EU regulators rebuff Merck KGaA on MS drug

Merck KGaA got bad news today with EU regulators issuing a negative opinion regarding the marketing authorization application for cladribine tablets as a treatment for relapsing-remitting multiple sclerosis. The decision caused the company's shares to dip 8 percent, according to MarketWatch.

The European Medicines Agency's Committee for Medicinal Products for Human Use based its opinion on currently available data that the benefits of the tablets do not outweigh its risks. In a statement, the company emphasizes that it is committed to making cladribine tablets available to MS patients in Europe and is evaluating all options to gain approval, including a potential appeal to request re-examination of the submission by the CHMP.

"We are disappointed by the CHMP opinion but remain fully committed to the potential of Cladribine Tablets to meet an unmet medical need as an oral short-course, disease-modifying drug for multiple sclerosis," says Elmar Schnee, member of the executive board and head of the Merck Serono division. "With the considerable support of the multiple sclerosis community and backed by the recent approvals in Australia and Russia, we will continue to work with the CHMP to address the committee's concerns and pursue a way forward to make Cladribine Tablets available to patients from the European Union."

Societe Generale analyst Marietta Miemietz said the committee's decision now makes EU approval unlikely. But the direct impact of lost sales is likely to be limited--SocGen was forecasting EU sales of cladribine of 200 million euros ($267 million) in 2015, MarketWatch notes.

Earlier this week, Novartis won FDA approval for its Gilenya tablet--giving the drugmaker an edge against Merck in the U.S. Late last year, the FDA handed back Merck's application for cladribine, slapping the German pharma company with a "refuse to file" notice. And the EU's decision may make investors concerned about the pill's chances of approval in the U.S., Leslie Iltgen, a Frankfurt-based analyst at Bankhaus Lampe KG, tells Bloomberg.

- see Merck's statement
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