Kyowa Kirin Pharmaceutical Development Ltd.

Japan’s Kyowa Kirin Pharmaceuticals could be eying the potential sale of $1 billion worth of assets. According to reports citing “people familiar with the matter,” Kyowa Kirin, a specialty pharma company, could be lining up the sale of some assets sold on the international market. Bloomberg reported that several buyers are already lined up for the sale of some of the company’s more mature assets. The assets in question have not been specifically identified. The Bloomberg report noted that deliberations into any sale are in the preliminary stages and may not go anywhere. Kiowa Kirin declined to comment on the speculation. While the sale of assets remains in question, Kyowa Kirin and its developmental partner MEI Pharma of San Diego are focused on the advancement of their phosphatidylinositol-3-kinase (PI3K) inhibitor zandelisib. Earlier this year, the two companies announced that additional clinical data was required before the U.S. Food and Drug Administration would review zandelisib for regulatory approval. On Friday, the two companies presented updated data from the clinical development of zandelisib, including the single-arm Phase II TIDAL study assessing zandelisib as a treatment for follicular lymphoma at the European Hematology Association 2022 Hybrid Congress. Data showed that the ongoing response rate for zandelisib as a monotherapy was 70.3%, with a 35.2% complete response rate. ORR was the primary endpoint of the TIDAL study. The companies noted that the duration of response has yet to be reached in the study. An additional data readout is scheduled for approximately 14 months after the last patient is enrolled. Despite that data, the FDA has recommended a randomized trial to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates. Part of that concern is due to safety reasons. Kyowa Kirin and MEI noted that almost 10% of patients in the TIDAL study have discontinued treatment with zandelisib due to adverse events. The data for zandelisib comes at a time when PI3K inhibitors are facing increased scrutiny by regulatory agencies. Earlier this month, the FDA pulled approval for TG Therapeutics’ cancer drug Ukoniq (umbralisib) due to ongoing safety concerns. Prior to that withdrawal of approval, TG Therapeutics had already voluntarily withdrawn Ukoniq from the market for the approved uses in the two types of lymphoma. Ukoniq isn’t the only P13K inhibitor that has seen its share of safety concerns. Gilead Sciences has withdrawn its P13K inhibitor Zydelig (idelalisib) from the market, and PI3K inhibitors, in general, have become an especially troubling class of drugs for the FDA. Earlier this year, an FDA advisory committee overwhelmingly recommended halting single-arm clinical studies of PI3K inhibitors due to safety concerns. Instead, the FDA’s Oncologic Drug Advisory Committee recommended the use of randomized clinical trials in order to mitigate the safety concerns. It’s this concern that caused the FDA to delay MEI and Kyowa Kirin’s attempts at winning regulatory approval for zandelisib.

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