Factors Related to Regulatory Approval of Late-Stage Development Compounds: Analysis of Japanese Pharmaceutical Company Activities, 1995-2007.

Japanese pharmaceutical companies invest resources in their internal research and development (R&D) activities and in-licensing activities especially from Western companies, for the local market. The objective of this research is to investigate the fate of late-stage compounds developed by them and to identify company profiles and compound characteristics that could relate to regulatory approvability. Using publicly available information for late-stage compounds that were developed by Japanese companies in 1995-2007, logistic regression analysis was conducted to investigate the company characteristics and regulatory approval ratio, as well as compound characteristics and probability of approval, for late-stage development compounds. Compound approvability was correlated to the time when the compound was developed (ie, the approval ratio of compounds in phase 3 or later in 1995-1998 was lower than that in 2001 or later); also, in-licensed compounds from large pharmaceutical companies received a higher approval ratio. Company size and R&D expenses were not correlated to their approval ratio.