REMEDi4ALL launched yesterday with the aim of making a major leap forward in drug repurposing. This promising approach to drug development consisting in the identification, testing, and validation of new therapeutic indications for existing medications, is a developing field but faces numerous barriers and systemic inefficiencies. Still, its potential to significantly bring down times and costs of drug development -it focuses on already approved, discontinued, shelved or investigational therapeutics- makes this novel strategy attractive for rare and neglected conditions, cancer, emerging public health threats such as COVID-19 or new drug combinations. It also translates into more sustainable health systems.
The REMEDI4ALL initiative will:
EATRIS, the European infrastructure for translational medicine, will lead this multidisciplinary consortium involving 24 European organisations with the common goal of making cost-effective repurposed medicines more widely available.
To advance knowledge in the field of medicine repurposing and address substantial obstacles -fragmented and siloed research; non-standardised datasets; heterogenous quality of computational tools; poor patient engagement or lack of incentives and policies to support and enhance drug repurposing- the European Union (EU) through the Horizon Europe (HE) programme will invest 23 million euros in REMEDi4ALL over the next 5 years. It is expected that, due to REMEDi4ALL, more (and better) repurposed therapeutics will be widely available thanks to more agile, cutting-edge development processes, ultimately contributing to increased sustainability of health systems.
A favourable eco-system for drug repurposing
The project kicks off with the ambition of establishing a European research and innovation eco-system that facilitates fast and cost-effective patient-centric development and access to repurposed medicines. To this end, REMEDi4ALL will:
REMEDi4ALL has selected four medicine repurposing projects in different stages of development to demonstrate the viability of the newly created platform. Each project covers a different therapeutic area with high unmet medical needs– pancreatic cancer, COVID-19, rare diseases and ultra-rare diseases. These projects will first be onboarded to ensure a patient-centric approach before testing all elements of the platform to optimise its tools and services.
A multidisciplinary effort to cover every aspect of drug repurposing
The REMEDi4ALL consortium brings together a unique combination of expertise to address the complexities of drug repurposing. Under the leadership of EATRIS, the European infrastructure for translational medicine, 24 organisations in the fields of clinical and translational research, clinical operations, patient engagement and education, regulatory framework, funding, governance, Health Technology Assessment (HTA) or pricing and reimbursement will closely collaborate to make drug repurposing mainstream.
“It’s an enormous privilege to work with this team of leading international experts, institutions and patient representatives in such an important and high potential area for European health. REMEDI4ALL will truly transform drug repurposing by making the process more transparent, efficient and – most importantly – completely patient-centred” expressed Anton Ussi, CEO at EATRIS ERIC.
The 24 partners participants include:
Links:
The Value Added Medicines Group, a sector group of Medicines for Europe, joins the initiative as a member of the REMEDI4ALL consortium. Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its member companies play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create Value Added Medicines, including repurposed medicines, by tackling patients’ needs that remain unmet to this day and delivering additional improvements to the healthcare community as a whole.
Contact & interviews:
EATRIS
Jake Fairnie
Teamit Research
Gisela Pairó
Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
In line with today European Commission’s Guidelines on a European Gas Demand Reduction Plan, Medicines for Europe urges Governments to maintain energy supply to medicines production sites in the event of energy restrictions in Europe.
Today the transitional period for the application of the Supplementary Protection Certificate (SPC) manufacturing waiver ends. The SPC manufacturing waiver will become operational and generic and biosimilar medicines companies will be able to start manufacturing in Europe for export, stockpiling, and day 1 launch in Europe.
Health systems face tremendous challenges across Europe. The management of COVID-19, war in Ukraine and high inflation rates are challenging supply chains for the most essential medicines.
Off patent medicines account for 70% of those dispensed in Europe, treating severe conditions such as cancer, auto-immune conditions, respiratory diseases, and cardiovascular disease. These medicines are clearly part of the solution for resilient health systems.
Generic and biosimilar medicines lower healthcare treatment costs dramatically and are essential for enabling access to medicines. The EU has therefore made the prompt launch of generic and biosimilar medicines a high priority objective of the Pharmaceutical Strategy for Europe. The 2022 Medicines for Europe Legal Affairs
Conference debated the much-needed reforms to ensure timely access to medicines.
