R&D chief Moncef Slaoui

Coming to the crossroads on R&D - GSK

R&D 2012: $5.95 billion (£3.97B)
R&D 2011: $6.01 billion (£4.01B)
Change: Down 1%
As a percentage of revenue: 15%
R&D chief: Moncef Slaoui

GlaxoSmithKline ($GSK) spent just under £3.5 billion--right around $5.25 billion for those who count in dollars--for its "core" R&D work. Add in some one-time expenses, and the gross shoots up by about $700,000 more. In 2011, the figures were just a bit higher on core research costs, and only marginally higher for the full amount, adding in restructuring costs and so on.

GSK didn't have a whole lot to boast about last year. There was an approval for raxibacumab, an antibody treatment for inhaled anthrax, which was being developed for defense programs in partnership with the recently acquired Human Genome Sciences (HGS). Its main claim to fame rested on two new approvals for existing meds. That's not much when you're spending about $6 billion a year on R&D. But for the past few months now the Big Message at GSK is that 2013 will mark a turning point for the Big Pharma's research arm, the payoff for its top-to-bottom reorganization and commitment back in 2008 to become more biotech-like in the way it goes about drug discovery.

It rests much of its case on 6 therapies that have now been filed for review at the world's top regulatory agencies. At the front of the line is Breo, GSK's once-daily step up on Advair intended to save that crucial respiratory franchise. An FDA advisory panel review was slated for March 7 but was delayed by a snowstorm. In a remarkably frank interview with Dow Jones back in mid-February, though, R&D chief Moncef Slaoui conceded that Breo and the rest of the drug group under review are not going to be first-in-class drugs. A quick translation: They're going to face headwinds from competing therapies when they reach the market.       

What Slaoui--an outspoken investigator who engineered the company's big overhaul of R&D back in 2008--and the R&D team really like, though, are the drugs in late-stage development, like darapladib, a heart drug obtained from HGS and now completely under its wing following the relatively cheap takeout of HGS for $3 billion. MAGE-A3 also counts as one of the top therapeutic cancer vaccines in development.

For the record, GSK has 14 late-stage programs under way that could deliver pay dirt in the form of positive Phase III data over the next two years. For GSK to truly claim success in R&D, it's going to need to score some wins on those frontline drugs, making 2013 a crucial year for an R&D group that has clearly come to the proverbial crossroads. 

For more:
GSK's Slaoui talks up 'innovative' late-stage pipeline as regulatory reviews loom
After dismal 2012, this is a make-it or break-it year for GSK
GSK spotlights PhIII heart, cancer blockbuster hopefuls in late-stage R&D review
GSK and Theravance make progress in FDA review of key COPD drug
GSK closes the deal on Human Genome Sciences for $3B


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