(Rewrites on all levels) by Ludwig Burger
Germany’s Merck KGaA MRCG.DE said its experimental multiple sclerosis drug evobrutinib failed to meet the primary goal in highly anticipated late-stage trials, dealing a major blow to growth ambitions of the society.
In phase III trials, evobrutinib failed to reduce the annualized relapse rate compared with Sanofi’s Aubagio SASY.PA in patients with relapsing multiple sclerosis, Merck said in a statement Tuesday .
Merck was seen as ahead of Sanofi SASY.PA , Novartis NOVN.S and Roche ROG.S in a four-way race to develop more targeted multiple sclerosis drugs in a class known as tyrosine inhibitors Bruton kinase (BTK).
Investors have remained wary of earnings prospects because of a possible link to liver damage caused by this class of drugs, designed to more selectively block the cells that cause the harmful autoimmune response in sclerosis in plates.
After weak demand hit Merck’s specialty materials business, analysts said a successful launch of evobrutinib was critical for the diversified group to meet its goal of generating 25 billion euros ($27 billion). dollars) in sales by 2025, compared to 22.2 billion in 2022.
Chief Executive Belen Garijo said as recently as October that the multiple sclerosis drug could have “blockbuster” status, an industry term for annual sales that exceed $1 billion, even after that concerns have arisen that it may cause liver damage.
Merck said in April that U.S. regulators halted the recruitment of new patients in a trial testing evobrutinib, sending the German drugmaker’s stock price tumbling.
At the time, the company said the Food and Drug Administration cited laboratory results suggesting drug-induced liver injury, but that the affected patients had no symptoms and did not require medical intervention.
Sanofi encountered similar problems with its BTK drug candidate tolebrutinib.
Novartis said in April that no signs of liver damage had been observed in trials of its anti-inflammatory drug candidate remibrutinib so far.
Roche said in May that its multiple sclerosis BTK inhibitor, fenebrutinib, reduced harmful brain damage associated with the disease in a mid-stage trial and that no new safety concerns had emerged.
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