Medicines for Europe and its Biosimilar Medicines Group took note of the EuropaBio paper on physician preference regarding biosimilar labels (SmPC)[2] which attempts to create an unnecessary differentiation between biosimilar medicines and their reference products, despite the stringent science-based EU approval process guaranteeing full comparability in efficacy and safety. Biosimilar medicines are assessed and authorised based on a head-to head comparison and the ‘totality of evidence’ available, which includes the experience and knowledge gathered for the originator medicine and well captured in the ‘same label’ approach, which is consistent with the EU legal, scientific and regulatory framework, as well as the current practice for all medicines in case of a line extension or following manufacturing changes.
Regrettably, the second part of the paper fails to acknowledge some fundamental elements such as the existing consensus on the need to improve accessibility and suitability of the information on all medicines for both Healthcare Professionals and Patient Communities, beyond the sole product information. The availability of unbiased information from regulatory agencies is typically not an issue thanks to transparent policies where, for example, anyone can access the European Public Assessment Report for any centrally authorised medicine on the EMA website.
According to Adrian van den Hoven, Director General Medicines for Europe, “our Biosimilar Medicines Group is engaged in many multi-stakeholder platforms to facilitate the accessibility and understanding of the information”.
See the Annex document with the full position
[1] Physicians prefer greater detail in the biosimilar label (SmPC) – Results of a survey across seven European countries, A.Hallersten et. al, http://www.sciencedirect.com/science/article/pii/S0273230016300654
[2] Physicians prefer greater detail in the biosimilar label (SmPC) – Results of a survey across seven European countries, A.Hallersten et. al, http://www.sciencedirect.com/science/article/pii/S0273230016300654
Over 100 participants will explore different ways and opportunities to ensure universal access to healthcare, together with members of the European Parliament (MEPs) and healthcare stakeholders. We have jointly agreed that this issue should be a priority on the European political agenda.
“We have now a great opportunity to accelerate our work to date through the Patient Access Partnership and the Riga Roadmap, by also collaborating on the actions needed now to ensure the sustainable development goal on universal access becomes reality by 2030”. Nicola Bedlington, EPF Secretary General.
“Exchange of information and collaboration among the different stakeholders is indispensable to improve access to healthcare. The treatments must not only be available, they also have to be affordable. The annual meetings among the different actors in healthcare are a first step to foster dialogue in order to guarantee high quality health services for everybody”. Menno Aarnout, AIM Executive Director.
“The access to medicines debate is a social justice issue in Europe today. We need a comprehensive dialogue on all issues with a balanced involvement of all stakeholders”. Yannis Natsis, EPHA Policy Coordinator for Universal Access & Affordable medicines.
Better access to medicines leads to better health. For this reason, the EU needs to stimulate competition in pharmaceutical markets post-patent where generic and biosimilar medicines have demonstrated their ability to massively increase access to medicines without raising the overall treatment costs.
Speaking ahead of the event, Adrian van den Hoven, Medicines for Europe Director General, commented that “cooperation among stakeholders is key to improve access to healthcare in Europe. This annual gathering is a great opportunity to build a partnership with stakeholders to deliver access to high quality healthcare, including medicines to patients, while ensuring the sustainability of our systems”.
Medicines for Europe, EPF, EPHA and AIM are looking forward to further progress and milestones promoting better access for better health and to meeting in 2017 for the 4th Edition.
Biosimilar medicines represent an essential opportunity to optimise patient access to high quality treatments and the efficiency of healthcare systems worldwide, according to the white paper “Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets”, published by the IMS Institute for Healthcare Informatics this week. Some 50 new products in clinical development are expected to increase access to medicines through price competition across Europe and the US through 2020.
The white paper highlights the extraordinary contribution of biosimilar medicines to the growing demand of patients to access effective gold standard biological therapies and to address the sustainability of healthcare budgets. The white paper advocates for rapid biosimilar medicines uptake and for a sustainable biosimilar market environment, underlining that patient access to biologic treatments has grown by as much as 100 percent following the availability of biosimilar medicines. In order to maximise the benefits of biosimilars, the report says that acceptance of biosimilar medicines is the largest contributor to success.
