SOURCE: Tufts Center for the Study of Drug Development

May 08, 2006 09:00 ET

Big Pharma May Be Emerging From R&D Productivity Doldrums, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (MARKET WIRE) -- May 8, 2006 -- Top U.S. drug companies have increased the number of new clinical trials by more than 50 percent since 2002, signaling a possible resurgence in R&D productivity, according to a new study released today by the Tufts Center for the Study of Drug Development.

During 2003-05, the rate at which the 10 top selling U.S. drug companies initiated clinical trials for new drug candidates rose by 52 percent, following a 21 percent decline from 1993-97 to 1998-02, the analysis found.

The results were reported in the May/June Tufts CSDD Impact Report.

"This robust improvement could be the start of a break-out from the R&D productivity doldrums that has plagued the major research-based pharmaceutical companies in recent years," said Tufts CSDD Director Kenneth I Kaitin.

"The real proof will be in the ability of companies to avoid late stage development terminations and boost overall clinical success rates. Prior to the 2003-05 period, clinical approval success rates increased modestly. It remains to be seen whether further improvement in success rates will apply to the recent crop of products entering clinical testing."

That fuller picture won't be known for several years, since, according to Kaitin, average clinical phase time for new drugs receiving market approval in the U.S. is 7 years. Clinical approval success rate refers to the share of investigational new compounds entering clinical testing that eventually receive marketing approval from the U.S. Food and Drug Administration.

Coincident with the increase in new clinical trials, the largest drug companies expanded their reliance on licensed-in compounds. According to the study, the share of licensed compounds in the development portfolios of leading firms increased from approximately one in seven in 1993-97 to one in four in 2003-05.

"Big pharma is moving aggressively on a number of fronts to improve R&D productivity," said Joseph A. DiMasi, director of economic analysis at Tufts CSDD and principle investigator on the study. "Licensing in compounds to broaden and strengthen development pipelines is one stratagem that complements other efforts, including co-development agreements between large and small firms, clinical outsourcing, and use of web-based and other e-clinical technologies."

The Tufts CSDD study also found that:

--  Of six specific broad therapeutic categories analyzed,
    oncology/immunologic and CNS had the greatest shares of new drugs entering
    clinical testing during the 1993-02 period.
    
--  Respiratory, oncology/immunologic, and systemic anti-infective drugs
    had the highest clinical approval success rates for the 1993-02 period,
    while gastrointestinal/metabolism, CNS, and cardiovascular drugs had the
    lowest.
    
--  Approximately 20% of self-originated new drugs that enter clinical
    testing received U.S. marketing approval.
    
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 on related topics, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues.

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