EvaluatePharma data shows poor R&D productivity measures both in quality, quantity

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Pharmaceutical R&D productivity is consistently undercounted. Most reports fail to fully count the number of new drugs that reach the market, missing out on billions of dollars of sales generated by R&D investment, an analysis of EvaluatePharma data shows.

Most counts of FDA new drug approvals in 2010 failed to include likely blockbusters Provenge, a prostate cancer treatment, and Prevnar 13, a pneumococcal vaccine, because they were approved by the regulator's biologics division, CBER. As a greater number of high-value biologicals will be processed by CBER in the future, it is an omission that needs addressing to provide a more accurate reading of R&D productivity.

"With such intense scrutiny of pharmaceutical productivity at the moment, FDA approval rates are an important number to get right," says Dr Jonathan de Pass, chief executive of EvaluatePharma. "Approvals by CBER are only going to become more important in the future, with advances in areas like gene therapy and the significant investment going into improved haemophilia therapies, for example."

Including the CBER approved products lifts last year's tally to 26. Most reports, which only look at the regulator's CDER division, cited 21 new approvals, underscoring that happens annually, the data shows.

Unfortunately, this upgraded analysis does not improve the overall picture of declining R&D productivity. At the same time, the cost of developing new drugs continues to climb, the data reveals, emphasising the importance of efforts across the industry to improve returns on R&D investment.

Look at quality as well as quantity

Although 2010 was widely viewed as disappointing because of a shrinking number of drug approvals, sales forecasts reveal last year's crop could be one of the most valuable since 2004 - a bumper year which brought the industry Avastin, Spiriva, and Lyrica.

Fifth-year sales in the US of new products approved last year could reach $11.6bn, a significant improvement on the value of new products approved over the last five years. Indeed, the outlook for 2011 suggests further improvement in the quality of new drug approvals.

"Focusing on the annual quantity of new drug approvals is only half the story - looking at the quality of these products can paint a very different picture of R&D productivity", says Dr de Pass.

SOURCE EvaluatePharma Ltd

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