Medicines for Europe Director General, Adrian van den Hoven, welcomed the IMS Institute for Healthcare Informatics publication: “This white paper confirms the efforts made by biosimilar manufacturers to invest strongly in better access for patients and more sustainability to pharmaceutical markets across the world. With more than 10 years of positive patient treatment experience and some 20 products successfully launched in Europe, biosimilar medicines provide a huge opportunity today to deliver significantly improved access to modern therapies for millions of European patients in both chronic and acute care in areas such as cancer, diabetes, rheumatoid arthritis or other immune-related diseases. Biosimilar medicines answer one of Europe’s major healthcare challenges: how to ensure that all European patients get equitable access to treatment”.
The European Generic and Biosimilar Medicines Association is now Medicines for Europe Better access. Better health. Generic medicines are now the cornerstone of European healthcare, the Biosimilar medicines sector is developing rapidly, and the need and opportunity for Value Added medicines will further transform healthcare. Our industries supply the majority of Europe’s prescription medicines which is estimated to grow from the current 56% to 75% in volume over the next 5 years, as the demand for access to high quality medicines for European patients has never been greater. The repositioning of our association as Medicines for Europe aims to drive greater healthcare efficiency through better health outcomes while providing solutions for the sustainability of European healthcare systems facing increased demographic demands on healthcare services.
“Medicines for Europe Better access. Better health reflects our industries’ purpose and strategic objectives,” said Medicines for Europe President Jacek Glinka. “As an organisation we have been through an incredible journey responding to the changes that have taken place in the pharmaceutical industry and European healthcare environment. I invite stakeholders and policy-makers to engage with us to deliver access to high quality medicines for all European patients.”
Adrian van den Hoven, Medicines for Europe Director General, added: “Medicines for Europe is a great opportunity to build on the EGA’s established reputation for partnership with stakeholders and authorities to deliver access to high quality medicines for patients, its commitment to the highest levels of quality, and to bringing even more value to pharmaceuticals while bridging the sustainability of healthcare with a competitive pharmaceutical manufacturing industry.”
Last week in Brussels, the European Biosimilar medicines Group (EBG – a sector group of the EGA) elected its new leadership team with Sandoz’ Carol Lynch as Chair of the overall sector group and Polpharma’s Klaus Martin, Chair of the market access group of the EBG.
Carol Lynch is Global Head of Biopharmaceuticals and Oncology Injectables at Sandoz. Lynch has more than 25 years of global pharmaceutical and generics industry experience. Prior to joining Sandoz in 2014, Lynch held several Commercial and Development leadership positions at Novartis Pharmaceuticals both globally and in country organizations, including the United States. She is a member of the Sandoz Executive Committee.
In her new role as Chair of the EBG Group, Carol Lynch highlighted: “The EBG is the leading group in Europe for the biosimilars industry and as the newly elected Chair, I look forward to representing the EBG during what will be another important two years. With fellow EBG members, we will support the expansion of patient access to high-quality biosimilar medicines, while ensuring the sustainability of our industry in Europe and beyond”. Ildiko Aradi, Gedeon Richter, and Karl Heinz Emmert, Teva, were re-elected as Vice-chairs of the EBG.
Klaus Martin is Senior Director at Polpharma Biologics and Chief Science officer, leading global late-stage development, portfolio management and strategic marketing and medical affairs. Klaus has been working on biosimilar medicines since 2002. He has held global management positions at Sandoz Biopharmaceuticals and has been an active member of the EBG since Polpharma joined the EGA in 2014.
As the new Market Access Group Chair, Klaus Martin commented that “Biosimilar medicines are increasingly embraced by markets as an important means to provide better access for patients to better healthcare. However, there are still many barriers to patient access to biosimilar medicines which the EBG will work hard to remove over the next two years”. Dan Ionescu, Sandoz, was appointed Vice-chair of the Market Access Group.