Widely researched and resourced during the early stages of the COVID-19 pandemic, repurposing has shown its worth in an emergency. Facilitating repurposing beyond the pandemic promises sustainable developments and patient centric health outcomes in a range of therapy areas.
The upcoming EU pharmaceutical legislation revision is the opportunity to recognise and support the concept of Value Added Medicines, including repurposed medicines and, in doing so, to recognise the potential for Europe.
To make medicine repurposing a success we need to employ all resources at hand to connect different actors. One such connection which can uniquely be addressed by the EU is to assist academia and non-commercial stakeholders in conducting research, as well as facilitating their partnering with the industry in making repurposed medicines available to patients.
The early involvement of industry in repurposing projects opens a range of opportunities like new indications, different/adjusted delivery forms, changing dosage and combining different therapies to meet the needs of the patient community and to bring to market new treatment options in an accessible and affordable way.
The legislative framework must also foresee proportionate incentives, such as 4 years of data exclusivity and a dedicated regulatory route, which, in combination with a fit-for-purpose evaluation framework to assess the benefits, would enable Value Added Medicines (including repurposed medicines) to benefit patients in Europe. These are essential steps in recognising the investment and resources that need to be dedicated to developing a medicine based on a well-known substance.
The Chair of the Value Added Medicines Sector Group at Medicines for Europe, Arun Narayan (Viatris) commented “One of the very few solutions available to manage the early stages of the COVID-19 pandemic was to deploy wide ranging repurposing of known medicines, for those who were critically ill. While we found promising options during that emergency, there is no reason not to support this type of innovation for all disease areas. The EU significantly lags behind other regions of the world, notably the US, in supporting value added medicines with a dedicated regulatory pathway and appropriate incentives. My hope is to see this addressed in the upcoming revision of the EU pharmaceutical legislation so our industry’s capabilities may be dedicated to bringing these solutions to patients.”
Resource hub
Report – Advancing medicines repurposing in the EU, March 2022, available here.
| Medicines for Europe Communications:
Kate O’Regan koregan@medicinesforeurope.com |
The Value Added Medicines Group is a sector group of Medicines for Europe which aims at optimizing, rethinking and reinventing medicines based on known molecules and by bringing untapped innovation to improve care delivery. The Value Added Medicines Group adopts a complementary perspective compared to the other Medicines for Europe sector groups: by tackling the targeted portion of patients’ needs that remain unmet to this day, delivering additional improvement to the healthcare community as a whole.
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe, and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
The supply of medicines is critical yet unstable as war continues in Ukraine.
As a key medicines supplier, our sector is doing everything possible to support Ukrainians and welcomes the recent establishment of a more coordinated EU approach to the donation of medicines to Ukraine. We are also mobilising our logistical capabilities in close coordination with EU civil protection agencies, the Ukrainian Ministry of Health and NGOs supporting Ukrainian patients in this time of need.
Given the essential role of medicines in humanitarian situations and public health, special effort and protection is needed from European Heads of State and Government. As EU leaders meet in Brussels to discuss the evolving response to the conflict in Ukraine, we urge targeted action to facilitate safe production and transportation of medicines.
Our highest priority is to secure humanitarian corridors inside Ukraine for the safe passage of civilians and for the delivery of medicines to war-stricken cities. We deplore the military attacks on stocks of life-saving medicine and are deeply concerned about the lack of medicine for Ukrainians in the war-torn regions. We therefore plead with the EU to use all diplomatic channels with Russia to establish these vital corridors.
The EU had no choice but to apply extraordinarily strong sanctions against Russia to stop the war in Ukraine. We appreciate that medicines have been exempted for humanitarian reasons and we are working with our members to help them to comply with these important rules, notably the financial and the logistical limitations imposed by the international sanctions. There is, understandably, pressure to increase sanctions against Russia. We would therefore advise a closer dialogue between the relevant EU enforcement bodies and the medicines industry on finding the correct balance between the humanitarian need to supply medicines and the EU’s legitimate sanction policy to stop the war.
We encourage the EU Council to devote its full energy and authority to stop the war in Ukraine and to protect patients by securing access to medicines, while taking the necessary action to support our industry in achieving the same goal.
Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.