Merck KGaA: Negative CHMP Opinion for Cladribine Tablets in Multiple Sclerosis

Merck KGaA  / Key word(s): Regulatory Admission

24.09.2010 07:30

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Darmstadt, Germany, September 24, 2010 - Merck KGaA announced today that
the Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has issued a negative opinion regarding the
marketing authorization application (MAA) for Cladribine Tablets as a
treatment for relapsing-remitting multiple sclerosis (MS). The CHMP is of
the opinion that based on currently available data the benefits of
Cladribine Tablets do not outweigh its risks. Merck is committed to making
Cladribine Tablets available to MS patients in Europe and is evaluating all
options to gain approval in the European Union, including a potential
appeal to request re-examination of the submission by the CHMP, in
accordance with the current European regulatory legislation.

Phyllis Carter
Tel: +49 6151 72-7144




24.09.2010 DGAP's Distribution Services include Regulatory Announcements, 
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Language:     English
Company:      Merck KGaA
              Frankfurter Str. 250
              64293 Darmstadt
              Deutschland
Phone:        +49 (0)6151 72 - 3321
Fax:          +49 (0)6151 72 - 913321
E-mail:       investor.relations@merck.de
Internet:     www.merck.de
ISIN:         DE0006599905
WKN:          659990
Indices:      DAX
Listed:       Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
              in Berlin, Hannover, Stuttgart, Hamburg, München, Düsseldorf;
              Terminbörse EUREX; Foreign Exchange(s) London, SIX
 
End of Announcement                             DGAP News-Service
 
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