Drug approvals show SMEs and academia are the source of most innovation

The pharmaceutical industry’s dependence on universities and small biotechs as the source of innovation is laid bare in an analysis of the origin of all the novel drugs approved by the European Medicines Agency (EMA) in the three years from 2010 – 2012.

The analysis shows that 49 per cent of the products granted marketing authorisation during this time were originally discovered by the in-house efforts of pharma companies, with the remaining 51 per cent originating elsewhere. However, of the 94 products that received approval, 87 per cent were owned by pharma companies at the point the license was granted.

The remaining 13 per cent were owned by SMEs. However, SMEs were identified as the originators of 27 per cent of the 94 drugs in the analysis. A further 17 per cent originated with academic institutions, public-private partnerships and public bodies, but none of these organisations had any involvement by the time these drugs were granted a marketing license.

The other 7 per cent of the 94 drugs originated in private-private collaborations. They also ended up in the portfolios of big pharma, according to the analysis by staff at the EMA. “This analysis shows that SMEs, academic institutions, public bodies and public-private partnerships represent an important source of innovation and bolster the product pipelines of larger companies,” the authors say. The findings, published in Nature Reviews Drug Discovery, cover only drugs that are classified as containing a new active substance, with generics and biosimilars not featuring in the analysis.

The figures provide an illustration of how difficult it is for small biotechs to raise the funding necessary to take drugs through the later stages of clinical development and onto the market, and highlight how hard it is to grow a large, independent company.

The EMA has had a programme in place to help SMEs through the process of drug development and approval since 2005. Melanie Carr, head of the agency’s SME office said the report, “underlines the importance of the support that EMA offers early in development.”

Reinforcing this support is a priority for the EMA, which says it also wants to assist academics to get involved in clinical development. The agency recently set up new structures to promote engagement with the academic world.

Burgeoning collaboration

Although they sit at the bottom end of the food chain, the analysis identifies academic institutions as a significant source of innovation, highlighting the need for pharma to forge closer ties with universities.

Indeed, the past few years has seen a clear move in this direction, with pharmaceutical companies shifting from an ad hoc, local approach, to taking a strategic, global view of relationships with academia. The specifics vary from one company to another, but cover activities ranging from sending corporate scientists to work in universities, to importing academics into corporate labs, and everything in between.

Recent partnerships include Janssen Biotech agreeing to co-fund up to 25 scientists in a drug discovery project at the Institute of Cancer Research in London; UCB Pharma entering a collaboration with the Lieber Institute for Brain Development at Johns Hopkins University in the US to jointly discover drugs for treating serious brain disorders; and the Karolinska Institutet forging a partnership with AstraZeneca to create a translational research centre for cardiovascular and metabolic diseases and regenerative medicine at the Karolinska’s site in Stockholm.

Just this week, Ireland’s public R&D funding body, Science Foundation Ireland announced a tie-up with Pfizer, in the Biotherapeutics Innovation Award Programme, a three year agreement under which funding will be available to academics in Irish universities who have novel drug targeting ideas. Pfizer researchers will work side-by-side with academic teams, to blend the research expertise of university scientists in target biology with the company’s expertise in development.

Changing hands

Such collaborations complement a surge in acquisitions and licensing deals by pharma to access new products. According to the EMA’s analysis, of the 94 products that were approved from 2010 - 2012, 55 had changed hands. The highest number of transfers was from small companies to pharma, with 18 products arriving in the portfolio of pharmaceutical companies via this route. Of these 18 products, 13 were outlicensed, while in five cases the SMEs owners were acquired during development of the drug.

There is a hint in the analysis that overall productivity in the pharma industry is improving, with 37 new drugs approved in 2011 and 36 in 2012, compared to 21 approvals in 2010.

The analysis also examined the geographic source of innovation, showing that 45 per cent of all drug originators were based in North America. In addition, transatlantic collaborations accounted for 8 per cent of new drugs approved, while 37 percent of originators were based in Europe. Japan, China, Israel and Australia were the source of the remaining 10 per cent of new drugs. There was a gradual increase in the contribution of these countries over the three years analysed, from 5 per cent in 2010, to 8 per cent in 2011 and 14 per cent in 2012.