FOR MEDICAL, HEALTHCARE TRADE AND POLICY MEDIA ONLY

• 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 member states.
• Urgent action is needed to encourage and support the discovery and development of novel antibiotics as well as access models that reward innovation and appropriate use to address the growing threat of AMR
• Although AMR is a slower moving threat, it is no less dangerous than COVID-19: in 2019, there were an estimated 1.27 million deaths attributable to bacterial AMR¹ and future projections for the impact of unresolved AMR are as high as 10 million deaths per year by 2050²

OSAKA, Japan & AMSTERDAM--(BUSINESS WIRE)--Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), held an event at the EU Parliament last week in the run-up to World Antimicrobial Awareness Week, joining forces with MEPs, Active Citizenship Network and MEPs Interest Group on "European Patients' Rights & Cross-Border Healthcare" to discuss initiatives to tackle AMR. The event reinforced the need for urgent attention and collaboration from pharmaceutical companies, policy stakeholders and governments to bring about policy change and innovation to address this growing issue.

The European Health Union has declared AMR one of its top three priority health threats in the EU requiring urgent attention and action. Within the context of the revision of the Pharmaceutical Legislation and the planned European Council Recommendations on AMR taking place in Q4 2022, the event brought together high-level European policymakers to discuss the innovation framework for the development of new antibiotics based on concrete examples of initiatives conducted by national health authorities to fight AMR. The event also explored collaborative and governance models to achieve better implementation of actions and best practices for a holistic AMR approach.

�The meeting was crucial to increase awareness of Antimicrobial Resistance and the need for new innovations to address unmet needs. I�m calling on patient organisations, industry, the European Commission, academia, and healthcare professionals to work together to drive policy change and put in place a common response to this increasing societal challenge,� said MEP Aldo Patriciello.

"The inclusion of the AMR within the work programme of the incoming Sweden Presidency of the Council of the EU and the prioritisation of the topic by the European Health Emergency Preparedness and Response Authority (HERA) give the opportunity to advance policy action to improve stewardship, surveillance of resistance patterns across Europe and incentivise innovation. These actions should be fully integrated into One Health Strategies providing solutions for human, animal and environmental health. The involvement of civic society and patient advocacy groups is also crucial in the development and implementation of AMR National Plans" commented Mariano Votta, Director of Active Citizenship Network, the EU branch of the Italian NGO Cittadinanzattiva.

MEP Fabio Massimo Castaldo also affirmed the importance of developing a predictable regulatory environment to incentivise private investments in new antibiotics, in addition to setting up rapid procurement and purchase mechanisms for crisis-relevant medical countermeasures to respond to emerging threats and better prepare European health systems. He stated that �with the adoption of the Global Health Strategy and Pharmaceutical Legislation Review, the time to act is now, and as Members of the European Parliament, we will thoroughly review these proposals to ensure it meets the objective and ambition that are needed.�

In 2019, bacterial AMR was directly responsible for 1.27 million deaths and associated with nearly 5 million deaths.² Future projections for the impact of unresolved AMR are as high as 10 million deaths per year by 2050.³ Antibiotics are crucial for every aspect of modern-day healthcare, from common surgeries to chemotherapy and organ transplants. Unless urgent action is taken, we could face a future in which a lack of effective antibiotics could make routine medical procedures dangerous, make more complex interventions and procedures impossible, and reduce our ability to respond to outbreaks of infectious diseases. Tedros Adhanom Ghebreyesus, Director General at the World Health Organization (WHO) has called it a �slow tsunami that threatens to undo a century of medical progress�.

�We know that incentivising innovation is critical in order to stimulate antimicrobial R&D and a pipeline of new and effective antibiotics, and this is necessary at both a European and local country level. We have seen specific examples of successful models which have been 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 novel antibiotics to market,� commented Mark Hill, Senior Vice President, Global Head of Value and Access, Shionogi.

While developing antibiotics is a long, costly and uncertain process, commercialisation can also be challenging. Once launched, understandably, there is often a low frequency of use driven by the need for stewardship to prevent resistance development. Low use leads to limited revenues, which in turn restricts continued commercialisation and new product research. As a result of these economic challenges, many large pharmaceutical companies are no longer active in the development and commercialisation of antibiotics, and several smaller biotech companies have filed for bankruptcy. Shionogi strongly supports the introduction of new incentives, funding and value assessment models for reimbursement to restore a viable commercial market to address the economic challenge faced in bringing novel antibiotics to market, whilst promoting stewardship.

Shionogi is committed to maintaining the momentum and leveraging collaborations with civil society, policymakers, industry, academia, and healthcare professionals to champion innovation to collectively turn the tide in the fight against AMR.

Antimicrobial resistance (AMR)

Antimicrobial resistance (AMR) is a major health burden which urgently needs to be addressed. 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 predicted to kill 10 million people every year by 2050, at a cumulative cost to global economic output of 100 trillion USD.³

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.⁴

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

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 https://www.shionogi.com/global/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 Statements

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.

� 2022 Shionogi Europe. All Rights Reserved.

References

¹ Antimicrobial Resistance Collaborators. 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. Review on antimicrobial resistance. Tackling 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, et al. �Carbapenem-Resistant Enterobacteriaceae: A Menace to our Most Vulnerable Patients�. Cleve Clin J Med. Apr 2013; 80(4): 225�33

⁴ Antimicrobial Resistance Benchmark 2021.https://accesstomedicinefoundation.org/media/uploads/downloads/61ee760d03810_Antimicrobial%20Resistance%20Benchmark%20report%202021.pdf Last accessed November 2022

Job code: NP-EU-FDC-0398

Date of preparation: November 2022

Contacts

For further information, contact:
Shionogi B.V.
Jo Taylor

Executive Director, Corporate and Government Affairs

[email protected]
Havas SO Media Contact
Nicola Lilley

Associate Director

+44 (0)20 3196 9912

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