martes, 11 de febrero de 2014

2014 Biggest Launches (I) _ EvaluatePharma / Del blockbuster al “nichebuster”

Only three drugs slated to be launched this year will achieve blockbuster status by 2018, according to EvaluatePharma’s consensus, a disappointing projection considering at least six blockbusters-in-waiting reached the market every year for the last four. Not all of these reached this billion dollar threshold, of course – for example, 2010 saw the launch of the spectacular disappointment Provenge. But today’s comparatively sedate view of the potential of coming launches makes a stark counterpoint to the stock market’s exuberance. 

The industry’s move towards so-called “nichebuster” drugs could help explain some of the migration, and these drugs are often in the orphan indications that deliver greater return on investment than their primary-care counterparts. And 2013 saw the launch of 10 new molecules forecast to become future blockbusters, including Gilead’s Sovaldi and Biogen Idec’s Tecfidera – a stand-out year for future earnings potential. Yet billion-dollar drugs remain an indicator of the sector’s productivity, and their absence in the 2014 launch class is an indicator that should be watched closely.

Novartis’ RLX030, known variously as serelaxin or relaxin, comes tantalisingly close to a blockbuster forecast, with $903m in sales expected in 2018. There is a great deal of uncertainty about whether this intravenous medication will be launched this year; it is a recombinant form of a natural hormone that becomes elevated during pregnancy that Novartis has developed as a treatment for acute heart failure. A negative opinion from European regulators in January did not come as a huge surprise considering that trial data had been equivocal about its efficacy. However, the project has earned FDA breakthrough therapy designation, so the US agency might be favourably inclined to approval.

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More certain to become the blockbusters of 2014 are GlaxoSmithKline’s combination COPD therapy Anoro Ellipta, Lundbeck’s Brintellix and Celgene’s psoriatic arthritis drug apremilast. (Más)

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