Shionogi�s Antibiotic, FETCROJA� (cefiderocol), Is Now Available in the Netherlands

FOR DUTCH MEDICAL AND PHARMA TRADE MEDIA ONLY

• FETCROJA^� (cefiderocol) is now available in the Netherlands for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options¹
• Cefiderocol provides coverage against all Gram-negative pathogens considered of critical priority by the WHO – carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacterales^2,3
• Antimicrobial resistance (AMR) is a major health burden which urgently needs to be addressed, with 6,000 cases of antibiotic-resistant infections found in the Netherlands in 2020 alone⁴

OSAKA, Japan & AMSTERDAM–(BUSINESS WIRE)–Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter “Shionogi”), today announces that its antibiotic, cefiderocol, is now available in the Netherlands for the treatment of infections due to aerobic Gram-negative bacteria in adults (18 years or older) with limited treatment options.¹

Cefiderocol is available to purchase in the Netherlands through Alloga (Nederland) B.V.

The Netherlands, home to Shionogi’s European Headquarters, keeps AMR high on their political agenda. AMR is managed from a One Health approach, ensuring measures are in place in all areas where the spread of resistant bacteria occurs; healthcare, livestock farming, the environment and food.⁵ Along with enforcing strict rules to minimise the use of antibiotics and spread of resistant bacteria, the Dutch government are dedicated to investigating antibiotic resistance in food and the environment to better their approach in preventing the spread.⁵ In 2017, the Netherlands Antibiotics Development Platform (NADP) was set up, which encourages companies to develop new antibiotics and new ways to treat people. In addition, the government has provided a subsidy to support the development of bacterial vaccines, so fewer antibiotics are needed.⁶

“This launch in The Netherlands is an important step in rapidly expanding access to cefiderocol across Europe, where we are seeing an increasing trend in the number of antibiotic-resistant infections. Our goal is to ensure availability to clinicians of our new treatment option for all adult patients experiencing aerobic Gram-negative organisms who have limited treatment options,” said Huw Tippett, CEO, Shionogi Europe.

“This is particularly important to us because we recently opened our new European headquarters in Amsterdam, a great city with a thriving life science community as well as world renowned knowledge institutions, public-private partnerships, a strategic location and of course the presence of key regulatory bodies such as the European Medicines Agency. We look forward to working with all stakeholders to ultimately improve the health of Dutch patients wherever possible.”

Resistant Gram-negative infections

The increasing resistance of many infections caused by Gram-negative bacteria to existing therapies, including carbapenem-resistant Enterobacterales and non-fermenting species such as P. aeruginosa, A. baumannii, and S. maltophilia, makes them difficult to treat and results in high mortality rates.^7,8 The World Health Organization have identified carbapenem-resistant strains of Enterobacterales, P. aeruginosa and A. baumannii as the top priority in the research and development of new antibiotics.² Cefiderocol is the first antibiotic to address all three major mechanisms of carbapenem-resistance and is an important treatment option to address this urgent unmet need.⁹

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.¹⁰

About Shionogi

Shionogi & Co., Ltd. is a 142-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 http://www.shionogi.co.jp/en/.

Shionogi B.V. is the European headquarters of Shionogi & Co., Ltd. For more information on Shionogi B.V., please visit www.shionogi.eu.

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.

© 2023 Shionogi Europe. London, WC2B 6UF. All Rights Reserved.

References

¹ FETCROJA SMPC. Available at: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf Last accessed February 2023

² World Health Organization. WHO publishes list of bacteria for which new antibiotics are urgently needed. February 27, 2017. Retrieved from https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed. Last accessed February 2023

³ World Health Organization. 2019 Antibacterial Agents in Clinical Development. 2019. Retrieved from https://apps.who.int/iris/bitstream/handle/10665/330420/9789240000193-eng.pdf Last accessed February 2023

⁴ European Centre for Disease Prevention and Control (ECDC). Assessing the health burden of infections with antibiotic-resistant bacteria in the EU/EEA, 2016–2020. Annex 2: Individual country results. 2022. Retrieved from https://www.ecdc.europa.eu/sites/default/files/documents/Annex_2_burden_estimates_country_sheets.pdf. Accessed February 2023

⁵ Central Government. Antibiotic resistance measures. Available at https://www.rijksoverheid.nl/onderwerpen/antibioticaresistentie/aanpak-antibioticaresistentie. Accessed February 2023

⁶ Central Government. Research into new antibiotics and alternatives. Available at: https://www.rijksoverheid.nl/onderwerpen/antibioticaresistentie/onderzoek-nieuwe-antibiotica-en-alternatieven. Accessed February 2023

⁷Tangden T, Giske CG. Global dissemination of extensively drug-resistant carbapenemase-producing Enterobacteriaceae: clinical perspectives on detection, treatment and infection control. J Intern Med 2015; 277:501?12.

⁸ Brooke JS. Stenotrophomonas maltophilia: an Emerging Global Opportunistic Pathogen.Clin Microbiol Rev. 2012;25(1):2-41.

⁹ Antimicrobial Drugs Advisory Committee Cefiderocol Briefing Document. https://www.fda.gov/media/131705/download Last accessed February 2023

¹⁰ Antimicrobial Resistance Benchmark 2021.

https://accesstomedicinefoundation.org/medialibrary/resources/61ee760d03810_Antimicrobial%20Resistance%20Benchmark%20report%202021.pdf Last accessed February 2023

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Preparation date: February 2023

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