RARE Daily

Astellas Drops Gene Therapy Programs, Writes Off Another $560 Million

April 25, 2022

Astellas Pharma said that it will book an impairment loss of $560 million spread through the fourth quarter of the fiscal year 2022 ended March 31, 2022 and the first quarter of the fiscal year 2023, dropping several gene therapy programs that target rare diseases, a vaccine program, and an oncology program.

The write-off comes one year after the company wrote off $532 million as a result of a clinical hold the U.S. Food and Drug Administration placed on its experimental gene therapy for the rare neuromuscular condition X-linked myotubular myopathy in June 2020 that was eventually lifted in December. The clinical program had been beset by several adverse events, including the death of four patients.

In detailing the write-offs, Astellas said that the company 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, the company voluntarily suspended screening and dosing. After that, Astellas received the clinical hold for the ASPIRO clinical trial from the U.S. Food and Drug Administration. Astellas then reassessed the development plan and recognized a delay in approval timing. The company 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.

Astellas has also decided to terminate the development of three gene therapy programs for Duchenne muscular dystrophy based on preclinical data, and two programs in phase 1 development—the DNA vaccine ASP2390 for house dust mite-induced allergic rhinitis patients, and the GITR agonistic antibody ASP1951 for cancer patients.

Astellas said it would provide more detail when it reports full year results at the end of April. These write downs—more than $1 billion—are a blow to its aspiration to become a player in gene therapy after it paid $3 billion to acquire gene therapy developer Audentes at the end of 2019.

Author: Rare Daily Staff

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