Takeda Loses Bid to Nix $155 Million Bayer Win in Drug Case

Takeda Loses Bid to Nix $155 Million Bayer Win in Drug Case

(Bloomberg) -- Takeda Pharmaceutical Co.‘s Baxalta unit lost its bid to overturn a $155 million jury verdict won by Bayer AG for royalties from sales of a hemophilia drug.

U.S. District Judge Richard Andrews also denied Takeda’s request for a new trial, according to his opinion, filed Friday in Wilmington, Delaware. A jury in February found Baxalta’s drug, Adynovate, infringes a Bayer patent.

Adynovate is used to control bleeding in patients with hemophilia A, caused by a deficiency of the Factor VIII protein, which is needed to control bleeding. Bayer’s technology makes the injectable protein last longer in the body, reducing the frequency of injections for patients.

“We are pleased with the court’s decision, which confirms the strength of Bayer’s innovation in hemophilia treatment,” said Christopher Loder, a spokesman for Bayer.

Representatives of Takeda didn’t immediately respond to a request for comment.

Takeda reported Adynovate sales of 10.7 billion Japanese yen ($101.6 million) during the 12 months ended March 31, according to data compiled by Bloomberg. Takeda bought Shire Plc, the parent of Baxalta, for $62 billion in a deal that closed Jan. 9.

Takeda’s Shire business may erode 26% by 2022, Elizabeth Krutoholow, a Bloomberg Intelligence analyst, said in a May 24 report, but “it will still maintain almost a third of the market, our analysis shows, since products such as Adynovate have long-term safety data.”

Meanwhile, Bayer is facing challenges to its treatment for hemophilia A.

In a September 2017 lawsuit, Shire claimed Bayer’s planned injectable for hemophilia A, then called BAY 94, infringed patents for on-demand treatment of bleeding episodes. That Delaware case is pending. Shire again sued Bayer in August 2018, accusing Bayer’s Jivi, as BAY 94 was renamed, of infringing five patents for Adynovate. That case, filed in Delaware one day after the U.S. Food and Drug Administration approved Jivi, was consolidated with the 2017 lawsuit; a seven-day jury trial on liability is set for April 2020, with another trial on damages to follow, if needed.

The case is Bayer Healthcare LLC v. Baxalta Inc., 16-cv-1122, U.S. District Court, District of Delaware (Wilmington).

©2019 Bloomberg L.P.

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