Abstract
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.
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Tsukamoto, A., Kaneko, M. & Narukawa, M. Factors Related to Regulatory Approval of Late-Stage Development Compounds: Analysis of Japanese Pharmaceutical Company Activities, 1995–2007. Ther Innov Regul Sci 47, 261–267 (2013). https://doi.org/10.1177/2168479012474274
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DOI: https://doi.org/10.1177/2168479012474274