Risks Related to New Drug Development: Approval, Additional Costs and Recovery of Investment
First written in FY2018. 7 of 10 entries say "Restated". Latest entry: FY2023.
Yakult Honsha moved to the "Worse" side of this theme in 2022.
The whole theme swung hardest in 2018: 1 of 6 companies on the "Worse" side.
0 other companies' latest entry also says "Materialised".
- FY2023MaterialisedAnnual report
「Based on this, the Company discontinued the domestic Phase II clinical trial in follicular lymphoma and the domestic Phase II clinical trial in adult T-cell leukemia/lymphoma.」
Following the withdrawal of the duvelisib approval application, an event occurred in which the related domestic Phase II clinical trials were discontinued. - FY2023-Q3RestatedAnnual report
「Meanwhile, in research and development, the Company advanced the clinical development of pipeline products including the HDAC inhibitor resminostat, which it licensed from 4SC AG of Germany.」
The Company continues clinical development of pipeline products including resminostat. - FY2023-Q2MaterialisedAnnual report
「The Company had applied for marketing approval of duvelisib for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, but withdrew the application on 28 September following consultations with the regulatory authorities.」
The Company describes the withdrawal of the approval application as an event in which the risks of obtaining approval for a drug and recovering investment in pharmaceutical development materialized. - FY2022-Q3RestatedAnnual report
「In research and development, the Company advanced the clinical development of development products including duvelisib, the PI3K inhibitor licensed exclusively from Secura Bio in the United States for development and commercialization in Japan, and resminostat, the HDAC inhibitor licensed from 4SC in Germany.」
The Company continues clinical development of pipeline products including duvelisib and resminostat. - FY2022-Q2RestatedAnnual report
「In research and development, the Company advanced the clinical development of development products including duvelisib, the PI3K inhibitor licensed exclusively from Secura Bio in the United States for development and commercialization in Japan, and resminostat, the HDAC inhibitor licensed from 4SC in Germany.」
The Company continues clinical development of pipeline products including duvelisib and resminostat. - FY2021RestatedAnnual report
「The Company is conducting an international Phase II clinical trial of the HDAC inhibitor resminostat, licensed from 4SC AG of Germany, in patients with cutaneous T-cell lymphoma.」
The Company continues clinical development of resminostat, duvelisib and other pipeline products. It also continues to describe development costs before new drug approval, additional trials, launch delays and the risk of failing to recover investment. - FY2021-Q2RestatedAnnual report
「Meanwhile, in research and development, the Company advanced the clinical development of pipeline products including the PI3K inhibitor duvelisib, for which it has an exclusive license agreement with Verastem, Inc. covering development and commercialization in Japan, and the HDAC inhibitor resminostat, which it licensed from 4SC AG of Germany.」
The Company continues clinical development of pipeline products in oncology and related areas, including duvelisib and resminostat. It states that the transfer of rights to duvelisib has not changed its rights or contractual terms in Japan. - FY2020RestatedAnnual report
「Pharmaceutical research and development requires substantial expenditure. If, during the process, it is determined that a drug does not meet the efficacy or safety requirements necessary for approval, development may be abandoned, in which case the Company may be unable to recover the costs invested.」
The Company continues to identify the risk that investment will not be recovered due to failure to obtain approval for a new drug, higher costs and launch delays resulting from additional trials, and failure to achieve sales targets after launch. - FY2019RestatedAnnual report
「Pharmaceutical research and development requires substantial expenditure. If, during the process, it is determined that a drug does not meet the efficacy or safety requirements necessary for approval, development may be abandoned, in which case the Company may be unable to recover the costs invested.」
The Company continues to identify the risk that investment will not be recovered due to failure to obtain approval for a new drug, higher costs and launch delays resulting from additional trials, and failure to achieve sales targets after launch. - FY2018First statedAnnual report
「Pharmaceutical research and development requires substantial expenditure. If, during the process, it is determined that a drug does not meet the efficacy or safety requirements necessary for approval, development may be abandoned, in which case the Company may be unable to recover the costs invested.」
The Company describes the possibility of being unable to recover research and development investment due to failure to obtain approval for a new drug, higher costs and launch delays resulting from additional trials, and failure to achieve sales targets after launch.