Combining strengths in drug discovery and development by partnering with a medium- or large-sized pharmaceutical company increases the likelihood of success in bringing new products to the market for small companies. The drugs of small companies taken over by a medium or large pharmaceutical company, were more often approved by the European Medicines Agency (EMA) for marketing approval than the proprietary drugs from small companies. This was the outcome of a study conducted by Utrecht University, RIVM and the Central Committee on Research Involving Human Subjects (CCMO Central Committee for Research involving Human Subjects (Central Committee for Research involving Human Subjects )).
In the period 2009-2013 the EMA has assessed 172 new drugs (New Active Substances, NASs), of which 133 were approved for marketing authorisation. Forty-one percent of NASs came from small companies, including non-governmental organisations and academic institutions. This highlights the importance of small companies in drug innovation.
The study found that small companies still have higher failure percentages for MAAs — both for acquired and self-originated NASs — than larger companies. This implies that the regulatory dialogue between small companies and regulators may need improvement. Overall, collaborating with larger companies may be a more effective strategy for smaller companies to bring new products successfully to the European market.
The study was conducted within the research programme of the Dutch medicines chain and was published in Nature Reviews Drug Discovery.