FRANKFURT (Reuters) – Germany’s Merck KGaA (MRCG.DE) is reviving plans to bring an oral multiple sclerosis (MS) treatment to the U.S. market, hoping for blockbuster sales despite regulatory concerns about side effects having frustrated its ambitions almost seven years ago.
In early 2011 the U.S. regulator’s concerns put an end to Merck’s development plans for the cladribine pill, now branded as Mavenclad, but Merck later revived efforts by focusing on the most severely affected patients and won approval in Europe in August this year.
Merck, whose products include high-tech chemicals, laboratory equipment and cancer drugs, has now decided also to file for approval with the U.S. Food and Drug Administration (FDA) in the second quarter of 2018, the head of its healthcare division, Belen Garijo, told Reuters.
“If Mavenclad is approved in the U.S., we see this opportunity as one of the significant growth drivers in our MS franchise and we would say that Mavenclad will in the longer term develop blockbuster potential,” she said.
The industry term blockbuster typically implies annual sales of at least $1 billion, but Garijo would not elaborate on figures.
“Our aspiration is to be able to serve the same patient group that is now benefiting under the European registration. But of course the label will have to be approved by the FDA,” the Merck executive said.
Biogen (BIIB.O), Novartis (NOVN.S) and Sanofi (SASY.PA) have long pulled ahead with novel MS treatments taken as a pill, gradually replacing standard injection therapies and reaching a combined share of the overall MS market of more than 40 percent.
If approved in the United States Mavenclad will also be up against Roche’s (ROG.S) Ocrevus, an infusion drug that has had U.S. approval since March and which analysts expect to generate $1.5 billion in sales next year.
But Garijo said Ocrevus was targeted mainly at primary progressive MS, which Mavenclad was not developed for treating.
“Mavenclad seems to be a pretty effective MS drug and is tolerated relatively well, but there is a fair amount of baggage associated with the product and in a very competitive market,” Bernstein’s Kapadia said.
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