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

Shionogi & Co., Ltd. (hereafter “Shionogi”) today announces that 11 abstracts on FETCROJA^® (cefiderocol) will be shared at IDWeek. The meeting will take place virtually from September 29 - October 3, 2021.

“The data presented at IDWeek contributes to the growing body of evidence that shows FETCROJA has the potential to treat 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 with the infectious disease community while underscoring our commitment to fighting antimicrobial resistance.”

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

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

Presenter: Dee Shortridge, PhD

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

Presenter: Rodrigo E. Mendes, PhD

• 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, PhD

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

Presenter: Sean Nguyen, PharmD

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

Presenter: Miki Takemura, MS

• 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, PhD

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

Presenter: Ryuichiro Nakai, MSc

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

Presenter: Merime Ota, BSc

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

Presenter: Michael Satlin, MD

• 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, MD, MPH

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

Presenter: Vidmantas Petraitis, MD

For additional information related to cefiderocol, please contact Shionogi at medinfo@shionogi.com.

About FETCROJA^® (cefiderocol)

Cefiderocol is a siderophore 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, cefiderocol 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.¹ These mechanisms allow cefiderocol to achieve higher concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells.² Cefiderocol has also demonstrated in vitro activity against certain bacteria that contain very problematic resistant enzymes such as ESBLs, AmpC, serine- and metallo-carbapenemases.^3,4 Data from multinational surveillance studies for cefiderocol demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant A. baumannii, P. aeruginosa, Enterobacterales, and S. maltophilia.⁵ The clinical significance of the in vitro data is unknown. Cefiderocol has no clinically relevant activity against Gram-positive or anaerobic bacteria.

Cefiderocol is commercially available in the U.S after approval by the FDA in 2019 under the brand name FETROJA^® for patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteusmirabilis, P.aeruginosa, and Enterobacter cloacae complex.

FETROJA is also 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: A. baumannii complex, E. coli, E. cloacae complex, K. pneumoniae, P. aeruginosa, and Serratia marcescens.

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 continues 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.⁶

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

About Shionogi

Shionogi & Co., Ltd. is a 143-year-old global, research driven pharmaceutical company headquartered in Osaka, Japan, that is 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, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders.

For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en/

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, lack of availability 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.

References

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¹ Ito A, Nishikawa T., Masumoto S, et al. Siderophore Cephalosporin Cefiderocol Utilizes Ferric Iron Transporter Systems for Antibacterial Activity against Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2016;60(12):7396-7401

² Tillotson GS. Trojan Horse Antibiotics—A Novel Way to Circumvent Gram-Negative Bacterial Resistance? Infectious Diseases: Research and Treatment. 2016;9:45-52 doi:10.4137/IDRT.S3156

³ K Kazmierczak et al. In vitro activity of cefiderocol, a siderophore cephalosporin, against a recent collection of clinically relevant carbapenem-non-susceptible Gram-negative bacilli, including serine carbapenemase- and metallo-β-lactamase-producing isolates (SIDERO-WT-2014 Study). International Journal ofAntimicrobial Agents, 2019; 53(2) 177-184

⁴ A Ito et al.In Vitro Antibacterial Properties of Cefiderocol, a Novel Siderophore Cephalosporin, against Gram-Negative Bacteria. Antimicrobial Agents and Chemotherapy, 2018, 62:e01454-17.

⁵ M Hackel, M Tsuji, Y Yamano, et al. In Vitro Activity of the Siderophore Cephalosporin, Cefiderocol, Against a Recent Collection of Clinically Relevant Gram-Negative Bacilli from North America and Europe, Including Carbapenem Non- Susceptible Isolates: The SIDERO-WT-2014 Study. Antimicrobial Agents Chemotherapy. 2017;61(9)

⁶ Antimicrobial Resistance Benchmark 2020. https://accesstomedicinefoundation.org/media/uploads/downloads/5e270aa36821a_Antimicrobial_Resistance_Benchmark_2020 pdf Last accessed September 2021

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Contact information

For further information, contact:
Shionogi & Co., Ltd.
https://www.shionogi.com/global/en/contact.html

Lindsay Bohlander, Senior Director, Corporate Planning & Communications
+1 973-307-3718
Lindsay.Bohlander@shionogi.com