Large Pharmaceutical Firms Are Getting More Drugs Into Development While Terminating Unpromising Candidates
July 22, 2009
BOSTON – July 22, 2009 – Large pharmaceutical firms, under pressure to bring new
medicines to market faster, have been getting more drug candidates into
development in recent years and have become more aggressive in terminating
unpromising candidates, according to a study recently completed by the Tufts
Center for the Study of Drug Development.
One in six self-originated compounds that entered clinical testing at large
pharmaceutical companies from1993 to 2004 was expected to eventually attain
marketing approval, the study found.
“Increasing the pace of new drugs entering development and terminating
candidates that are unlikely to succeed is the right combination of trends that
will help the industry counter the expected decline in revenues due to scheduled
patent expirations,” said Tufts CSDD Director of Economic Analysis and study
author Joseph A. DiMasi.
According to the study, the share of new self-originated drugs that were
terminated during Phase I and Phase II clinical testing increased from 1993-98
to 1999-04.
The study also found that the in-licensing of products into the clinical
pipelines of the top 50 firms, a practice that gained much industry attention in
recent years, reached a high point at the end of the 1990s. After peaking at 28%
for drugs that first entered clinical testing in the 1999-01 period, licensed
products as a share of the total development portfolios of big pharma dropped to
just under 16% for 2005-07.
“The decline in the share of drugs that were licensed-in at large pharmaceutical
firms likely reflects both a reinvigoration of discovery efforts and a recent
shift in licensing strategies that focuses more on the smaller number of
available late-stage compounds to help offset weak short-term growth prospects“,
DiMasi said.
The study, reported in the July/August Tufts CSDD Impact Report, released
today, also found that:
* For the top 50
global firms, the annual rate at which drugs enter clinical testing increased
31% from 1999-01 to 2002-07.
* Nearly
three-quarters of the drugs in the portfolios of the top pharmaceutical firms
that reached clinical testing from 1993-07 originated in and were developed by
the firms.
* While clinical
success rates for drugs varied widely by therapeutic class, of six specific
broad therapeutic categories analyzed, oncologic/immunologic and central nervous
system (CNS) had the greatest number of drug candidates entering clinical
testing over the 1993-07 period.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu)
at Tufts University provides strategic information to help drug developers,
regulators, and policy makers improve the quality and efficiency of
pharmaceutical development, review, and utilization. Tufts CSDD, based in
Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and
hosts symposia, workshops, and public forums, and publishes the Tufts CSDD
Impact Report, a bi-monthly newsletter providing analysis and insight into
critical drug development issues.
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Contact Email: charlene.neu@tufts.edu lowy@bus–com.com
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