Germany's Merck to make new bid to enter U.S. MS pill market

Thomson Reuters

FRANKFURT (Reuters) - Germany's Merck KGaA is reviving plans to bring an oral multiple sclerosis (MS) treatment to the U.S. market, hoping for blockbuster sales, after regulators' concerns about side effects scuttled its ambitions almost seven years ago.

In early 2011, the U.S. regulator's concerns about side effects 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.

Diversified Merck, whose products include high-tech chemicals, lab equipment and cancer drugs, has now decided to also file for approval with the U.S. Food and Drug Administration during 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.

(Reporting by Ludwig Burger, editing by Emma Thomasson)

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