For some time after the FDA put its new breakthrough therapy designation together for the industry, there was a good deal of back and forth among industry analysts over whether the BTD would make much of a difference. You don't hear much of that kind of carping much these days, and a new report from EP Vantage illustrates why.
Trimming out a single laggard, EP Vantage concludes that out of 16 BTD drugs to gain an approval, the average amount of time it took to get a regulatory green light was 5.7 months. Some of these drugs, like Novartis' ($NVS) cancer drug Zykadia, hit the mark in a mere 4.1 months, 4 months ahead of the PDUFA date. Amgen's ($AMGN) Blincyto (blinatumomab) was approved after only 2.5 months, 5 months ahead of the PDUFA date.
Just to give it a potential dollar value, think what an accelerated approval time meant for Bristol-Myers Squibb ($BMY) when it got a green light on the breakthrough drug Opdivo after 4.8 months. That drug has a peak sales estimate of more than $5 billion.
Right now the focus is on trimming delivery times down, and developers aren't just looking for some help from regulators. Every month, week or day you can eliminate from that long stretch between the bench and the bedside makes a difference for top companies, something R&D teams are acutely aware of as they get down to the red zone. And as development times on top programs are compressed, the value of sketching out manufacturing and resolving other issues early becomes a priority as well.
That's what I'll be covering in my BIO 2015 panel, which is coming up a little more than a week from today in Philadelphia. In case you haven't heard, I'm bringing together a group of R&D experts in the cancer arena to talk about how drug research has been undergoing a revolution in the clinic, with an outline of the new standards that are being created. The panel includes R&D execs from Merck ($MRK), J&J ($JNJ), Juno ($JUNO), AstraZeneca ($AZN) and GlaxoSmithKline ($GSK).
Two notes: First, if you haven't had a chance to fill out the Bloomberg Intelligence/FierceBiotech survey, which asks for your opinion on changing drug development schedules and biotech valuations, please take a minute and complete that at this link. We'll be discussing your thoughts at BIO. I'll also be polling the audience for some early suggestions for the 2015 Fierce 15, so if you have a company you'd like to suggest, we'd like to hear from you. You can even lobby me for a minute or two, if you feel particularly passionate about a biotech.
This will be our last biotech event in the U.S. this year, so if you can make it, come by and say hello. You can check it out and register here. -- John Carroll | Follow me on Twitter @JohnCFierce