinical Isolates Causing Infection in United States Hospitals (2020)

Presenter: Rodrigo E. Mendes, Ph.D.

Poster #1256: Clinical Response by Minimum Inhibitory Concentrations in Carbapenem-Resistant Pseudomonas aeruginosa Infections under Cefiderocol Compassionate Use Program

Presenter: Michael Satlin, M.D.

Poster #1272: Cefiderocol In Vitro Activity against Molecularly characterized Acinetobacter baumannii-calcoaceticus complex and Pseudomonas aeruginosa Clinical Isolates Causing Infection in United States Hospitals (2020)

Presenter: Rodrigo E. Mendes, Ph.D.

Poster #1287: Double Disk Diffusion Study to Evaluate the Synergistic Effect Between Cefiderocol and Ceftazidime-Avibactam Against Cefiderocol-non-susceptible Acinetobacter baumannii

Presenter: Yoshinori Yamano, Ph.D.

Poster #1291: PROVE (Retrospective Cefiderocol Chart Review) Study of Real-World Outcomes and Safety in the Treatment of Patients with Gram-negative Bacterial Infections in the US and Europe

Presenter: Stephen W. Marcella, M.D., M.P.H.

Poster #1308: Activity of Cefiderocol and Comparators against Gram-negative Isolates from US Patients Hospitalized with Pneumonia

Presenter: Dee Shortridge, Ph.D.

For additional information related to FETROJA, please contact Shionogi at [email protected].

About FETROJA^® (cefiderocol) for Injection

FETROJA^®(cefiderocol) is a cephalosporin antibiotic with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, FETROJA binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria. These mechanisms allow FETROJA to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells. FETROJA has also demonstrated in vitro activity against certain bacteria that contain very problematic resistant enzymes such as ESBLs, AmpC, serine- and metallo-carbapenemases. Data from multinational surveillance studies for FETROJA demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant A. baumannii, P. aeruginosa, Enterobacterales, and S. maltophilia. The clinical significance of the in vitro data is unknown. FETROJA has poor in vitro activity against Gram-positive or anaerobic bacteria.

Cefiderocol, under the brand name FETCROJA^®, is approved by the European Commission for the treatment of infections due to aerobic Gram-negative bacteria in adults 18 years or older with limited treatment options.

US INDICATIONS

Fetroja^®(cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.

Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.

USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

SELECT IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja.

WARNINGS AND PRECAUTIONS

Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections

An increase in all-cause mortality was observed in patients treated with Fetroja as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595). Patients with nosocomial pneumonia, bloodstream infections, sepsis, or cUTI were included in the trial. BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most of the BAT regimens contained colistin.

The increase in all-cause mortality occurred in patients treated for nosocomial pneumonia, bloodstream infections, or sepsis. The 28-Day all-cause mortality was higher in patients treated with Fetroja than in patients treated with BAT [25/101 (24.8%) vs 9/49 (18.4%), treatment difference 6.4%, 95% CI (-8.6, 19.2)]. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49 [34/101 (33.7%) vs 10/49 (20.4%), treatment difference 13.3%, 95% CI (-2.5, 26.9)]. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established.

Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP.

For Full US Prescribing Information, please visit Shionogi.com

Shionogi’s commitment to fighting antimicrobial resistance

Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continue to focus on research and development in anti-infectives. The company invests the highest proportion of its pharmaceutical revenues in relevant anti-infectives R&D compared to other large pharmaceutical companies.¹

For more information, please refer to: https://www.shionogi.com/global/en/sustainability/amr.html

About Shionogi

Shionogi & Co., Ltd. is a Japanese major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, cardiovascular diseases, and gastroenterology. Our pipeline is focused on infectious disease, pain, CNS, and oncology. For more information on Shionogi & Co., Ltd., visit https://www.shionogi.com/global/en/. Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd. based in N.J. For more information on Shionogi Inc., please visit www.shionogi.com.

Forward Looking Statement

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

¹ Antimicrobial Resistance Benchmark 2020.

https://accesstomedicinefoundation.org/media/uploads/downloads/5f3f76733efaa_Antimicrobial_Resistance_Benchmark_2020.pdf Last accessed September 2021.