Development of new drugs originated and acquired by United States-owned pharmaceutical firms, 1963-1976.

Abstract

Thirty-nine United States–owned pharmaceutical firms provided data on all 956 self-originated or acquired new chemical entities (NCEs) that they first tested in man anywhere in the world or first filed as Investigational New Drugs (INDs) from 1963 through 1976. Data on 777 self-originated NCEs update our earlier reports and indicate a continuation of trends observed previously: the numbers of self-originated NCEs first taken into man and filed as INDs dropped in 1975–76 to the lowest levels seen, the proportion first given to man abroad continued to rise to 40% in 1976, and the time requirements lengthened. Allowing at least 5 yr, 11% of INDs on self-originated NCEs reached New Drug Application (NDA) submission and, allowing at least 2 more years, 73% of the submissions were approved. Mean durations of IND and NDA phases for self-originated NCEs approved in 1976 were 79 and 30 mo, a total of 9 yr. The proportion of INDs representing acquired rather than self-originated NCEs rose from generally under 20% to 36% in 1976. Acquired NCE INDs did not show the marked decline seen for self originated NCE INDs, and had double the chance of success: allowing at least 5 yr, 25% of the acquired NCE INDs reached NDA submission and, allowing at least 2 more years, 72% of the submissions were approved. Average durations of IND and NDA phases for acquired NCEs approved in 1976 were 27 and 26 mo, a total of 4.5 yr. Our data indicate major differences between self-originated and acquired NCEs and increasing time requirements, particularly for self-originated NCEs. Clinical Pharmacology and Therapeutics (1980) 28, 270–277; doi:10.1038/clpt.1980.160