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GlaxoSmithKline's FDA batting average tops the industry; Lilly, not so much

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Reaping the benefits of deep-seated R&D reorganization, GlaxoSmithKline ($GSK) had the industry's best 6-year run of FDA nods for new drugs, according to EvaluatePharma, leading its competitors by a wide margin and leaving approval-starved outfits like Eli Lilly ($LLY) and Merck ($MRK) in the dust.

Led by its vaccines and respiratory segments, GSK won 20 approvals for new molecular entities between 2008 and 2013, topping Novartis' ($NVS) 13, Johnson & Johnson's ($JNJ) 9 and Bayer's 7. But while GSK was the most prolific, its next class of drugs likely won't be the most lucrative, EvaluatePharma figures: By 2018, GSK's new treatments will pull in $11.7 billion, a figure dwarfed by J&J's $13.1 billion and an expected $12 billion from Pfizer's ($PFE) 6 approvals.

And then there's the bottom of the list, which comes as little surprise. Eli Lilly and AstraZeneca ($AZN) won just two NME approvals apiece over that period, and the former's products are expected to bring in just $500 million in 2018, accounting for 3% of company-wide sales, according to EvaluatePharma. Merck and its three approvals are hardly more promising, with 5-year-out sales pegged at $700 million for a 2% share of product revenue, according to the report.

Quantity, of course, isn't the only telling factor. Sanofi ($SNY) racked up an impressive 6 approvals from 2008 to 2013, landing it in the middle of EvaluatePharma's list, but those drugs' 2018 sales estimates tally up to just $2.3 billion, illustrating the French drugmaker's years-long difficulties with launching new products.

The NME bottom-dwellers all face mounting pressure to improve their R&D productivity, whether by homing in on a small group of promising areas, calling it quits on moon-shot projects or spending big on innovative biotechs. And, as EvaluatePharma points out, there's no one way to amp up ROI: Of the biggest approvals over the past 6 years, only two stemmed from internal discovery operations, with the rest gained through acquisitions and licensing deals.

- read the report

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