From Fierce Biotech on PhIII trials gone wrong
Top 10 Phase III disasters of 2014
By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn
Welcome to the hall of shame, where blockbuster drug projections go to die. Below you'll find some drugs that clearly should never have wound up in Phase III to begin with, a few that were actually steered back to the clinic in a doomed attempt to mine something positive after wasting millions on clinical trials and a couple of notable exceptions that may have helped advance the field by exploring the outer limits of new drug technology.
Some big trends emerge from the wreckage. Over the past year we've seen some conclusive evidence that cancer vaccines don't work very well--when used as a solo treatment. We have new evidence that cardio studies remain high cost and ultrahigh risk. And there are a couple of fresh examples of what happens to a biotech when you bet big on one Phase III--and fail.
Unlike past years, though, there's an important caveat to make. Eli Lilly ($LLY), one of the regulars on the list for the past few years, is back with a notable late-stage flop. But after some significant advances on the approval front, particularly regarding the new GLP-1 drug dulaglutide, a setback like this doesn't sting quite as much in 2014. GlaxoSmithKline ($GSK) had a slate of approvals before its two big Phase III failures, which helps. In general, you can make the case that Big Pharma pipelines have moved up a notch. And with more than $70 billion in R&D costs budgeted each year among the Big 10, that's an important sign.
But when a company like Merck KGaA has to throw in the towel a second time on a big program like tecemotide (Stimuvax), it has to make some analysts wonder if some of the larger companies still suffer from a deep-seated state of denial when it comes to pursuing false signals in the clinic. Combined with the cladrabine fiasco and a weak pipeline some years after the big Serono buyout, and you have to wonder whether all those billions were simply wasted.
-- John Carroll (email | Twitter)
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1. Darapladib -- GlaxoSmithKline
2. Tecemotide (Stimuvax) -- Merck KGaA
3. MAGE-A3 -- GlaxoSmithKline
4. Cabozantinib -- Exelixis
5. Serelaxin -- Novartis
6. Tabalumab -- Eli Lilly
7. Bitopertin -- Roche
8. Dacomitinib -- Pfizer
9. Vintafolide -- Merck and Endocyte
10. Revolixys (REG1) -- Regado Biosciences
Read more about: Exelixis, Stimuvax, MAGE-A3, GlaxoSmithKline
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