EGA Director General, Adrian van den Hoven, welcomed the new leadership team which will continue leading the way on transforming healthcare, improving access to more safe high quality treatment options for physicians and their patients.
About the EBG and the EGA
The European Biosimilars Group (EBG), a sector group of the EGA, represents the leading companies in the biosimilar medicines space. The EBG Members bring competition to the biologicals market, thereby increasing access to highly innovative medical treatments to patients, in Europe and around the world, and supporting the sustainability of the European healthcare systems.
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 BN more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic, biosimilar and value-added medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please visit: www.egagenerics.com and follow EGA and EBG on Twitter at:@egagenerics and @ebgbiosimilars.
Brussels – The European Generic and Biosimilar Medicines Association (EGA) welcomes the publication in the official journal today of the Delegated Regulation supplementing Directive 2001/83/EC, which implements the Falsified Medicines Directive (2011/62/EU), on the safety features appearing on the packaging of medicines.
This Delegated Regulation will determine the technical specificities of the Unique Identifier and the repositories system that will enable the verification of the authenticity of individual packages of (mainly) prescription medicines.
Together with stakeholders (EFPIA, EAEPC, GIRP, PGEU), EGA will work to ensure the national implementation of an interoperable, pan-European repositories system, called the European Medicines Verification blueprint System.
Adrian van den Hoven, Director General of the European Generic and Biosimilar medicines Association (EGA) said “We are confident that the implementation of the European Medicines Verification Blueprint System will be a major step forward for the fight against counterfeit medicines. To ensure that our industries continue to deliver access to high quality medicines and to improve patient safety, we plan to work closely with Member States to allow the industries to apply voluntarily the safety features when needed to increase patient safety even more”.
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 billion more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic and biosimilar medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on twitter @egagenerics and @ebgbiosimilars.
London – 61 regulators from 25 countries made progress in improving the generic and biosimilar medicines regulatory landscape for patient needs at the 15th Regulatory and Scientific Affairs Conference organised by the European Generic and Biosimilar medicines Association (EGA).
The EMA/HMA Strategy 2020, complemented by the CMDh 2020 Strategy Paper, will pursue operational excellence in the EU Regulatory Network and engagement in international regulatory platforms which will ultimately deliver greater value to public health.
The generic and biosimilar medicines industries presented a number of regulatory improvements in the EGA Regulatory Efficiency report in support of the 2020 strategies.
Promoting high-standard global regulatory convergence, supporting a single development programme for generic and biosimilar medicines and optimising the scope of regulatory processes supported by telematics tools will contribute to better access for better health by 2020.
Adrian van den Hoven, Director General of the European Generic and Biosimilar medicines Association (EGA) said “this event provides an invaluable platform for manufacturers, regulators and stakeholders to improve regulatory efficiency so that our industries can deliver better access to high quality medicines in the future”.
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 billion more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic and biosimilar medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on twitter @egagenerics and@ebgbiosimilars.
London – In London this week, the European Generic and Biosimilar medicines Association (EGA) will gather some of the key national authorities, regulators and industry leaders to discuss how to improve safety for patients in the regulatory frame.
More than three years after the new pharmacovigilance legislation became operational, a continuous and open dialogue between regulators and industry proved to be the key for making significant progress towards better pharmacovigilance for better public protection. Further reduced duplication of effort, targeted administrative simplification and more clearly defined roles and responsibilities for all stakeholders involved are some of the main proposals from regulators and industry to improve safety for patients and therefore bring better access to high quality medicines in Europe.
Speaking ahead of the 9th EGA Pharmacovigilance Conference, Katarina Nedog, Safety and Regulatory Manager, European Generic and Biosimilar medicines Association and coordinator of the conference, commented that “this event provides an invaluable platform for manufacturers, regulators and stakeholders to promote patients’ safety and commit to continuing our work towards a more efficient pharmacovigilance system”.
