On April 22, 2022, Astellas Gene Therapies shared a press release announcing that they have made the difficult decision to stop development of AT753, AT702, and AT751.
“Patients are at the center of what we do, and we feel compelled to only develop those treatments that we feel can bring substantive benefit to their lives. However, we remain committed to the DMD community and will continue to seek a path forward to developing a treatment for Duchenne,” said Astellas.
Please note that the ASP0367 program is not impacted by this decision regarding the gene therapy programs.
TOKYO, April 22, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that it will book an impairment loss in the fourth quarter of the fiscal year ended March 31, 2022 (April 1, 2021 to March 31, 2022) and the first quarter of the fiscal year ending March 31, 2023 (April 1, 2022 to March 31, 2023) as follows.
(1) Details of impairment loss (the fourth quarter of fiscal year 2021)
For the following reasons, Astellas will book an impairment loss of approximately ¥50 billion as other expenses in the fourth quarter of fiscal year 2021 not included in the financial forecasts (Full basis) announced on October 29, 2021.
Astellas received reports of serious adverse events in patients who participated in the ASPIRO clinical trial evaluating investigational gene therapy AT132 in patients with X-linked myotubular myopathy. In September 2021, Astellas voluntarily suspended screening and dosing. After that, Astellas received the clinical hold for the ASPIRO clinical trial from the US Food and Drug Administration (FDA). Astellas then reassessed the development plan and recognized a delay in approval timing. Astellas also revised the eligible treatment population based upon an anticipated future product label compared to our initial assessment. As a result of reevaluation of the intangible asset based on the updated assumptions, Astellas will book an impairment loss of intangible assets as other expenses.
It has decided to terminate the development of the DNA vaccine ASP2390, which is currently in Phase 1 study for house dust mite-induced allergic rhinitis patients. As a result of this termination, Astellas will book an impairment loss of intangible assets as other expenses.
It has decided to terminate the development of the GITR agonistic antibody ASP1951, which is currently in Phase 1 study for cancer patients. As a result of this termination, Astellas will book an impairment loss of goodwill as other expenses.
(2) Details of impairment loss (the first quarter of fiscal year 2022)
Based upon recent preclinical study data, the research and development of gene therapy programs AT702, AT751 and AT753 for Duchenne muscular dystrophy has been terminated. As a result of this termination, Astellas will book an impairment loss of intangible assets of $ 170 million as other expenses in the first quarter of fiscal year 2022.
Regarding (1) above, the impact from this matter is not reflected in Astellas’ consolidated financial forecasts for the fiscal year ending March 31, 2022 that were announced in October 2021. In addition to (2) above, the financial impact of this matter will be included in the announcement of financial results on April 27, 2022.