Takeda takes $143M loss after epilepsy drug fails

In its recent quarterly results release, Takeda announced a significant JPY 21.5 billion ($143 million) impairment charge related to its rare epilepsy drug, soticlestat. This comes after the company paid nearly $200 million in 2021 to fully acquire rights to the CH24H enzyme inhibitor from Ovid Therapeutics. The charge follows disappointing outcomes from Phase III trials. The SKYLINE and SKYWAY trials, which aimed to treat Dravet syndrome and Lennox-Gastaut syndrome (LGS) respectively, failed to achieve their primary goals. Despite the LGS program being terminated, Takeda indicated that the SKYLINE trial "narrowly" missed its objectives, and the company remains cautiously optimistic about soticlestat’s potential for Dravet syndrome. Takeda believes the overall data for Dravet syndrome still points to a "clinically meaningful benefit" even though the main endpoint was not met.

In other pipeline news, Takeda has ceased its Phase III program for pabinafusp alfa (TAK-141/JR141) targeting Hunter syndrome in the EU market. This decision follows a strategic review of its partnership with JCR Pharmaceuticals, which will continue as the study sponsor for ongoing Phase III trials involving participating patients. Additionally, an early-stage trial for ponatinib in pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia was closed due to dose-limiting toxicities.

Despite these setbacks, Takeda reported robust overall performance for the first fiscal quarter, with a revenue jump of 14.1% to JPY 1.2 trillion ($8 billion). Growth was driven by its portfolio of growth and launch products, which experienced a 17.8% increase at constant currencies and now accounts for nearly half of the company's total revenue. Sales of Entyvio, Takeda's treatment for ulcerative colitis and Crohn's disease, surged by 22.1% to JPY 234.4 billion. The company's rare diseases portfolio saw a 16.8% increase to JPY 199.5 billion, helped by Takhzyro's impressive 35.6% growth to JPY 56 billion. Plasma-derived therapies also performed well, climbing by 29.7% to JPY 271.4 billion.

Milano Furuta, Takeda's chief financial officer, maintained a cautious forecast for the rest of the fiscal year, a stance unchanged since May. Furuta noted that the impact of generic erosion is expected to intensify in the upcoming quarters. He also mentioned that the company's R&D investment would be more focused on the second half of the year due to the planned initiation of multiple Phase III programs.

Earlier this year, Takeda announced a $900-million restructuring plan, which will affect 641 employees across two sites in the Boston area. This restructuring is part of Takeda’s broader strategy to streamline operations and better focus its resources on key growth areas and innovative treatments.

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