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Takeda Halts GAMMA Study in Japan

Zacks Equity Research

Takeda Pharmaceutical Company Limited (TKPYY) and its subsidiary Millennium, recently decided to stop its ganitumab phase III (:GAMMA) global trial in Japan. Takeda’s decision was based on Amgen Inc.’s (AMGN) decision to stop the global trial with the oncology candidate.

As per the 2008 agreement with Amgen, Takeda is responsible to commercialize and develop 12 molecules from Amgen’s portfolio which included the oncology candidate ganitumab.

We note that Amgen recently suffered a pipeline setback for its oncology candidate, ganitumab. The randomized, multicenter, double-blind, GAMMA study evaluated whether the combination of ganitumab and Eli Lilly’s (LLY) Gemzar improved overall survival in patients suffering from metastatic adenocarcinoma of the pancreas versus placebo and Gemzar, as a first-line therapy.

However, after conducting a pre-planned interim analysis of the data, an independent Data Monitoring Committee (:DMC) concluded that the combination of AMG479 and Gemzar would not be likely to improve survival in patients compared to Gemzar plus placebo. However, the DMC’s analysis of the data from the phase III study did not raise any safety concern(s).

Takeda and Millennium will discuss the future of the candidate in Japan.

Our Take

Takeda is one of the largest pharmaceutical companies in Japan and one of the worldwide leaders in the industry. We believe the halting of the ganitumab study will not be a major concern for Takeda. We expect investor focus to stay on the company’s marketed products and the success of other late-stage candidates.

Takeda carries a Zacks #3 Rank (Hold rating) in the short run.

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