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 billion more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic and biosimilar medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on twitter @egagenerics and@ebgbiosimilars.
More than 80 leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as key industry bodies, have come together to call on governments and industry to work in parallel in taking comprehensive action against drug-resistant infections – so- called ‘superbugs’ – with a joint declaration launched today at the World Economic Forum in Davos, Switzerland.
The statement sets out for the first time how governments and industry need to work together to support sustained investment in the new products needed to beat the challenges of rising drug resistance.
The Declaration on Combating Antimicrobial Resistance – drafted and signed by 85 companies and nine industry associations across 18 countries1 – represents a major milestone in the global response to these challenges, with commercial drug and diagnostic developers for the first time agreeing on a common set of principles for global action to support antibiotic conservation and the development of new drugs, diagnostics, and vaccines. The industry is calling on governments around the world to now go beyond existing statements of intent and take concrete action, in collaboration with companies, to support investment in the development of antibiotics, diagnostics, vaccines, and other products vital for the prevention and treatment of drug-resistant infections.
In particular, the Declaration supports a continuation of efforts towards improved conservation of antibiotics, including a call for improved uptake of rapid point-of-care diagnostics to improve how antibiotics are prescribed, and changes to incentive structures within health systems that directly reward doctors, pharmacists and veterinarians for prescribing antibiotics in greater volumes.
In what the Review on Antimicrobial Resistance recognises to be a notable step for the industry, the signatory companies call on governments to work with them to develop new and alternative market structures that provide more dependable and sustainable market models for antibiotics, and to commit the funds needed to implement them. These mechanisms are needed to provide appropriate incentives (coupled with safeguards to support antibiotic conservation) for companies to invest in R&D to overcome the formidable technical and scientific challenges of antibiotic discovery and development. These include mechanisms to ensure that, where appropriate, the pricing of antibiotics more adequately reflects the benefits they bring; and novel payment models that reduce the link between the profitability of an antibiotic and the volume sold. An integral part of these models is a reduced need for promotional activity by companies.
As well as calling for continued progress by governments on these fronts, the Declaration sets out a commitment to further action on drug resistance by its signatories, which the Review warmly welcomes. These span across three broad areas:
By bringing together such a wide range of companies in this unprecedented way, the Declaration provides a valuable roadmap to guide further collaborative efforts between industry, governments and NGOs in the global fightback against AMR. The Review will continue to work to drive progress towards a series of key international milestones in 2016 – including likely discussions on AMR at the UN General Assembly and as part of China’s G20 programme in the autumn – and in support of progress against the WHO Global Action Plan on AMR.
The Declaration will be updated every two years, to take account of the evolving global landscape of AMR and changing challenges and priorities. It remains open to accept new signatory companies and bodies at any time, with a complete list maintained on the Review on AMR’s website, www.amr- review.org/industry-declaration
For further detail and background relating to the Declaration and the work of the Review on Antimicrobial Resistance, please see Notes for Editors on page 8.
QUOTES ABOUT THE DECLARATION
Lord Jim O’Neill, Chairman of the Review on Antimicrobial Resistance, said:
“This Declaration from industry is a major step forward in establishing a properly global response to the challenges of drug resistance. I’m really impressed that such a wide range of companies have been able to agree on a common set of principles and commitments across these important issues: this is a level of consensus that we have not previously seen from the industry on this topic.
“With discussions at this year’s UN General Assembly and as part of China’s G20 presidency looking likely, 2016 is set to be a pivotal year in the global fightback against AMR. This Declaration provides a strong basis for my Review, for governments and for NGOs to progress conversations with industry in the coming months about how we can turn these ideas and principles into concrete action.
“The pharmaceutical industry, as well as society at large, cannot afford to ignore the threat of antibiotic resistance, so I commend those companies who have signed the Declaration for recognising the long-term importance of revitalising R&D in antibiotics, and for their leadership in overcoming the difficult issues of collective action at play here.”
