Just about everyone with even a slight amount of experience in the drug development business is sensitive to the harsh realities of R&D risk. Only about one in every 10 experimental therapies to start clinical trials makes it to an eventual regulatory approval--in some disease categories the success rate is in the low single digits. Research costs have grown; timelines have stretched out.
But a regulatory approval is simply an open door to an even riskier stage: commercialization. And in recent years we've seen drug launches fall far short of the rosy expectations created by companies and the analysts who follow them. When payers balk or sales plans fizzle, some of the most promising supposed blockbusters wind up as bitter disappointments. Biotechs trying to make the transition to commercialization can end up as cautionary tales for others looking to follow the same path. Pharma, for all its deep pockets and big sales forces, often does no better. And the losers are marked down and sold off, or simply shunned by investors.
There have been some solid hits on this front. Vertex ($VRTX) quickly made Incivek a blockbuster in the hepatitis C world--even if it's now racing ahead with new products in an effort to fend off new challengers. And companies like Novartis ($NVS) and Roche ($RHHBY) have been steadily building big new drug franchises, one approval at a time.
FiercePharma thought it would be instructive to look at the worst pratfalls. Of course, every train wreck will attract its share of gawkers. The point we'd like to make here is that every example below also offers some clear pointers on how to avoid a similar snafu. Hopefully, this report will also provide a bit of context for those peak sales estimates we're treated to on an ongoing basis. Each one of the drugs you see below once inspired great dreams of big money. Each of them failed to deliver. And a number of the top blockbuster prospects now in the pipeline will wind up on future lists of drug launch disasters.