Personalized Medicine to the Rescue

The story of pharmacogenomics has reached the mass media, a.k.a. the Wall Street Journal, as a means of stemming the tide of failed drug candidates beleaguering the pharma industry. The article cites drugs from Novartis AG, NitroMed, and Clinical Data that have saved drugs that had, or would have, failed to make it to market by targeting patient sub-groups based on genotype.

Of significance in the article is stating that the pharmaceutical blockbuster model is dead and that personalized medicine may represent the new paradigm. There are in fact upsides to the smaller markets that personalized medicines command, i.e. high switching costs. With a "one-size-fits-all" drug a patient can move from one medication to another with just a trip to the pharmacy, but when using a drug is customized to a patient’s genotype, switching to a drug that is known to be less effective will be a non-starter.

One local Colorado play that illustrates the resurrection of a "failed" drug is the in-licensing of bucindolol by ARCA Discovery. Although an earlier Phase III clinical trial of the drug was terminated due to lack of efficacy, evidence has shown that certain patient sub-groups that exhibit specific genetic polymorphisms can benefit from the use of the drug.

Although the NIH Roadmap Initiatives that promoted personalized medicine and biomarker approaches four years ago weren’t mentioned in the article, the cause has been taken up by the pharmas as a new way to fill those emptying drug pipelines.