Therapeutic Class Is a Critical Determinant of Drug Development Cost and Time, According to the Tufts Center for the Study of Drug Development

[Tufts Center for the Study of Drug Development via BizWire]

BOSTON--(BUSINESS WIRE)--April 29, 2004--The cost and time
required to develop a new drug and bring it to market is directly tied
to the therapeutic category of that drug, according to a study
recently completed by the Tufts Center for the Study of Drug
Development.
Summary findings of the study, which were released today, show
that analgesic/anesthetic drugs were the least costly to develop,
requiring an average of $375 million for total out-of-pocket and time
costs. This compares to an average of $466 million for all drugs, when
phase attrition rates and clinical approval success rates are factored
in.
The most expensive category of drugs to develop includes medicines
that treat diseases of the central nervous system -- known as CNS
drugs -- which cost an average of $527 million.
These figures exclude non-clinical research and development costs.
The Tufts CSDD study examined four categories of drugs:
analgesic/anesthetic, antiinfective, cardiovascular, and CNS.
Total time required for clinical and approval phases for the four
categories of drugs also varied widely by therapeutic class.
Analgesic/anesthetic drugs required an average of 61.8 months,
according to Tufts CSDD, while CNS drugs required an average of 114.6
months. Average clinical and approval phase time for all drugs was
90.3 months.
The analysis also found that average worldwide sales for new drugs
showed considerable variability by therapeutic class -- from 56% below
the average for analgesic/anesthetic drugs to 72% above the average
for CNS drugs.
"Given the dynamic nature of pharmaceutical markets and changes
over time in R&D strategy, our findings are consistent with a model
that suggests R&D efforts have generally shifted toward high net
return, and away from low net return, therapeutic areas," said Tufts
CSDD Director Kenneth I Kaitin.
He added, "The challenge for drug developers is to reduce
development times and terminate unpromising compounds earlier in
development. Because these actions help improve success rates, they
can have a substantial impact on R&D costs."

Following is a summary of key findings from the study:

Total Average Total Average Average NPV
Clinical Period Development Total Sales
Costs for Approved Time per 1990-94
New Drugs Investigational Drug
(Millions of $) (Months) (Millions of $)

Analgesic
/anesthetic 375 61.8 1080
Antiinfective 492 63.0 2199
Cardiovascular 460 82.0 3668
CNS 527 114.6 4177

All Drugs 466 90.3 2434

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. Based in Boston, the Tufts Center conducts a
wide range of in-depth analyses on pharmaceutical issues and hosts
symposia, workshops, and public forums on related topics.