Despite Development Challenges, Drug Developers Have Reason to Be Optimistic, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (MARKET WIRE) -- January 3, 2007 -- Despite a growing list of development challenges -- including rising R&D costs, increasing regulatory stringency, and mounting public hostility over safety and end-user costs -- drug developers have cause for optimism, according to the Tufts Center for the Study of Drug Development.

Contributing to that optimism, Tufts CSDD said, is greater use of new technologies to reduce late-stage development failures and contain rising costs, increased reliance on global outsourcing to speed development and reduce costs, and more coordination between U.S. and European regulators.

The trends were cited in the Tufts Center's Outlook 2007 report on pharmaceutical and biotech development, released today.

"While drug developers have understood that their long-term viability depends on improving R&D productivity -- and have taken steps to address the issue -- they're about to see their efforts pay off in terms of improved success rates and greater numbers of new medicinal products reaching the marketplace," said Tufts CSDD Director Kenneth I Kaitin.

Kaitin cited as evidence the fact that the number of new drugs entering clinical testing by the top 10 firms increased by 52% in the first part of this decade. Also, he said, new product development at small/mid-tier pharma and biotechnology companies is increasingly filling the product gap that large pharmaceutical firms have been experiencing.

"Most notably, drug companies are improving their management of risk, especially by actively lowering late-stage attrition rates through greater use of information technology and other development practices," he said.

Other near-term trends cited in the Tufts CSDD's Outlook 2007 report include the following:

--  Companies, acting alone and in consortia, will seek to improve drug
    discovery by examining pre-competitive data to identify and validate new
    targets.
    
--  The high cost and low success rates of human studies will lead
    small/mid-tier pharma companies to adopt outsourcing and other clinical
    practices that big pharma increasingly uses to control costs and manage
    risk.
    
--  Biotech firms will escalate biodefense and pandemic disease related
    R&D, emphasizing translational research and development of effective
    countermeasures.
    
--  Instead of directly addressing off-label uses of existing prescription
    drugs, the U.S. Food and Drug Administration (FDA) will evaluate current
    studies and likely request new ones before deciding whether to further
    regulate off-label uses.
    
--  Within two to three years, up to 65% of FDA-regulated clinical trials
    for top pharmaceutical companies will be conducted abroad.
    
--  The European Medicines Agency (EMEA) will focus on implementing new
    legislation and integrating drug regulatory agencies of new European Union
    members into a comprehensive pan-European system.
    
--  U.S. third party payers will move away from a binary coverage model in
    which prescription drugs are either covered or not covered. Instead, more
    than 90% of prescription drugs will be covered with a variety of limits.
    

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.

Contact Information: Contacts: Tufts Center for the Study of Drug Development Peg Hewitt 617-636-2185 Email Contact Business Communication Strategies Peter Lowy 781-326-9980 Email Contact