Commission launches second phase of Innovative Medicines Initiative

The European Commission has launched a second phase of the EU Innovative Medicines Initiative (IMI2) public private partnership, whose goal will be developing next generation medicines, notably new antibiotics able to fight ‘super-bugs’.

A total of €3bn is to be made available for the new phase, which will run from 2014 to 2024. Half of this money will come from the EU and half from the European pharma sector.

Comparing this phase with the outgoing first phase (covering 2007-13), Joe Jimenez, CEO for Novartis, said that the goals for IMI2 are more ambitious. He noted that they will push EU research and development in the right direction, ensuring medicines are better tailored for the needs of specific patients.

More specifically, IMI2 will strive to deliver a 30% better success rate in clinical trials of priority medicines identified by the World Health Organisation (WHO); generate clinical proof of concept in immunological, respiratory, neurological and neurodegenerative diseases in five years; create new and approved diagnostic markers for four of these diseases; and develop at least two new medicines that could either be new antibiotics or new therapies for Alzheimer’s disease.

The development of new antibiotics will be one of the main focuses of IMI2, according to Michel Goldman, IMI executive director. ‘In Europe about 25,000 people die every year because we don’t have the appropriate antibiotics to treat resistant bacteria,’ he said.

We are moving from the symptomatic type of medicines to trying to really understand the causes of diseases

‘We are moving from the symptomatic type of medicines to trying to really understand the causes of diseases; we are moving to a molecular treatment or prevention of those diseases,’ added Ruxandra Draghia-Akli, director of the health directorate of the European Commission’s directorate general for research and innovation.

According to Draghia-Akli, IMI2 will have a different strategic research agenda from IMI: ‘Instead of looking for new tools and technologies that could address drugs development, we are moving towards addressing public health needs,’ she explained. She stated that she expects new medicines to respond to the high public health needs, such as antibiotics, but also a drug to treat Alzheimer’s or a vaccine to prevent it. ‘This requires significant investment that is targeted to the right type of research and development.’

The contributions from members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) will be monetary and in-kind contributions. The European Commission will equally contribute with €1.5bn from its new research and development funding programme, Horizon 2020, starting next year. This will leave IMI2 with €1bn more than the first IMI budget of €2bn, although the money will have to last longer.

If in the next seven to 10 years we will have four more diseases classified, we have at least four more opportunities for economic gain for personalised medicines

A key element of IMI2 will be groundbreaking work to understand certain diseases and their causes, and then creating targeted medicines to deal with these triggers in specific patient groups. ‘If in the next seven to 10 years we will have four more diseases classified, we have at least four more opportunities for economic gain for personalised medicines,’ Draghia-Akli said, noting the advantages for the industry in participating in IMI2.

But Peter Andersen, head of EFPIA research directors group, also sees a danger that will have to be tackled as part of IMI2. For instance, say Parkinson’s disease is reclassified through IMI2 studies based on its genetic markup, effective medicines would target patients with specific genetic profiles and these population groups might not be very large. ‘We need to figure out a different business model that will allow companies to recoup the investment,’ he noted.

We are now creating a very flexible framework where other industrial partners would be welcome on board

While IMI was criticised for being a closed club, IMI2 is designed to be open to more companies, including small-and-medium-sized enterprises (SMEs), and even those in industries other than pharmaceuticals. ‘We are now creating a very flexible framework where other industrial partners would be welcome on board,’ said Draghia-Akli. For example, the imaging industry could help develop imaging biomarkers in a project looking at the various types of biomarkers involved in Alzheimer’s disease. Contributions from other industries to IMI2 could bring in an extra €225m in addition to the €3bn already on the table from the European Commission and the pharmaceutical industry, she suggested.

‘SMEs can have their inventions protected and could explore their benefits,’ Andersen said, regarding SME involvement in IMI2. They are already involved in the current IMI, according to Goldman, who noted that one SME developed the first ever human cell line for diabetes research, which will be commercialised and used by three large pharmaceutical companies.

The current initiative has funded 40 ongoing projects. According to the European Commission, IMI projects have hastened the development of diabetes drugs through the first ever human pancreatic beta cell line; new models to better predict drug toxicity; a new definition of severe asthma that promises to unlock new therapies; and the world’s largest database of schizophrenia studies to develop more targeted treatments. Moreover, research funded by IMI has created a better understanding of the mechanisms of chronic pain.