FierceBiotech | John Caroll
Drug R&D is a tough business. The odds are almost always against success,
and the price to be paid for being wrong is cruelly high.
That said, it did seem a little harder than usual this year to come up with
the big disasters that always afflict biopharma's pipeline, perhaps indicating
a more coherent overall approach to drug development. But there were still
plenty of cautionary tales to choose from.
Eli Lilly ($LLY), a perennial pipeline disaster player, came up with the single biggest
flop, proving again that CETP inhibition is a poor way to go about controlling cholesterol. Now that new PCSK9 drugs have come along, there's one big Phase III CETP play left at Merck ($MRK). And then Amgen ($AMGN) will likely have some explaining to do as it proceeds with the drug it
obtained recently in the Dezima buyout.
GlaxoSmithKline ($GSK), which can ill afford R&D setbacks these days, also makes a repeat
appearance as the pharma giant continues to flounder in the face of a serious
generic threat to its Advair franchise. And then AstraZeneca ($AZN), which has been lining up multiple shots on goal, also still has to
explain the big reversal on brodalumab just as it was seeking out major regulatory approvals.
Biotechs make a bigger appearance on the list this year compared with past
lineups. In part, that's because a wave of IPOs over the past three years has allowed more small developers to stay in the
game through Phase III. For these companies, like Celladon ($CLDN), a flop can wind up threatening the company's
existence.
But as we said, this is a hard business.
You can expect plenty more R&D disasters ahead. While there's a good
case to be made that researchers are being smarter about what they put into
Phase III--and fields like oncology are able to better manage safety issues
while looking for gains on survival--no one repealed the rules around risk.
Perhaps Murphy's law has less to do with drug development than in the past, but
even the best and brightest in the business know just how uncertain it is when
you roll the dice on a clinical trial.
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