Therapeutic class determines drug development time

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Related tags: Drugs, Pharmacology, Pharmaceutical industry, Drug development

The cost and time required to develop a new drug and bring it to
market is determined by the therapeutic category of that drug. The
results are consistent with the model that predicts R&D efforts
are generally shifting toward high net return, and away from low
net return, therapeutic areas.

The study is sure to have implications on drug company's developmental costs and time constraints, while necessary to bring new drugs to market, can vary substantially from drug to drug.

Research company Tufts Center for the study of Drug Development, showed clinical period out-of-pocket costs (cash outlays occurred by a manufacturer for its R&D activities) per approved drug for analgesic/anaesthetic, cardiovascular, and central nervous system (CNS) drugs fell below the average of $282 million (€233 million). The antiinfective drugs were 28 per cent above average.

By contrast, clinical period time costs (earnings that investors forego on funds used to support R&D activities before any return can be earned) per approved drug are above average for CNS drugs, but below average for analgesic/aesthetic and antiinfective drugs.

Reducing development times, making decisions on whether or not to terminate compounds in development sooner, and increasing approval success rates can have a substantial impact on R&D costs. These are certain to be areas where many drug developers are focusing.

Clinical and approval phase times also varied by drug class, with average clinical phase times for analgesic/anesthetics, antiinfectives, and cardiovascular drugs are 36 per cent, 30 per cent, and 15 per cent below the average of 72.1 months for all drugs, respectively. Both clinical and approval phase times for analgesic/anaesthetics and antiinfective drugs fell below average times.

Average clinical phase for CNS drugs is 28 per cent above the average for all drugs. The mean approval phases for analgesic/anesthetics and antiinfectives are also below average, while those for cardiovascular and CNS drugs are above average

Kenneth I Kaitin, Tufts CSDD Director said: "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."

He added: "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."

Average worldwide sales for new drugs vary by therapeutic class, from 56 per cent below to 72 per cent above the average for different classes. The net present value for life-cycle sales for all the four categories varies widely from the average of $2.4 billion with analgesic/anesthetic 56 per cent below, antiinfective 10 per cent below, where as cardiovascular 51 per cent above and CNS 72 per cent above the average.

For drugs as a whole, antiinfective and CNS drugs, on average, have sales that peak in the tenth year following product launch with sales of $389 million and $849 million respectively. Mean cardiovascular drug sales peaked at 12 years with sales of $746 million.

Analgesic/anesthetic drugs peak, on average, at seven years after launch with $203 million. Peak-year sales for drugs as a whole was $458 million.

Related topics: Preclinical Research

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