Merck KGaA (MRK), which lost the race against Novartis AG to introduce the first multiple sclerosis pill, will no longer seek approval for the experimental Cladribine medicine after regulators said the German drugmaker would have to start a new clinical trial program.
The decision will result in an exceptional charge of 20 million euros ($28.8 million) in the second quarter, the Darmstadt, Germany-based company said in an e-mailed statement today.
“Attempting to fulfill the FDA and the EMA requirements would necessitate the initiation of a new clinical trial program which would take several years to complete,” Merck said in the statement. Cladribine’s benefit-risk profile hasn’t changed, it said.
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