Let's start with the large print. In the past, when I assembled lists of the biggest blockbusters in the late-stage pipeline, I sometimes just looked for the largest peak sales estimates and went with them, including some extraordinarily high risk/high reward drugs where developers were simply rolling the dice on the outcome.
That explains how drugs like solanezumab and bapineuzumab appeared--even though I had little actual faith that they would turn in positive data. (They didn't.) Some bloggers went so far as to write about it, sagely noting their risks and wondering how many of those drugs would cross the finish line.
That was a mistake. Some analysts would put a peak sales number on fairy dust; or pump up the billions in the sales column to make a client look better. FiercePharma Editor Tracy Staton and I helped underscore that last fall with a roundup of 10 cautionary tales of blockbuster busts. And I find myself repeating that mantra now just about every day.
This year, I'm stepping back and recalibrating. Some drugs are far too speculative to include on any list of prospective game changers. Solanezumab, back in a new Phase III study, is on the lottery list. If Eli Lilly's ($LLY) continued willingness to invest vast sums of money working on a disease that remains a medical mystery eventually pays off, its revenue will outshine that of many if not all of the drugs you'll find below. So far, though, the pharma company has missed time and time again on Alzheimer's. Semagacestat, solanezumab, the decision to buy Amyvid--a diagnostic imaging agent that accomplishes … what?--helps make Lilly look quixotic, at best, which it insists against all appearances is not the case.
Eli Lilly, though, does make the grade here with dulaglutide, a diabetes medication that has some major league potential. I still have plenty of questions about safety and so on that could scuttle the program. Like many Big Pharma developers, Lilly is quite picky about what it will and will not talk about. And when its top execs do talk, reality often flies right out the window. But there's a case to be made here.
In drug development, everything's a gamble, if you're doing something new and shooting at a big target. But there has to be a reasonable assumption that if safety issues aren't being glossed over and the efficacy data hold up, these top drugs can change standards of care and grab market share.
To qualify for this list, the program has to be a new entity, never approved. I may fudge that a bit when I talk about some of the possible combos in the pipeline, but I'm not looking for the biggest new expanded approvals on the slate.