-- During the 2000s, orphan products comprised 22% of all new molecular entities (NMEs) and 31% of all significant biologics (SBs) receiving U.S. marketing approval. -- Orphan products receiving priority review status rose from 35% of all orphan NMEs in 2000-02 to 50% in 2006-08; during the same time the share of orphan SBs receiving priority review status rose from 17% to 67%. -- While biotech firms during the 2000s garnered, on average, about one-third of all orphan drug approvals, they received just over 50% of orphan drug designations. -- Sponsors engaged in clinical development funded through orphan grants reported that 22% of their programs led to approvals, which compares with a clinical approval success rate of 16% among mainstream drug developers.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, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
Contact Information: Contact: Tufts Center for the Study of Drug Development Peg Hewitt 617-636-2185 Business Communication Strategies Peter Lowy 617-734-9980