Business Wire

Shionogi’s Innovative Antibiotic, FETCROJA ® (cefiderocol), Is Now Available in Norway

Share

Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), today announces that its innovative antibiotic, cefiderocol, is now available in Norway 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 Norway through two distributors: Alliance Healthcare and Norsk Medisinaldepot (further details below).

Since its European Commission approval in 2020, over 23,000 patients in total have now been treated with cefiderocol throughout Europe. Data from multinational surveillance studies for cefiderocol have demonstrated potent in vitro activity against a broad spectrum of aerobic Gram-negative pathogens including all three WHO critical priority pathogens: carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacterales,2,3 as well as Stenotrophomonas maltophilia.6 Cefiderocol has also demonstrated in vitro activity against certain bacteria that contain very problematic resistant enzymes such as ESBLs, AmpC, serine- and metallo-carbapenemases.7,8

Data from three clinical studies: APEKS-cUTI, APEKS-NP, and CREDIBLE-CR support the indication of cefiderocol in adult patients with limited treatment options for the treatment of infections due to aerobic Gram-negative organisms.1 One of the studies included patients with Gram-negative infections caused by multidrug-resistant pathogens including carbapenem-resistant bacteria from the WHO priority list.2

“Over the past years, we have seen an increase in antimicrobial resistance in Norway and worldwide. The approval of new and effective antibiotic treatment options such as cefiderocol is very welcome news for both healthcare professionals and patients as it gives us a potential tool to treat some of the most challenging, multidrug resistant infections” commented Dirk Linke, President of the Norwegian Microbiology Society. “It is critical that we prioritise research and development in this area, ensuring sustainable pipelines for antibiotics development, better diagnostics, and responsible use to tackle this growing threat.”

AMR is a major health burden which urgently needs to be addressed. Between 2016 and 2020, a significant increasing trend in the estimated number of antibiotic-resistant infections was observed in Norway, with 2,000 cases in 2020 alone.5 Infections caused by carbapenem-resistant Gram-negative bacteria are often associated with a high mortality rate,9 resulting in ~35,000 deaths per year in the EU.10 If no action is taken, antibiotic resistance is predicted to kill 10 million people every year globally by 2050, at a cumulative cost to global economic output of 100 trillion USD.11

In 2015, a National Strategy against Antibiotic Resistance was agreed upon in Norway, setting ambitious targets to achieve by 2020.12 However, due to the COVID-19 pandemic, this strategy period has been extended.13 The overarching goals include more appropriate use of antibiotics in humans and animals, substantial reduction in consumption, improved understanding of AMR and to act as a driving force in international, normative work to strengthen access, responsible use and development of new antibiotics, vaccines and better diagnostic tools.14 To tackle the antibiotic market failure in Norway, a partially delinked pull incentive model was designed in 2018, aimed to ensure correct use, conservation and stable supply of critically important antibiotics.14 While this model has great potential, it is yet to be implemented.

Cefiderocol is available to purchase in Norway through the following distributors using the contact details below:

Alliance Healthcare
E-mail: kundeservice@alliance-healthcare.no
Phone: +47 64 85 04 00

Norsk Medisinaldepot (NMD)
Email: kundeservice@nmd.no
Phone: +47 24 05 30 00

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.15,16 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.17

Cefiderocol
Cefiderocol is the first siderophore cephalosporin antibiotic with a unique mechanism of entry through the outer membrane of Gram-negative pathogens by using the bacteria’s own iron uptake system to gain cell entry, acting like a Trojan horse.4 In addition to entering cells by passive diffusion through porin channels,18 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.19 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.4

Carbapenem resistance (CR) in Gram-negative bacteria is due to three main mechanisms:

  • Beta-lactamases which cause enzymatic breakdown of beta-lactams
  • Changes in porin channels (through mutations and decrease in number) through which beta-lactams and other antibiotics diffuse into cells,
  • Overexpression of efflux pumps which occurs post-exposure and pumps antibiotics out of cells20

As a result of its unique structure and mechanism of cell uptake, cefiderocol can overcome these three major mechanisms of CR.

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.21

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.

FETCROJA SMPC: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf

Job bag number: NP-NO-FDC-0001
Preparation date: January 2023

References

1 FETCROJA SMPC. Available at: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdfLast accessed January 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 January 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 January 2023
4 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
5 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 January 2023
6 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. Antimicrob Agents Chemother. 2017 Sep; 61(9): e00093-17.
7 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). Int J Antimicrob Agents. 2019 Feb;53(2):177-184
8 A Ito et al.In Vitro Antibacterial Properties of Cefiderocol, a Novel Siderophore Cephalosporin, against Gram-Negative Bacteria. Antimicrobial Agents and Chemotherapy, 2018, 62(1):e01454-17.
9 Perez F, et al. ‘Carbapenem-Resistant Enterobacteriaceae: A Menace to our Most Vulnerable Patients’. Cleve Clin J Med. Apr 2013; 80(4): 225–33
10 European Centre for Disease Prevention and Control (ECDC). 35,000 annual deaths from antimicrobial resistance in the EU/EEA. Available at: https://www.ecdc.europa.eu/en/news-events/eaad-2022-launch#:~:text=More%20than%2035%20000%20people,a%20new%20report%20released%20today. Accessed January 2023
11 O’Neill J. ‘Tackling Drug-Resistant Infections Globally: Final Report and Recommendations’. The Review on Antimicrobial Resistance. May 2016. https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf Last accessed December 2022
12 Norwegian Ministries. National Strategy against Antibiotic Resistance 2015 – 2020. 2015. Retrieved from https://www.regjeringen.no/contentassets/5eaf66ac392143b3b2054aed90b85210/antibiotic-resistance-engelsk-lavopploslig-versjon-for-nett-10-09-15.pdf. Accessed January 2023
13 NORM, NORM-VET. Usage of Antimicrobial Agents and Occurrence of Antimicrobial Resistance in Norway. 2021. Retrieved from https://www.fhi.no/contentassets/c183b18ccc4a4005a6b9cfae28c97351/norm-norm-vet-2021.pdf. Accessed January 2023
14 Ardal, C. et al. Designing a Delinked Incentive for Critical Antibiotics: Lessons from Norway. The Journal of Law, Medicine & Ethics, 2018; 46(1): 43–49.
15 Tangden 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.
16 Brooke JS. Stenotrophomonas maltophilia: an Emerging Global Opportunistic Pathogen.Clin Microbiol Rev. 2012;25(1):2-41.
17 Antimicrobial Drugs Advisory Committee Cefiderocol Briefing Document. https://www.fda.gov/media/131705/download Last accessed December 2022
18 Fetcroja EMA Assessment Report. https://www.ema.europa.eu/en/documents/assessment-report/fetcroja-epar-public-assessment-report_en.pdf. Last accessed January 2023
19 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
20 Carbapenem Resistance: Mechanisms and Drivers of Global Menace. https://www.intechopen.com/online-first/carbapenem-resistance-mechanisms-and-drivers-of-global-menace Last accessed January 2023
21 Antimicrobial Resistance Benchmark 2021.
https://accesstomedicinefoundation.org/media/uploads/downloads/61ee760d03810_Antimicrobial%20Resistance%20Benchmark%20report%202021.pdf Last accessed January 2023

