R&D Productivity Measures Consistently Under-Scored and Under-Valued, EvaluatePharma Data Reveals

London (ots/PRNewswire) - 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

Contact:
Christian Glennie
Senior Editorial Analyst, EP Vantage
T: +44(0)20-7539-1806
E: christiang@evaluatepharma.com
Andrew Beaven
Marketing Director, EvaluatePharma Ltd
T: +44(0)20-7539-1818
E: andrewb@evaluatepharma.com
EvaluatePharma Ltd
11-29 Fashion Street
London
E1 6PX
United Kingdom

ots Originaltext: EvaluatePharma Ltd
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Contact:
Contact: Christian Glennie, Senior Editorial Analyst, EP Vantage,T:
+44(0)20-7539-1806, E: christiang@evaluatepharma.com; Andrew
Beaven,Marketing Director, EvaluatePharma Ltd, T: +44(0)20-7539-1818,
E:andrewb@evaluatepharma.com; EvaluatePharma Ltd, 11-29 Fashion
Street,London, E1 6PX, United Kingdom