The big question right now in biopharma is where real innovation is coming from, and nothing says innovation quite like a blockbuster sales estimate on a high-profile, late-stage program with some near-term potential for approval.
In recent years it's been the big biotechs in the U.S. which have registered approvals for the drugs most likely to succeed on the market. But in reviewing EvaluatePharma's recent picks for top Phase III drugs, it's interesting to see some prominent positions among the Big Pharma crowd.
Novartis ($NVS), which has earned 5 "breakthrough" drug designations at the FDA, appears twice on this list of the top 15 late-stage therapies. That matches Roche ($RHHBY), which is continuing to see major success in the cancer field while intriguingly also seeing progress at Genentech with a new drug for dry, age-related macular degeneration.
What stands out, though, is the return of some big players which have been struggling to regain some long lost respect in the field. Merck ($MRK), long absent from these kinds of lists, arrives near the top by virtue of its PD-1 checkpoint inhibitor program for pembrolizumab. That's a testament to the success of R&D chief Roger Perlmutter, who has also been drawing positive attention for the company's late-stage efforts on hepatitis C.
It's no surprise that Sanofi ($SNY), meanwhile, muscled its way onto the list by virtue of its partnership with Regeneron ($REGN). And even AstraZeneca ($AZN) makes an appearance, jumping into contention for a starring role in immuno-oncology. Pfizer ($PFE)--now struggling in R&D--made it for a big cancer program for palbociclib, now headed to the FDA in search of an early approval.
Then there are the big biotechs like Biogen Idec ($BIIB), which is continuing to command a leading position in multiple sclerosis. But it's also no surprise that Bristol-Myers Squibb ($BMY) sits on top this year, succeeding Gilead ($GILD) and Sovaldi, which enjoyed the biggest (even if most controversial) launch of a new drug in industry history.
Then there are the notable absences from the list. Eli Lilly is not in the top field of contenders, concentrating heavily on diabetes drug hopefuls which are likely going to face an uphill climb in gaining market share. And GlaxoSmithKline, suffering from a lack of home run swings after its most daring programs foundered in the clinic, is also missing in action.
There were definitely a couple of surprises--for me at least. But then all top-whatever lists are inherently subjective. One analyst's blockbuster is often on another analyst's list of train wrecks waiting to happen. Lack of uniformity is what makes these lists fun. I'd encourage you to register your own thoughts in the comments section.
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EvaluatePharma came up with the drugs and 2020 sales estimates, along with an estimate of the therapy's "net present value." The commentary is all FierceBiotech and EP shouldn't be held accountable for that. -- John Carroll, editor-in-chief (email | Twitter)