Merck KGaA: FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of Multiple Sclerosis

Merck KGaA / Regulatory Admission

28.07.2010 08:00

Dissemination of an Ad hoc announcement according to § 15 WpHG,
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The issuer is solely responsible for the content of this announcement.

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Darmstadt, Germany, July 28, 2010 - Merck KGaA announced today that the
U.S. Food and Drug Administration (FDA) has accepted for filing the New
Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing
forms of multiple sclerosis (MS).

The application also has been granted a Priority Review designation by the
FDA, which means the review period for the NDA is reduced. The goal for
completing a Priority Review is six months instead of the standard ten
months. Priority Review is applied to drugs that have the potential to
provide significant advances in treatment. A decision by the FDA is
expected in Q4 2010.


Phyllis Carter
Phone +49 6151 72-7144




28.07.2010 Ad hoc announcement, Financial News and Press Release
distributed by DGAP.
Media archive at www.dgap-medientreff.de and www.dgap.de

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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, Düsseldorf, München, Hannover, Stuttgart, Hamburg;
              Terminbörse EUREX; Foreign Exchange(s) London, SIX
 
End of News                                     DGAP News-Service
 
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