Over 40% of innovative medicines recommended for marketing authorisation (MA) in the European Union (EU) during 2010-12 originated from small or medium-sized enterprises (SMEs), academia, public bodies and public-private partnerships, according to new research.
27% of medicines containing a new active substance which were recommended for MA by the EMA’s Committee for Medicinal Products for Human Use (CHMP) during the period originated from SMEs, adds the study, which has been published in Nature Reviews Drug Discovery.
However, the researchers also find that SMEs accounted for only 13% of the MA holders for these medicines.
17% of the products originated from academic institutions, public bodies and public-private partnerships, but these organisations are no longer involved at the state of MA applications, notes the study, which is authored by EMA staff members.
They also looked specifically at the origin of medicines intended for the treatment of rare diseases, and their findings show that:
• 61% of the medicines with an orphan drug designation originate from SMEs, yet these firms account for only 22% of the MA holders for the products; and
• 11% of the products with an orphan designation originate from academic institutions, public bodies and public-private partnerships - organisations which are no longer involved at the stage of MA applications.
Commenting on their findings, the authors suggest that understanding the factors that could affect drug designation, such as the nature of the organisations involved, could help in developing strategies to catalyse further advances.
‘This analysis shows that SMEs, academic institutions, public bodies and public-private institutions represent an important source of innovation and bolster the product pipelines of larger companies,” they report.
The EMA says that it recognises SMEs as “a motor of innovation” in the EU, and points to its programme, established in 2005, of supporting such companies throughout all stages of medicines development.
The programme offers fee reductions of 90% - or 100% for orphan products - for advice and services to companies which employ fewer than 250 staff, and have an annual turnover of not more than 50 million euros or an annual balance-sheet total of not more than 43 million euros.
The analysis produced by the Agency staff “underlines the importance of the support that the EMA offers early in development, which should facilitate and promote the emergence of innovative medicines,” said Melanie Carr, head of the EMA’s SME Office.