Once upon a time, getting a drug approved by the FDA was an automatic green light for commercial success.  If a drug was good enough to pass muster with the regulators, it was a virtual certainty it would find favour with physicians, payers and patients.  There was no such thing as market risk for an approved drug.

But times have changed.

Today, winning a regulatory approval in any major jurisdiction is as hard as it has ever been – but garnering that approval is no longer the magic golden ticket it used to be.

Early in 2010, just ahead of the approval of Dendreon’s Provenge the industry consensus was for blockbuster impact. Yesterday, David Nierengarten of Wedbush Securities valued Dendreon at precisely zero (although the market still ascribes a value of around $500m to the company).

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RxCelerate Ltd is an outsourced drug development platform based near Cambridge, UK. We specialize in delivering an entire road map of drug development services from discovery and medicinal chemistry through to formal preclinical development and clinical up to Phase IIa. In the last five years, we have witnessed dramatic changes in the drug development …