Breo Ellipta - GlaxoSmithKline

No list of clinical disasters is ever complete without GlaxoSmithKline. 

The U.K. pharma giant ($GSK) has failed at virtually every major late-stage clinical study that it has mounted in recent years. All of its would-be home runs have flopped--MAGE-A3, darapladib and so on. It flopped in Duchenne muscular dystrophy, handed the drug back to Prosensa and then watched BioMarin ($BMRN) hustle it forward to regulators. An approval for Breo Ellipta was billed as one of its outstanding successes in recent years, but then it missed a crucial late-stage shot improving mortality rates for COPD patients.

Breo Ellipta was supposed to be GlaxoSmithKline's big shot at providing a successor to Advair, which is gradually expected to succumb to generic competition. Instead, it looks like a very similar drug, which will likely find few takers among payers who have an established alternative and future generics to pick from, or from patients satisfied with Advair.

GlaxoSmithKline's real dilemma, though, is that there is little left in the pipeline to give analysts reason for enthusiasm. The company swapped out its late-stage cancer effort for reliable but unexciting vaccines. And this week another one of its top prospects, the cardio drug losmapimod, also flunked out in Phase III. With eroding numbers and some big hits ahead, GSK had to dispense with any notion of spinning out its HIV/AIDS joint venture ViiV, a big earner. And the grim effort to focus on drug values instead of future blockbusters has found few advocates on Wall Street.

GlaxoSmithKline ended last year ripping up its U.S. R&D efforts to accommodate its lack of success in the pipeline. That reorg has continued to claim jobs in Europe and the U.S. With this kind of track record, there's every reason to believe that the pain will continue to be felt in 2016.

Some analysts expect Advair to face some real generic competition in the U.S. in 2017. That's beginning to look like a date with Armageddon to GSK, which has just stripped its defensive lines.

For more:
On the ropes, GlaxoSmithKline admits to another PhIII debacle
GlaxoSmithKline snags FDA approval for blockbuster COPD contender
GlaxoSmithKline gains blockbuster FDA approval of lung drug Breo
GlaxoSmithKline picks up FDA panel plug for Breo approval

Breo Ellipta - GlaxoSmithKline

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