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Last week, Shionogi partnered with the Active Citizenship Network and Members of the European Parliament (MEPs) to host an EU Parliament event calling for collaboration to drive policy change and implementation in the fight against antimicrobial resistance (AMR) within the EU and its Member States.
Urgent action is needed to encourage and support the discovery and development of new antibiotics as well as access models that reward innovation and appropriate use to address the growing threat of antimicrobial resistance.
Although antimicrobial resistance is a slower-moving threat, it is no less serious than COVID-19: In 2019, there were an estimated 1.27 million deaths attributed to antibiotic-resistant bacteria.1 And future projections of the impact of unresolved antimicrobial resistance reach 10 million deaths per year by 2050.2
Osaka, Japan and Amsterdam, November 21, 2022– (working wire) – Shionogi & Co., Ltd. and its European subsidiary Shionogi BV (hereinafter referred to as “Shionogi”) held an event in the European Parliament last week in the run-up to World Antimicrobial Awareness Week, in collaboration with MEPs, activated the Citizenship Network and the MEPs Interest Group on “European Patient Rights and Care Health Across Borders” to discuss initiatives to tackle antimicrobial resistance. This event reinforced the need for urgent attention and collaboration from pharmaceutical companies, political stakeholders and governments to drive policy change and innovation to address this growing issue.
The European Health Federation has declared that antimicrobial resistance is one of the top three priority health threats in the European Union that requires urgent attention and action. In the context of the review of pharmaceutical legislation and the recommendations of the European Council on antimicrobial resistance to take place in the fourth quarter of 2022, the event brought together high-level European policy makers to discuss the innovation framework for the development of new antibiotics based on concrete examples of initiatives undertaken by national health authorities to combat AMR. The event also explored collaboration and governance models to achieve better implementation of procedures and best practices for a comprehensive approach against antimicrobial resistance.
“The meeting was crucial for raising awareness of antimicrobial resistance and the need for new innovations to address unmet needs. I call on patient organisations, industry, the European Commission, academia and healthcare professionals to work together to drive policy change and put in place a joint response to this growing societal challenge,” said MEP Aldo Patriciello.
“The inclusion of AMR in the work program of the upcoming Swedish Presidency of the Council of the European Union and the prioritization of the topic by the European Health Emergency Preparedness and Response Authority (HERA) offers the opportunity to drive policy actions to improve oversight, monitor patterns of resistance across Europe and stimulate innovation. These actions must be integrated The participation of civil society and patient advocacy groups is also critical to the development and implementation of national antimicrobial resistance plans.” Mariano Fotta, Director of the Active Citizenship Network, European Union branch of the Italian NGO Cittadinanzattiva commented.
MEP Fabio Massimo Castaldo also stressed the importance of developing a predictable regulatory environment to stimulate private investment in new antibiotics, as well as establishing rapid procurement and acquisition mechanisms for crisis-related medical countermeasures to respond to emerging threats and better prepare European health systems. mention it “With the adoption of the Global Health Strategy and review of pharmaceutical legislation, the time for action is now, and as Members of the European Parliament, we will thoroughly review these proposals to ensure they meet the desired objective and ambition.”
In 2019, antibiotic-causing bacteria were directly responsible for 1.27 million deaths and were associated with nearly 5 million deaths.2 Future projections of the impact of unresolved antimicrobial resistance reach 10 million deaths per year by 2050.3 Antibiotics are essential for every aspect of modern healthcare, from common surgeries to chemotherapy and organ transplants. Unless urgent action is taken, we may face a future in which a shortage of effective antibiotics can make routine medical procedures dangerous, make more complex interventions and procedures impossible, and reduce our ability to respond to outbreaks of infectious diseases. It was named by Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), a A slow tsunami threatens to undo a century of medical progress..
“We know that stimulating innovation is critical in order to stimulate antimicrobial research and development and a pipeline of new and effective antibiotics, and this is essential both at a European and domestic level. We have seen specific examples of successful models implemented in European countries and urge other EU member states to follow suit and consider similar incentives to help address the challenges faced in bringing new antibiotics to market.Mark Hill, Senior Vice President, Global Head of Value and Access, Shionogi.
While developing antibiotics is a lengthy, expensive, and uncertain process, commercializing them can also be challenging. Once released, understandably, there is often a low frequency of use driven by the need for supervision to prevent the development of resistance. Low usage leads to limited revenue, which in turn restricts continued marketing and new product research. As a result of these economic challenges, many large pharmaceutical companies are no longer active in developing and marketing antibiotics, and many smaller biotech companies have filed for bankruptcy. Shionogi strongly supports the introduction of new incentives, financing models, and value-for-payment valuations to restore a viable commercial market to meet the economic challenge of bringing new antibiotics to market, while strengthening oversight.
Shionogi is committed to maintaining momentum and leveraging collaborations with civil society, policymakers, industry, academia, and healthcare professionals to champion innovation to collectively change direction in the fight against antimicrobial resistance.
Antimicrobial resistance (AMR)
Antimicrobial resistance (AMR) is a significant health burden that needs to be addressed urgently. Infections caused by carbapenem-resistant Gram-negative bacteria are often associated with a high mortality rate.3 If no action is taken, antibiotic resistance is expected to kill 10 million people each year by 2050, at a cumulative cost to global economic output of US$100 trillion.3
Shionogi’s commitment to combating antimicrobial resistance
Shionogi has a strong heritage in anti-infectives and has been developing antimicrobial treatments 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 the field of anti-infectives. The company invests a higher percentage of its pharmaceutical revenues in anti-infective research and development than any other large pharmaceutical company.4
For more information please refer to: https://www.shionogi.com/global/en/sustainability/amr.html
Shionogi & Co. Ltd., is a 142-year-old, research-driven global pharmaceutical company headquartered in Osaka, Japan, dedicated to bringing benefits to patients based on the corporate philosophy of “providing the best possible medicine to protect the health and well-being of the patients we serve”. The company currently markets products in several therapeutic areas including anti-infectives, pain relievers, central nervous system disorders, cardiovascular diseases, and gastroenterology. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases, and pain/central nervous system disorders.
For more information about Shionogi & Co., Ltd. , please visit https://www.shionogi.com/global/en/
Shionogi BV is the European headquarters of Shionogi & Co., Ltd. For more information about Shionogi BV, please visit www.shionogi.eu.
This announcement contains forward-looking statements. These statements are based on expectations in light of currently available information, and assumptions that are subject to risks and uncertainties that 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, changes in interest rates and the currency exchange rate. These risks and uncertainties apply specifically with respect to forward-looking statements regarding a product. 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 effectiveness; technological developments; the adverse outcome of important litigation; Domestic and foreign health care reforms and changing laws and regulations. For existing products also, 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.
© 2022 Shionogi Europe. All rights reserved.
1 Collaborators in antimicrobial resistance. The global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399: 629-655. doi: doi.org/10.1016/ S0140-6736(21) 02724-0. Available online: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext. Last accessed November 2022.
2 O’Neill, J. et al. Antimicrobial resistance review. Treating drug-resistant infections globally: final report and recommendations. 2016 https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf Last accessed November 2022
3 Perez F, and others. ‘Carbapenem-resistant Enterobacteriaceae: A Threat to Our Most Vulnerable Patients’. Cliff Clin J Med. April 2013; 80 (4): 225-33
4 Antimicrobial Resistance Standard 2021.https://accesstomedicinefoundation.org/media/uploads/downloads/61ee760d03810_Antimicrobial%20Resistance%20Benchmark%20report%202021.pdf Last accessed November 2022
Job Code: NP-EU-FDC-0398
Preparation date: November 2022
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