Au contraire - there have been multiple drugs that combined generics that were given FDA approval - one of them was the source of one of the worst trades of my entire life - AVNR's Nuedexta, a combo of dextromethorphan and quinidine, used to treat pseudobulbar affect (PBA), a condition that causes uncontrollable laughing or crying. After owning it for years and seeing it go nowhere, I wanted to add to my ARNA position, so I sold AVNR at $3.28, lost -15%. A year or two later they got a 2nd indication that allowed it to be used to control unruly patients in nursing homes and sales to assisted living facilities starting booming - the stuff really works for calming people down - then they got taken private for $17/shr - CRAP!! And ARNA did a 1:10 RS after that buy at $11.20 - DOUBLE CRAP! ARNA got BO by PFE last year for $100/shr for two other drugs in their pipeline, so on a net basis I lost -497% on the AVNR to ARNA lot. Did make an overall 150% profit on the BO because that AVNR lot was only 15% of my entire ARNA position - but I would made almost double that ARNA profit dollar-wise had I just held AVNR until it got BO.
Two other generic combo drugs that were in competition with ARNA's Belviq weight loss drug was VVUS's Qsymia, a combination of phentermine and topiramate, approved back around 2013, as well as OREX's Contrave, a combo of generic naltrexone hydrochloride and bupropion hydrochloride. They all flopped in the market because of bad side effects and poor efficacy. Belviq got marketing approval yanked several years ago because it was causing cancer, something that came up during the approval process that ARNA convinced the FDA was just a problem with mice, not humans - oopsie - good thing ARNA had sold the rights for Belviq to partner Eisai before that happened.
The reason all of those combo drugs were approved was because it's well known that patients will be more likely to stay on a daily regimen of a single pill vs. having to manage two - and none of those individual ingredients worked for their indication, you had to combine them to get synergistic effects to make them work. That said, I've always claimed a V-statin combo pill is a dumb idea and not worth the money it would cost to get it approved because of statin tolerability issues - everyone has a unique dose they can handle, and that applies to all the different statins - how many people will tolerate the one or two V combo pills when there are dozens of combos involved when you include all statins and all doses?
The Thought Police: To censor and protect. Craig Bruce
