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).
When Disraeli supposedly said “The only two certainties …More
The Cambridge Partnership is the only professional services company in the UK exclusively dedicated to supporting companies in the biotechnology industry. We specialize in providing a “one-stop shop” for accountancy, company secretarial, IP management and admin services. The Cambridge Partnership was founded in 2012 to fill a gap. Running a biotechnology company has little …