Bruce Booth, who writes an informative and insightful blog about early stage life science venture capital, posts regularly about trends within the biotech industry, and recently about expectations for 2012. It seems the primary theme from this year’s Annual J.P. Morgan conference is innovation. Before going further, this requires some analysis. Innovation, a.k.a. Novelty, means different things depending on your viewpoint.
For the VC, from whom this comment emanated, the word was qualified with reference to ‘differentiation’. It is not the same as the normal patent definition, whereby an invention ‘shall be considered novel if it does not form part of the state of the art’.
Differentiation is primarily a clinical and marketing concept, but again it has different connotations to different people. In cancer, for instance, differentiated products are often based on improved outcomes (patient survival or progression of disease). In neuroscience, innovation moves much more slowly: expect incremental improvements around tolerability or side effects. The recent introduction of Viibryd (vilazodone) exemplifies that: another SSRI but with less sexual dysfunction and weight gain.
As has been oft repeated, drug repurposing suffers from issues of differentiation. But this is only so if the pharmaceutical active is the same. Statins have anti-inflammatory properties but they have not been developed for rheumatoid arthritis because of this issue (despite clinical evidence for their efficacy). If however, a particular chemical modification could be identified that promoted the anti-inflammatory effect, there could be strong reasons to develop such a compound specifically for this new indication, where it would play in a marketplace devoid of other statins. The decision to pursue such a strategy depends on medical and marketing considerations.
There are a number of new drugs passing down the pipeline and onto the market with relatively small degrees of pharmaceutical novelty but important clinical advantages. For instance, has anyone noticed the similarity between ezogabine (approved in 2011 for epilepsy) and flupirtine, a drug used for nearly 30 years in pain?
Novelty appeals to all of us. But, just unlike the contents of Christmas crackers, small novelties should not be discarded without close inspection.