Pascal Soriot, Chief Executive of AstraZeneca plc, said:
“We welcome the leadership provided by Lord O’Neill’s Review on AMR, applaud the ongoing global efforts to ensure a sustained pipeline of new therapies is developed and are proud to support this endeavour.
“The Declaration’s call for collaborative action on new commercial models is timely. Industry is ready to engage with governments to develop alternative market structures to enable the sustainable investment that is necessary if we are to overcome the formidable technical and scientific challenges of antibiotic discovery and development.”
Sir Andrew Witty, Chief Executive of GlaxoSmithKline plc, said:
“Antibiotic resistance is the sort of global healthcare challenge that this industry should be using its expertise to tackle. That’s why I’m so pleased to see such a broad range of companies committing to this declaration. At GSK we have a long heritage and expertise in antibiotics, we’ve been researching and providing these medicines since the Second World War and we remain committed to continuing in this area. I’m proud that in spite of the scientific challenges of antibiotic research, we still have an active pipeline, which includes a potential new and first-in-class treatment entering late stage development.
“We are already taking a more open and collaborative approach to our antibiotic research, working in pre-competitive collaborations alongside other companies and academics, to overcome the scientific and technical barriers to developing these medicines. I’m hopeful that today’s declaration will encourage governments to work with us on new economic models that can help to secure a new supply of antibiotics for the future.”
Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson, said:
“We are pleased to be part of this important initiative to combat antimicrobial resistance. Antimicrobials are the backbone of modern medicine, and have played a key role in increasing life expectancy globally. At Johnson & Johnson, our long-standing commitment to innovation in antimicrobial R&D is evident through our legacy products and our new efforts to support ongoing research. For the world to continue to have new antibiotics, we need investments in basic science and novel incentive models for industry R&D, and to protect our existing treatments, we need new frameworks for appropriate use.”
Kenneth C. Frazier, Chairman and Chief Executive, Merck & Co., Inc., Kenilworth, New Jersey, USA, said:
“Antibiotic resistance is an urgent public health issue requiring a comprehensive, global approach. Assuring availability and proper use of effective antibiotics are shared responsibilities and we fully embrace the principles outlined in this declaration.”
Ian C. Read, Chairman and Chief Executive of Pfizer Inc., said:
“The growing problem of antimicrobial resistance requires new approaches and a heightened commitment to development of new treatments and vaccines. Pfizer applauds this declaration as a balanced and robust approach to stimulating R&D through market based incentives, and emphasising the importance of responsible stewardship.”
Dr Olivier Brandicourt, Chief Executive of Sanofi S.A., said:
“Finding solutions to meet this major challenge requires full participation of private and public sectors, non-governmental organisations, regulatory organisations and payers. It will be challenging as antibiotic stewardship must be improved and discovery of new treatments has been elusive.
Although sustainable business models remain to be found, we are up for the challenge. Together I believe we can overcome these hurdles and Sanofi is fully committed to this global effort.”
Dr Isao Teshirogi, President and Chief Executive, Shionogi & Co., Ltd., said:
“Shionogi has been seriously committing to combat AMR for years. Thus, I am pleased to support the declaration from industry, and our company will further contribute to this global challenge as much as we can.”
Dame Sally Davies, UK Chief Medical Officer, said:
“I welcome this Declaration as a clear sign of industry’s collective commitment to beating the threat of antimicrobial resistance, both by reducing unnecessary use of antibiotics and supporting the development of new ones.
“A secure supply of new antibiotics for the future is clearly of vital importance, and I look forward to seeing an advancement of discussions between companies and governments on how we build new and sustainable market models that properly incentivise the discovery and development of new antibiotics, whilst ensuring affordable access to these crucial drugs for all those who need them in all parts of the world.”
Dr Margaret Chan, Director General of the World Health Organization (WHO), said:
“Antimicrobial resistance is beyond the capacity of any organisation or country to manage or mitigate alone. WHO and its Member States have called for the development of new antimicrobial medicines and affordable access to them, in line with the global action plan on antimicrobial resistance. This Declaration affirms that the challenges of AMR can be addressed only through collaboration and global collective action.”
