A multi-billion-euro partnership between the EU and the pharmaceutical industry in Europe plans to target the top diseases, as identified by the World Health Organization (WHO), over the next decade.
We haven't had a new class of antibiotics since the late 1980s, and during that time multi-resistant germs - so-called 'superbugs' - have become a significant health threat.
On top of that, Alzheimer’s is the most common form of dementia and about seven million people in Europe suffer from the disease, according to an EU study published in 2009.
These are among the top threats to health identified by the WHO in its 2013 report.
Now, the proposed EUR 3.45 billion Innovative Medicines Initiative 2 (IMI2) aims to tackle key diseases identified by the WHO, which also include heart disease, pandemic influenza and depression. IMI2 hopes to give Europe a fast-track to having better medicines in immunological, respiratory, neurological, and neurodegenerative diseases, and to make clinical trials more effective.
‘We’re looking for the high-hanging fruit rather than low-hanging fruit,’ Dr Ruxandra Draghia-Akli, Director of the Health Directorate at the European Commission’s Directorate-General for Research and Innovation, said. ‘We expect new medicines to address issues of very high public health needs, be it a new antibiotic, be it a drug or a vaccine for Alzheimer’s.’
The EU will put up to EUR 1.725 billion into the ten-year IMI2 to help develop new drugs and vaccines, and industry has pledged to match that amount. It’s one of five so-called Joint Technology Initiatives (JTIs) that will be funded through the EU’s Horizon 2020 research and innovation programme, which runs from next year until 2020.
‘We’re looking for the high-hanging fruit rather than low-hanging fruit.’
Ruxandra Draghia-Akli, Director of the Health Directorate at the European Commission’s Directorate-General for Research and Innovation
The first IMI, launched in 2007, has fostered 40 projects and worked with 4 000 researchers from across the industry-academia spectrum. It can boast several successes, including advances in how autism is understood, how medicines for depression are developed, and how drug side-effects are detected.
‘The IMI has been like a form of life support for the few companies that have stayed engaged in developing new antibiotics,’ Richard Bergström, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said.
One example of how these projects can be mutually beneficial is the Innovative Medicines Initiative for Diabetes (IMIDIA) project, where scientists from French company Endocells developed a human cell line for diabetes research that is now being used by three large pharma groups.
The idea behind these partnerships is to give drug developers the help they need such as access to databases and expertise, and to stimulate collaboration between large pharma groups, universities, public laboratories, innovative small companies, patient groups and regulators. That should mean more efficient drugs for Europeans, easing the burden on Europe’s public healthcare systems.
Private investors are often unwilling to take on the risk of investing in early-stage drugs, while the cost of developing new drugs has risen. On top of that, red tape and the lack of proven criteria for new drug treatments in Europe mean that governments are often slower to adopt new medicines, drug companies say.
‘The costs of developing new interventions are soaring,’ said Dr Draghia-Akli. ‘We have been working in compartments with each of us incurring significant costs.’Dr Ruxandra Draghia-Akli, Director of the Health Directorate at the European Commission DG Research and Innovation.
For antibiotics, the situation is even trickier. Drug-resistant superbugs are increasingly prevalent in hospitals and nursing homes and kill thousands of people every year. However, the reward for a company that develops a new super-antibiotic would be slim: governments would prefer to keep such a weapon in reserve fearing that otherwise bacteria could also grow resistant to it.
‘We need to build bridges between academia and industry so we can focus on major unmet public health needs,’ said Michel Goldman, Executive Director of the Innovative Medicines Initiative.
While the major private sector partner in IMI is EFPIA, the initiative has built-in flexibility which leaves scope for the participation of other players such as the medical imaging or diagnostics industries.
There is also a significant involvement of small and medium-sized enterprises (SMEs). More than 20 % of the budget is earmarked for smaller firms, many of whom are attracted to IMI projects by the opportunity to work with larger companies.
Diabetes is one of a number of chronic diseases which is affecting growing numbers of Europeans, imposing a significant social and economic cost. It is the fifth leading cause of death worldwide, affecting around 336 million people around the globe, and that figure is expected to rise to 554 million by 2030.
People with so-called Type 1 diabetes have elevated blood sugar levels because the beta cells in the pancreas fail to produce enough insulin – a hormone which normally keeps blood sugar in check. The most common form of the disease, however, is Type 2 diabetes. In this case cells do produce insulin, but the body fails to use it properly.
Patients are at risk of serious complications including heart disease and stroke, as well as damage to the blood vessels, kidneys and eyes. There is currently no cure and treatment options are limited.
One of the biggest challenges that diabetes researchers have faced is the lack of a pancreatic beta cell line that could survive – and be studied – in the laboratory. Now the IMIDIA project, funded under the first IMI, is helping to unlock new avenues of research.
As part of the project, scientists from French SME Endocells have developed the long sought-after human pancreatic beta cell line that behaves in much the same way as beta cells in the body. This is seen as a genuine breakthrough for diabetes research and could pave the way for future therapies.
IMI also funds SUMMIT, a project focused on addressing the need for new treatments for complications of diabetes such as eye, kidney, and blood vessel problems. Separately, the DIRECT project is working to identify different varieties of diabetes so as to open the door to diabetes management based on personalised medicines.
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