Commercial Kyowa Kirin considering asset sales of $1B as focus...

Kyowa Kirin considering asset sales of $1B as focus shifts to PI3K inhibitor advancement

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Japanese pharmaceutical company Kyowa Kirin is looking to sell assets worth $1B. According to reports, Kyowa Kirin could possibly be selling off some of its assets in the international market.

The owner of Kyowa Kirin is Kirin Holdings, a very large business that ranges from beverage to pharmaceutical industries. Kirin Holdings own a majority share of Kyowa Kirin, which is 54%.

According to Bloomberg, numerous buyers are already set for the sale of the company’s mature assets. The assets to be sold have not been disclosed yet. Kyowa Kirin has refused to comment on the rumors and Bloomberg reported that any discussions that may be taking place are in the initial stages and may or may not amount to anything.

Although the question of the sale of assets remains unanswered, Kyowa Kirin and MEI Pharma, its developmental partner based out of San Diego, California, are dedicated to the progression of their PI3K (phosphatidylinositol-3-kinase) inhibitor called zandelisib. The partnered companies revealed early in the year that they required more clinical data before the U.S FDA (Food and Drug Administration) would review their inhibitor zandelisib for regulatory approval.

Last week Friday, the MEI and Kyowa Kirin showed updated data from the clinical development of the inhibitor. This included the single-arm Phase II TIDAL study that evaluated zandelisib for the treatment of follicular lymphoma at the European Hematology Association 2022 Hybrid Congress. The resulting data showed 70.3% response rate for zandelisib as a monotherapy, and a complete response rate of 35.2%. The primary endpoint of the TIDAL study was ORR.

Both the companies let it be known that the duration of response was not yet reached in the study. Another data disclosure is scheduled for a year and two months after the enrollment of the last patient.

However, FDA has suggested a randomized trial to sufficiently assess drug safety and efficacy of PI3L inhibitor drug candidates. The concern is partly due to safety reasons. The companies also mentioned that nearly 10% of the patients in the TIDAL study discontinued treatment with zandelisib on account of unfavorable events.

Zandelisib data has come at a bad time when regulatory agencies are increasingly scrutinizing PI3K inhibitors. In early June, FDA pulled the approval for TG Therapeutics’ drug for cancer called Ukoniq (umbralisib) owing to safety concerns. Before this approval withdrawal, TG Therapeutics had willingly withdrawn Ukoniq from the market.

There are other PI3K Inhibitors that have seen safety concern issues. Zydelig (idelalisib), the PI3K inhibitor by Gilead Sciences was also withdrawn from the market as PI3K inhibitors generally become a difficult class of drugs for the regulatory authority of the Food and Drug Administration (FDA).

An FDA advisory committee suggested the stopping of the single-arm clinical trials of PI3K inhibitors owing to safety concerns. However, Oncologic Drug Advisory Committee of the FDA suggested using randomized clinical trials to alleviate the safety risks.

Kyowa Kirin and MEI’s efforts at winning the approval for zandelisib were delayed due to this very concern of the FDA.

Elsewhere, AstraZeneca has also been indulging in asset sales in the last few years, while recently, Sanofi sold rights to Libtayo, a cancer drug, to Regeneron for $900M.

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