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

For further information, contact:
Shionogi EU contact
Russell Stapley
russell.stapley@shionogi.eu

Havas SO Media contact
Nicola Lilley
Client Services Director
+44 07983 128 712
nicola.lilley@havasso.com

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

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 21:14:00 CET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

LambdaTest Launches The Phoenix Project, an Employee Resource Group for Women28.3.2024 16:00:00 CET | Press release

LambdaTest, a leading cloud-based unified testing platform, announced the launch of The Phoenix Project, an Employee Resource Group (ERG) dedicated to supporting and promoting the success of its female employees. “LambdaTest is committed to fostering a diverse, inclusive, and equitable workplace where all employees feel valued and empowered to reach their full potential,” said Chandini Chopra, VP of People and Culture at LambdaTest. “The Phoenix Project is a critical step towards achieving this goal by providing a platform for professional development, networking, and mentorship, especially for our women employees.” The Phoenix Project Aims To: Offer professional development workshops, networking opportunities, and dedicated time off for women to participate in ERG initiatives. Provide mentorship programs connecting senior female employees with mentees. Promote leadership development among women within the company. Create a sense of community for women in the workplace. Leadership and

The reopening of the Yokohama Museum of Art adds another innovative and distinctive venue for events in Yokohama28.3.2024 16:00:00 CET | Press release

After extensive renovations, the iconic Yokohama Museum of Art has reopened its doors to visitors from all over the world. The museum’s reopening paves the way to new and closer collaboration with international events in Yokohama. This extraordinary venue is the ideal setting for a one-of-a-kind gathering, in part, supported by the Yokohama Convention & Visitors Bureau (hereinafter YCVB). The Yokohama Museum of Art Founded in 1989, the Yokohama Museum of Art collects over 14,000 works of art that reflect the many facets of life in Yokohama—past, present, and future. The reopening of the museum coincides with the Yokohama Triennale, an international exhibition featuring contemporary artists whose decentralized exhibits turn the entire metropolis into an art museum. The 8th Yokohama Triennale is being held from March 15 to June 9, 2024, with the Yokohama Museum of Art being a pivotal venue for the exhibition. With the museum firmly back on the map as Yokohama’s leading artistic venue, YC

Eight new sustainability-themed experiences—exclusive to Yokohama—for convention participants28.3.2024 16:00:00 CET | Press release

In a survey conducted by Yokohama Convention & Visitors Bureau (hereinafter YCVB), many convention attendees expressed particular interest in Yokohama’s culture, sightseeing spots, and local cuisine. In response, YCVB has developed eight new Yokohama Tours for event attendees to enjoy during their free time in Yokohama, keeping in line with our ethos of sustainability. Noge Area Bar-Hopping Tour, complete with guide Known affectionately by locals as Yokohama’s kitchen, Noge is a bustling nightlife spot that is home to over 600 izakaya (Japanese-style pubs). A knowledgeable local guide will lead participants to all the hidden gems in Noge, where they can indulge in distinctive, delicious pub-style food and drink. With easy on-foot accessibility, participants can rest assured this fun night out won’t impact their carbon footprint. Soto Zen Tour of Sojiji, head temple of the Soto Zen school As a prominent Zen sect in Japan, Soto Zen provides one of the best Zen wellness experiences. Durin

Nordson EFD Releases New 3-Axis Automated Fluid Dispensing Systems28.3.2024 15:00:00 CET | Press release

Nordson EFD, a Nordson company (NASDAQ: NDSN) and leading precision fluid dispensing systems manufacturer is proud to announce the new GVPlus and PROX families of automated fluid dispensing products. Both robotic solutions share a focus on motion, workspace, repeatability, payload, setup, and vision technology enhancements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240305726899/en/ The GV Series offers market-leading dimensional positional accuracy and deposit placement repeatability. (Photo: Business Wire) The new GVPlus automated fluid dispensing solution offers improved repeatability, bigger payloads with simplified setup requirements, and superior vision capabilities. Repeatability is now best-in-class at 8 μm, improving repeatability to ±0.008 mm. Setting up the robot is easier due to a new dual mounting flange that enables a tool payload of up to 4.5 kg (10 lbs). When paired with the working area of 400 mm x 400 m

HiddenA line styled icon from Orion Icon Library.Eye