Professor Murat Akova, President of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), said:
“The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) – an independent, non-profit society with a major focus on AMR – welcomes and applauds this broad initiative from industry to embrace all tough commitments necessary to successfully combat antimicrobial resistance. Fair, transparent agreements between industry, governments and the profession will be welcomed by all.”
Johan S. Bakken, MD, PhD, FIDSA, President of the Infectious Diseases Society of America (IDSA), said:
“The Infectious Diseases Society of America (IDSA) applauds the global industry leaders who issued the Declaration on Combating Antimicrobial Resistance. IDSA members are on the front lines treating increasing numbers of patients who suffer from infections caused by multi-drug resistant pathogens, and we have long called for a coordinated effort by all stakeholders to reduce resistance through ID physician led stewardship and to foster the development of urgently needed new antibiotics, diagnostics, and vaccines. We welcome industry’s commitment to work with us, government leaders, and others to address this growing public health crisis.”
Richard Bergström, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said:
“With this statement, my member companies confirm their commitment to new business and valuation models for antibiotics, including those where you at least partially de-link revenues from sales. This will support the dual goal of incentivising research, while limiting consumption to when it is really needed.”
Dr Virginia Acha, Executive Director for Research and Medical Innovation, Association of the British Pharmaceutical Industry (ABPI), said:
“When David Cameron announced the AMR Review work in July 2014, he called for ‘a stronger, more coherent global response, with nations, business and the world of science working together to up our game in the field of antibiotics’. With this global Declaration of Support for Combating AMR, industry has given that response. It is up to us all to make sure that delivers new solutions to address AMR for patients everywhere.”
Kenneth Hillan, Chief Executive of Achaogen Inc., said:
“Achaogen is focused on the urgent need for new antibacterials to treat multi-drug resistant, Gram- negative infections and is committed to participating in the coordinated global action required to address the public health threat posed by AMR. We applaud the efforts of Lord O’Neill’s Review on AMR and are pleased to support this Declaration and the call for collective global measures to overcome the barriers to the development and commercialisation of life-saving antibiotics.”
Neil Murray, Chief Executive of Redx Pharma Plc, said:
“There is a doomsday clock ticking, with the effectiveness of antibiotics diminishing at an alarming rate. The potential consequences of the failure to tackle this crisis have already been highlighted by the UK Government’s O’Neill Review, which talks of 10 million extra deaths a year and a tragic reversal of over three decades of progress in treating TB, malaria and HIV. So Redx Pharma wholeheartedly supports today’s declaration and welcomes any efforts made in public and animal health to diminish the unnecessary use of antibiotics. We also share the widely-held view that new ways must be found to support innovation and drug discovery in this critical area.”
Florence Séjourné, Chief Executive of Da Volterra and co-founder of the BEAM Alliance, said:
“Antibiotic-resistant bacteria, left unchecked, would imperil long-term human stability and development. We welcome the opportunity to bring this life-and-death topic to the forefront at the World Economic Forum 2016. New antibiotics must be developed, and existing ones must be preserved. To this end, antibiotics should be used wisely, and novel strategies to overcome the emergence of resistance encouraged as well. Together with all the leaders and creative minds gathered in Davos, we should and will succeed in defining a future for combating bacterial resistance and better prevent and cure bacterial infections: let’s make it happen.”
Ankit Mahadevia, M.D., Chief Executive of Spero Therapeutics, said:
“We are proud to be part of this important declaration. Antibiotic resistant infections claim at least 50,000 lives each year across Europe and U.S. alone. We will continue to aggressively pursue new models for antibiotics that will curb this worldwide problem.”
Christopher Micetich, President and Chief Executive of Fedora Pharmaceuticals Inc., said:
“Fedora Pharmaceuticals shares the signatories’ commitment to combatting antimicrobial resistance through innovation, stewardship and improved access. We applaud the collaborative spirit expressed by these companies in coming together to address this incredibly important global health issue.”
