New drug development by United States pharmaceutical firms with analyses of trends in the acquisition and origin of drug candidates, 1963-1979.

The average number of self-originated new chemical entities (NCEs) first tested in man by 39 United States-owned pharmaceutical firms in the 3-year period from 1977 to 1979 was 26 a year, approximately half the number investigated annually in the previous decade. Investigational New Drug (IND) Exemption filings on self-originated NCEs, but not those on acquired NCEs, were also comparatively low. Consequently, the contribution of self-originated NCEs to total IND filings fell from 81% in 1963 through 1975 to 68% in 1976 through 1979. (There was a similar decline, from 78% to 61%, in the proportion of compounds synthesized in the United States.) The relative increase in IND filings on acquired NCEs was greatest for smaller firms. By the late 1970s acquired NCEs accounted for almost 50% of the INDs filed by smaller firms, but only 10% to 25% of those filed by large and medium-sized firms. The importance of NCEs acquired from abroad has increased since the mid-1970s. The number of INDs filed on Japanese-originated NCEs rose from approximately one a year in 1963 through 1975 to an average of 3.5 a year in 1976 through 1979. Initial clinical testing of self-originated drugs abroad, which increased sharply in the early 1970s to reach a peak of 36% in 1976, declined to approximately 21% in 1977 through 1979. Self-originated drugs approved in 1977-1979 spent an average of 6 years in United States clinical testing and 2 in regulatory review, a total of 8 years from IND filing to NDA approval. The percentage of IND filings on self-originated NCEs that received New Drug Application (NDA) approval after 8 years or more was 9% overall, although ultimate success rates will be higher. There was a higher success rate for anti-infective drugs (17%) than for other pharmacologic categories (7%). For acquired NCEs, the overall approval rate was much larger (28%).