Cladribine

Europe's Committee for Medicinal Products for Human Use, which had already issued a negative opinion on Cladribine in September, confirmed that the medicine's risks outweigh its benefits.

EU Rejects Merck's Multiple-Sclerosis Pill Natascha Divac 2011

Merck is still awaiting a decision on an application to market Cladribine in the U.S, where the Food and Drug Administration recently extended a review of the drug.

EU Rejects Merck's Multiple-Sclerosis Pill Natascha Divac 2011

Merck said it remains committed to continuing and completing ongoing clinical trials on Cladribine, which has so far only been approved in Australia and Russia.

EU Rejects Merck's Multiple-Sclerosis Pill Natascha Divac 2011

"We're disappointed by the CHMP opinion, however we continue to believe that our data support Cladribine tablets as a treatment option for patients with relapsing forms of multiple sclerosis," said Bernhard Kirschbaum , Merck Serono's head of research and development.

EU Rejects Merck's Multiple-Sclerosis Pill Natascha Divac 2011

"The expectations for this appeal being successful were never high, and consensus has by now mostly removed revenues for Cladribine from Merck estimates," WestLB said in a note.

EU Rejects Merck's Multiple-Sclerosis Pill Natascha Divac 2011

FRANKFURT — Merck KGaA 's hopes of gaining European marketing approval for its multiple-sclerosis pill Cladribine were quashed Friday, after a European Union panel confirmed its negative opinion on the drug that was once set to be the first multiple-sclerosis pill worldwide.

EU Rejects Merck's Multiple-Sclerosis Pill Natascha Divac 2011

*** Pharmaceuticals Merck KGaA suffered a major blow when an advisory panel of the European Medicines Agency issued a negative opinion on multiple-sclerosis treatment Cladribine, raising doubts on whether the oral drug will ever gain approval in Europe and even in the U.S.

Business Watch 2010

Merck KGaA shed 2.8% after the German drug maker said it no longer will pursue global approval of its Cladribine tablets for the treatment of relapsing-remitting multiple sclerosis.

Europe's Markets Fall Andrea Tryphonides 2011

The same panel turned down two other pills for multiple sclerosis: Merck KGaA's Cladribine and Biogen Idec's Fampyra.

Business Watch 2011

The panel's backing gives Novartis a cutting edge over its key competitor Merck KGaA , whose multiple-sclerosis pill Cladribine Friday failed to convince the panel, effectively ending the product's chances for marketing approval in Europe.

Novartis Wins European Backing for MS Pill Goran Mijuk 2011