New Products

After a long, painful revamp, Merck KGaA scores key OK for once-defunct MS drug cladribine

Merck KGaA’s failure with its MS drug cladribine six years ago triggered a long and painful revamp in its R&D group, earning the German pharma company a rep for failure that stained everything they did. Its comeback today with a European approval may also serve as notice that the turnaround that was long promised has actually begun.

Belén Garijo

Merck KGaA never quite fully let go of the cladribine program, after its researchers managed to come up with one of the worst late-stage development plans in the field. Its single Phase III raised safety questions on cancer that took years to address. But researchers finally came up with new data and results that won over regulators at the EMA, who were quick to turn thumbs down on the first attempt.

Today Merck KGaA says that it will sell the drug as Mavenclad as the “first oral short-course treatment to provide efficacy across key measures of disease activity in patients with highly active (relapsing) MS.”

And now that it finally has been able to chalk this one up as a win, after watching rivals at Biogen and Sanofi/Genzyme rack up billions in sales, the German Merck plans to hunt down an OK at the FDA and in other countries around the world.

This has been a big year for Merck KGaA, which partnered with Pfizer on avelumab and pushed the checkpoint inhibitor to key approvals. Cladribine factored in as a key exhibit in their case that the company’s R&D group had finally turned the corner after one of the longest dry spells of any major biopharma company. Last fall the company promised investors that it was just beginning a string of new drug or indication approvals. By 2022, they promised, they’ll be able to count $2.2 billion in added revenue from new drugs.

The revenue has yet to be seen, but the approvals are starting.

“With the approval of Mavenclad in the European Union, we are pleased to offer patients and clinicians an innovative agent with a simplified dosing schedule as a new approach to managing active relapsing MS,” said Belén Garijo, Merck KGaA’s CEO of healthcare.



The best place to read Endpoints News? In your inbox.

Full-text daily reports for those who discover, develop, and market drugs. Join 21,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Biomanufacturing