Blockbuster Potential of Next-Generation Drugs
Clinical validation of drug targets is the most difficult, expensive, and high-risk aspect of drug development. "Clinical validation" means that a potential drug target – discovered by genomic prospecting, high-throughput screening, or otherwise – leads, when modulated by a drug, to meaningful clinical benefit with an acceptable safety profile. Drug discovery and development is a graveyard of failed drug candidates because more often than not once-promising new targets turn out to have no clinical value due to lack of efficacy or overt toxicity. For this reason, a drug discovery and development strategy that uses clinically validated targets as its starting point cuts out a major contributor to overall risk and failure rates. This is the AngioDesign strategy.While it is true that next-generation drugs lack the novelty of true, first-in-class candidates, they more than make up for this by substantially de-risking the development path. Moreover, it is important to understand that next-generation drugs are not simply me-too or fast-follower drugs – true next-generation drugs are designed and engineered to embody critical new properties that substantially and meaningfully improve efficacy and/or safety. These improvements are patentable and enable the emergence of drugs that can be branded as substantial advances over the 1st generation, with commensurate reimbursement and worldwide marketing strategies. Indeed, there is every expectation that true next-generation drugs can attain blockbuster status. The following are some case studies of recent examples.