Diseases of the central nervous system (CNS) offer considerable opportunity to drug developers and marketers. A few CNS markets, such as multiple sclerosis, are already highly competitive, whereas others including potential blockbuster areas like Alzheimer’s disease offer a kind of therapeutic whitespace where few if any drugs are approved, and the medical need is dire.
Regardless of the level of competition in a specific therapeutic area, there remains significant unmet medical need in virtually all CNS disease areas. Drug discovery and development have proven exceptionally difficult in this space, but better disease categorization and diagnosis – through the use of genetic markers or imaging technology, for example – may improve success for CNS drug developers.
The field has proven so challenging in the past that many larger companies exited CNS drug development. Companies that have remained active in CNS and others that are rejoining the fray argue that the space is poised for a breakout. Is CNS now where oncology was 10 years ago? Here we will review dealmaking in the CNS space, to determine what kinds of assets are being pursued by the biopharmaceutical industry, whether dealmaking has intensified over the past five years, and in what particular areas of CNS companies are focusing their deal dollars.
According to an analysis of US Food and Drug Administration (FDA) data, only 12 therapeutics were approved for CNS indications between 2012 and 2016, compared with 19 during the prior five-year period. Putting that figure in additional context: during 2012–16, the FDA approved 50 new oncology therapies, compared with 24 from 2007–11. Moreover, the CNS space (including pain and psychiatry) was the only major therapeutic area to see a decrease in approvals from the 2007–11 period to the 2012–16 period. Even relatively moribund and generic-dominated therapeutic areas like respiratory and cardiovascular diseases enjoyed an uptick in FDA approvals.
This lack of new therapies within the CNS area presents significant opportunities for the biopharmaceutical industry.
The source for the deal data used in this report is Informa’s Strategic Transactions.
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