What are the origins of innovative medicines in the EU?

Posted: 12/02/2014

Staff members of the European Medicines Agency (EMA) have published, in an article in Nature Reviews Drug Discovery, some interesting findings from research that they have carried out covering the years 2010 to 2012.

The authors identified all the medicines containing a new active substance that were recommended for marketing authorisation between 2010 and 2012 by the Agency’s Committee for Medicinal Products for Human Use (CHMP). They then analysed the profile and geographical origin of the organisations at the origin of their development.

The main findings are:

• 27% of these medicines originate from SMEs, while SMEs account for only 13% of the marketing-authorisation holders;
• 17% originate from academic institutions, public bodies and public-private partnerships, while these organisations are no longer involved at the stage of marketing-authorisation applications.

The authors also looked specifically at the origin of medicines intended for the treatment of rare diseases. Their findings show that:

• 61% of the medicines with an orphan designation originate from SMEs, while SMEs account for only 22% of the marketing-authorisation holders;
• 11% of the medicines with an orphan designation originate from academic institutions, public bodies and public-private partnerships, while these organisations are no longer involved at the stage of marketing-authorisation applications.

The EMA has a programme in place to support SMEs throughout all stages of medicine development and these findings are a testament to the support provided.  The EMA says that reinforcing the support available to SMEs and acting as an enabler of development for the smaller actors in the pharmaceutical innovation ecosystem, particularly academia, is a priority.

The findings also demonstrate how important the work carried out by OBN (of which this firm is a founder sponsor) and technology transfer offices such as Isis Innovation and Imperial Innovations is in bringing new medicines to the market. The findings should also provide an incentive for those investors who support earlier stage life sciences companies.

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