Takeda is registering a JPY $21.5 billion ($140 million) impairment on its Ovid-licensed epilepsy drug in light of negative Phase 3 results, the Japanese drugmaker disclosed in its latest quarterly update.
The setback came as Takeda reported $7.5 billion in quarterly revenue and absorbed JPY $40.9 billion ($270 million) in restructuring costs associated with the company-wide “efficiency program” announced in May. It also plans to launch multiple Phase 3 trials for other assets in fiscal year 2024, which ends in March 2025.
In June, the company announced that the enzyme therapy soticlestat “narrowly missed” the primary endpoint in a Phase 3 study in Dravet syndrome and failed the primary endpoint in another study for Lennox-Gastaut syndrome.
While it continues to say it will take the data from both studies to regulators to discuss next steps, a closer look at its filings suggests the two programs don’t carry equal weight. In an investor presentation, Takeda said soticlestat “failed to demonstrate clinical benefit in LGS” whereas the “(t)otality of Dravet syndrome data suggests clinically meaningful benefit despite missing Phase 3 primary endpoint.”
Its financial report described the LGS program as discontinued and noted a “full impairment of intangible assets for soticlestat.”
Two other projects were removed from the pipeline, according to those disclosures: It is bowing out of an alliance with JCR to develop TAK-141, or pabinafusp alfa, a fusion protein for Hunter syndrome after a strategic assessment; it will also wind down a Phase 1 study for pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia “due to dose-limiting toxicities.”
On the other hand, Takeda put the spotlight on several promising late-stage candidates that it’s looking to steer into Phase 3, which it said will weigh R&D investments toward the second half of the fiscal year.
At the top of the list is the TYK2 inhibitor TAK-279 (zasocitinib), with a Phase 3 in psoriatic arthritis slated over the next nine months. Some time in the fiscal year 2024 or 2025, the company is also hoping to run a head-to-head against Bristol Myers Squibb’s approved TYK2 Sotyktu.
Then there’s a planned Phase 3 for TAK-079 (mezagitamab) in immune thrombocytopenia, an autoimmune disorder marked by platelet destruction and impaired platelet production. As for TAK-861, the Phase 3 in narcolepsy has already begun.
The company is counting on these drugs to expand its growth and launch portfolio, joining products like Entyvio, Eohilia, Takhzyro, Livtencity, Adzynma and Fruzaqla, which it said accounted for 46% of total revenue.