Merck KGaA noted on Thursday in its Q4 2023 results that the company has canceled the BTK inhibitor evobrutinib for the treatment of multiple sclerosis. CEO Belén Garijo stated during the investor call that the program has been officially terminated.In December 2023, the company announced that its two Phase III trials evaluating the safety and efficacy of evobrutinib did not meet the primary endpoint of reducing the annual relapse rate in patients with multiple sclerosis (MS).However, terminating the contract does not seem to have stopped Dr. Garijo from participating in teleconferences. She noted that despite setbacks with evobrutinib, the company remains "quite solid and well-positioned in the healthcare sector."Gariglio mentioned that the termination cost is 95 million euros ($103.8 million). However, this is a one-time payment. She also stated that evobrutinib will not incur pre-launch costs as it did last year.Merck KGaA Hit Obstacles with Its BTK Inhibitor. In April 2023, the FDA placed a hold on the Phase III trial after two multiple sclerosis patients showed signs of liver injury. At the time, the company was not allowed to enroll new participants in the trial, and dosing was halted for participants who had been on the drug for less than 70 days.BTK inhibitors, as a class of drugs, have also encountered obstacles.Just before Merck's Phase III trial failure, Roche's BTK inhibitor for the treatment of multiple sclerosis was put on clinical hold by the FDA due to some potential cases of liver injury. Specifically, two patients participating in Roche's Phase III study experienced abnormally elevated liver transaminase levels after receiving the dose.The FDA has placed partial clinical holds on other BTK inhibitors.Meanwhile, Merck has been exploring other areas. In January 2023, the company expanded its colorectal cancer portfolio by securing licenses for two assets from Inspirna with an upfront payment of $45 million. On Monday, the German company also made a $16 million upfront payment to C4 Therapeutics, which could potentially receive over $740 million in milestone payments, to establish a research collaboration aimed at discovering two targeted protein degraders against "key oncogenic proteins."Now, evobrutinib has also disappeared from the pipeline.Moreover, after many days of non-tracking, the former MUCI/EGFR bispecific ADC drug M1231 has also disappeared from the pipelines of both companies.
In September 2023, this product was still available.
In 2021, I wrote about this variety. You may want to take a look.At that time, EGFR/bispecific antibody, including Met, was proposed.
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