Merck KGaA suffers major blow as MS drug fails in late-stage trials

FRANKFURT, Dec 5 (Reuters) – Germany’s Merck KGaA (MRCG.DE) said its experimental multiple sclerosis drug evobrutinib did not meet the primary goal in highly anticipated late-stage trials, dealing a major blow to the company’s growth ambitions.

In the Phase III trials, evobrutinib failed to reduce the annualized relapse rate compared to Sanofi’s (SASY.PA) Aubagio in patients with relapsing multiple sclerosis, Merck said in a statement on 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 MS drugs in a class known as Bruton’s tyrosine kinase (BTK) inhibitors.

Investors have been kept on edge over revenue prospects because of a possible link to liver damage from the drug category, which is designed to more selectively block the cells that drive the harmful autoimmune reaction behind MS.

After weak demand hit Merck’s specialty materials businesses, analysts have said a successful launch of evobrutinib was key to the diversified group reaching its goal of generating 25 billion euros ($27 billion) in sales by 2025, up from 22.2 billion in 2022.

CEO Belen Garijo said as recently as October that the multiple sclerosis drug can have “blockbuster” status, an industry term for annual sales that exceed $1 billion, even after concerns emerged that it may cause liver damage.

Merck said in April that U.S. regulators had paused enrolment of new patients into a trial testing evobrutinib, knocking the German drugmaker’s share price.

At the time, the company said the Food and Drug Administration had cited lab results suggesting drug-induced liver injury, but the affected patients had no symptoms and did not require medical intervention.

Sanofi had run into similar problems with its BTK drug candidate tolebrutinib.

Novartis said in April that no signs of liver damage had been seen in trials testing its anti-inflammatory drug candidate remibrutinib so far.

Roche said in May that its BTK inhibitor against MS, fenebrutinib, reduced harmful brain lesions associated with the disease in a midstage trial and that no new safety concerns had emerged.

($1 = 0.9263 euros)

Our Standards: The Thomson Reuters Trust Principles.