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Smaller World, Bigger Challenges

It is the time of year to reflect on 2016’s registration statistics. Unfortunately, the EMA does not publish its annual report until May or June, but the FDA has some interesting information to share (1).

The FDA approved 22 medications in 2016, which was the lowest number in a single year since 2010. In comparison, they authorised 45 news drugs in 2015, with 2014 and 2015 approvals both representing a 19-year high. The EMA compiles its statistics rather differently and the extraction of ‘new’ registrations is something of a challenge. In approximate numbers, the Agency gave approvals to 31 out of a total of 81 new medicines, but these 81 included generics and label extensions. By comparison, there were 40 new molecular entities (NMEs) in 2015 and 46 in 2014. So we may surmise that the engine generating new NMEs is slowing down in spite of continued high investment by pharmaceutical companies. According to consultancy firm Deloitte, returns on R&D investment for the top 12 pharma firms fell to a worrying 3.7% in 2016 from a high of 10.1% in 2010.

Interestingly, only 7 of the 22 NMEs approved by the FDA were small molecules excluding imaging agents, and 12 of the remaining entities were ‘biologicals’ – mainly monoclonal antibodies and nucleotides. Some years ago, the industry thought it was going to generate vast numbers of leads through combinatorial chemistry. This promise has failed to produce the new chemical entities that proceeded to registration.

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