November 13, 2001 — BOSTON, MA — While the number of new biopharmaceutical products has steadily increased during the past two decades, the time required to develop them is lengthening, according to a study recently completed by the Tufts Center for the Study of Drug Development.

“The biotechnology revolution is picking up speed and slowing down at the same time,” said Tufts Center Director Dr. Kenneth I. Kaitin. “There has been a steady increase in the number of products entering clinical development, but the process of development and approval is taking longer.”

Since 1982, clinical development times for biopharmaceutical products have more than doubled, from an average of 33 months to 68 months. During the same period, the time required for approval by the Food and Drug Administration (FDA) dropped from an average of 24 months to 15 months, but recently rose to just under 20 months, according to the Tufts Center.

“Biotechnology companies, like their pharmaceutical counterparts, face a number of factors that are leading to longer clinical development times,” Kaitin said. “These include the growing use of newer and more sophisticated technologies, the focus on increasingly complex disease indications, the demand for higher standards for characterization of product safety and efficacy, and a growing tendency to develop new products for global markets.”

Kaitin suggested that biotechnology firms could shorten total development times by working with the FDA to reduce the time spent in clinical development, but doing so without compromising high product quality standards is a key challenge.

Following are the major findings of the Tufts Center study:

— Total development times for recombinant proteins and monoclonal antibodies are similar; average clinical development time for monoclonal antibodies was 15% longer, but approval time was 40 percent shorter, compared to recombinant proteins.

— Fifty percent of all recent new products required eight or more years from the time biotechnology companies filed an application with the FDA to develop a new product until they received approval.

— Success rates for monoclonal antibodies compare favorably with those for new chemical entities.

— The more “humanlike” an antibody is, the more likely that it will receive FDA approval; humanized monoclonal antibodies have a current approval success rate of 25 percent compared to an average approval success rate of 9 percent for all monoclonal antibodies products.