LONDON, March 14, 2011 /PRNewswire/ --
- Major Biologic Approvals Worth $4.5bn in 2015 Omitted From Most FDA Approval Counts Last Year
- Provenge and Prevnar 13 Overlooked in Majority of 2010 Tallies
- 65 new Biologics Have Largely Gone Uncounted in the Last 12 Years
- Overall Picture of Declining R&D Productivity Unchanged
- Cost of Developing New Drugs Remains Unsustainably High
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.
For more information and in-depth analysis of this data, please see:
FDA approval counts missing a key ingredient: http://bit.ly/eH8v10
R&D productivity needs to assess quality, not just quantity: http://bit.ly/erFO6A
Cost of new drug development remains high: http://bit.ly/f3xpMu
Annual count of new drugs approved by both CDER and CBER divisions of FDA
1999-2003 2004 2005 2006 2007
Conventional NMEs (CDER) 124 31 18 18 16
CDER BLAs (pro-forma 99-03) 23 5 2 4 2
CDER total 147 36 20 22 18
CBER BLAs 19 2 8 7 8
Total New Product Approvals 166 38 28 29 26
Cont.
Total % of 12
2008 2009 2010 (99-10) Yr Total
Conventional NMEs (CDER) 21 19 15 262 69%
CDER BLAs (pro-forma 99-03) 3 6 6 51 13%
CDER total 24 25 21 313 83%
CBER BLAs 7 9 5 65 17%
Total New Product Approvals 31 34 26 378
Notes to editors
CBER: Center for Biologics Evaluation and Research
CDER: Center for Drug Evaluation and Research
About EvaluatePharma:
The research company EvaluatePharma Ltd was the first to supply reliable consensus forecasts of global drug sales and now provides standardised worldwide financial and forecast models with consensus product sales forecasts to 2016, data on R&D pipelines, licensing deals, patent risk and M&A activity. Launched in 2007, EvaluatePharma(R)Alpha offers a Net Present Value (NPV) valuation service quantifying market events and the impact on product, portfolio and company valuation including the daily online news service EP Vantage(R).
EvaluatePharma(R), EvaluatePharma(R)Alpha, and EP Vantage(R) are services of EvaluatePharma Ltd, headquartered in London, England. In North America, EvaluatePharma Ltd is represented by EvaluatePharma USA, Inc.
http://www.evaluatepharma.com
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SOURCE EvaluatePharma Ltd