Avi Pelossof, Global President of Infectious Diseases, Alere Inc., said:
“Alere is proud to support this declaration and is committed to improving the uptake of rapid point- of-care diagnostics, helping healthcare professionals make the right antibiotic prescribing decision, and addressing the global threat of antimicrobial resistance.”
Manos Perros, President and Chief Executive of Entasis Therapeutics Inc., said:
“At Entasis Therapeutics, we discover and develop antibacterials for the treatment of multi-drug resistant infections. Through our pathogen-targeted approach, we are building a pipeline of innovative molecules to treat patients responsibly, optimizing our experimental drugs to target some of the most urgent medical needs. We acknowledge the efforts of Lord O’Neill’s Review to build a framework of global measures which will rekindle and sustain scientific innovation, incentivise development and commercialization, and ensure access and responsible use of current and future antibacterials.”
Alexandre Mérieux, Chief Executive of bioMérieux SA, said:
“Strongly involved in the fight against antimicrobial resistance, the diagnostic industry strives to develop rapid and high medical value tests in close collaboration with healthcare professionals. Building on more than 50 years of expertise in the diagnosis of infectious diseases and its leadership position in microbiology, bioMérieux is an strong advocate for the development of innovative, rapid and beneficial diagnostics in order to facilitate the rational use of antibiotics and curb global resistance. True to our pioneering spirit, we are proud to sign this joint Declaration and place great hope in the outcomes of such an unprecedented collective call to action to protect public health worldwide for the years to come.”
Dr Habil Khorakiwala, Founder Chairman of Wockhardt Ltd., said:
“Wockhardt has over the years made focussed investments in antibiotic discovery and development, culminating in a pipeline of novel antibacterial drug candidates to effectively manage the AMR issue. Wockhardt expects governments’ help in creating a sustainable economic model for antibiotic R&D.”
Dr Yusuf K Hamied, Chairman of Cipla Ltd., said:
“The work being done by this committee is of particular relevance to India, where the overuse of antibiotics needs to be curbed.”
Radha Rangarajan, Chief Executive of Vitas Pharma, said:
“There is a dire need for novel therapies that overcome drug resistance. To support R&D today, is to save lives tomorrow.”
Daikichiro Kobayashi, President of Meiji Seika Pharma Co., Ltd., said:
“We welcome global efforts to combat antimicrobial resistant such as the activities under this declaration and will continue to struggle with the problem for public health.”
Steve Bates, Chief Executive of the UK Bio Industry Association (BIA), said:
“The ever-growing threat to world health from antimicrobial resistance cannot be tackled unless industry and governments around the world work together in new ways. It’s fantastic to see so many key organisations already signed up to the declaration and the UK innovation ecosystem has a lot to contribute to this global challenge.”
Doris-Ann Williams MBE, Chief Executive of the British In Vitro Diagnostics Association (BIVDA), said:
“The in vitro diagnostics (IVD) sector is ready to stand shoulder to shoulder with colleagues from across industry to tackle the threat of AMR to human health. IVDs have a critical role to play in preventing unnecessary prescriptions of antibiotics or accurately targeting their use. BIVDA is pleased to be supporting the Declaration and we look forward to continued collaborative work to support the AMR challenge”
Adrian van den Hoven, Director General of the European Generic and Biosimilar Medicines Association (EGA), said:
“The rational use of medicines through good prescription practice and better health literacy to ensure patient compliance with antibiotic medicines is crucial to maintain the effectiveness and availability of these life-saving treatments”
1 This reflects the final confirmed number of signatories at the time of publication, and updates the figure used in earlier versions of this press notice.
About antimicrobial resistance
Notes for Editors
This Press Release will also be available on Thursday, January 21st 2016 on www.amr-review.org/industry-declaration.
Media enquiries should be addressed to the Review on AMR team on: info@amr-review.org; and
+44 20 7611 5710 or +44 7715 426 895.
Additionally, all signatory companies may be contacted directly for comment via their own media offices or via the Review on AMR.