Brilinta's long-delayed FDA approval yesterday should have meant party-time at AstraZeneca. After all, this blood-thinner showed itself, in head-to-head trials, to be better at preventing heart-attacks than the $8.8 billion Plavix, the number-two drug in the world. And unlike in the case of beleaguered dapagliflozin, AZ doesn't have to share Brilinta profits with anyone.
We suspect there weren't many champagne corks popping, though. FDA's nod was reluctant, to say the least, and came with a sting in the form of a boxed warning about bleeding risk and the aspirin-problem: if patients are on too much aspirin (more than 100mg per day), Brilinta ain't so brilliant. Most if not all heart patients take aspirin. And most also take host of other pills, too -- meaning that Brilinta's twice-daily dosing could be a significant turn-off.
No wonder that, despite a small share rise for AZ yesterday, the analyst reaction was muted. Jefferies' Jeffrey Holford halved his peak sales estimates for the drug to $1 billion, calling the FDA victory 'pyrrhic' and advising investors to sell. Indeed, even the $1 billion, if it's reached, won't come fast: AZ is talking about a 12-month roll-out period, given reimbursement hurdles (raised, probably, by today's planned merger of Express Scripts and Medco, giving buyers even more clout to squeeze prices) and a REMS that calls for the company to educate physicians as to the aspirin problem.
By then, generic Plavix will have flooded the U.S. market (multisource generics are expected in May 2012), providing yet more compelling reason -- cost -- for payers to dismiss, or at least disadvantage, Brilinta.
They certainly aren't embracing Effient, Lilly's blood-thinning offering, launched in 2009. Granted, that drug came with a narrower label than Plavix, and additional bleeding risk (and not only among high-dose aspirin patients). Despite some advantages over Plavix -- it doesn't share the blockbuster's efficacy problems among slow metabolizers, and can be used in conjuction with PPI drug omeprazole -- Jefferies expect Effient sales to reach only $244 million this year.
The bottom line is that Brilinta won't do much to plug the gaping, multi-billion dollar revenue hole left at AZ after the likes of Seroquel, Nexium, Symbicort, Atacand and Zomig (worth about $14 billion in 2010) lose exclusivity in 2014 or sooner. Not to mention the $5.7 billion Crestor, which goes off in 2016 but whose growth is already slowing ahead of generic competition to class-competitor Lipitor this year.
So AZ's in the same boat as Lilly: sitting there (albeit while re-organizing its R&D), faced with the harsh reality of today's pharma scene: if there's a big drug out there that works good enough, and is about to become a lot cheaper, don't bother trying to better it. Better has to be so much better these days; and safer has to be safer in all patients, not just those going easy on the aspirin.
Meanwhile in Europe (where, in those patients included in the 18,000-strong Phase III PLATO trial, the aspirin problem didn't show up), Brilique (as it's known there) is already reimbursed in seven countries (including Iceland) and the company expects decisions this year in France (following an earlier withdrawal), Germany (where it's the first to test a new reimbursement system) and the U.K, where the drug received a preliminary approval in June.