Merck KGaA: Merck KGaA Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application

Merck KGaA / Regulatory Admission

30.11.2009 

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Darmstadt, November 30, 2009 - Merck KGaA announced today that its US
affiliate received on November 25 2009 (US-time) a refuse to file letter
from the US Food and Drug Administration (FDA) on the New Drug Application
(NDA) for Cladribine Tablets, Merck Serono's proprietary investigational
oral formulation of cladribine, as a therapy for relapsing forms of
multiple sclerosis (MS). The company will work closely with the FDA to
fully understand FDA's concerns and define a path forward for a successful
resubmission of this application at the earliest point in time.

Based on current regulations, once a NDA is submitted to the FDA, the
Agency has 60 days to preliminarily review the NDA submission and assess
whether the NDA is sufficiently complete to permit a substantive review. If
it determines that the NDA is not sufficiently complete, the FDA issues a
refuse to file letter to the applicant.


Steffen Mueller
+49 6151 72-2386




30.11.2009  Financial News 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 62 95
Fax:          +49 (0)6151 72 31 64
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, München, Hannover, Düsseldorf, Hamburg, Stuttgart;
              Terminbörse EUREX; Foreign Exchange(s) London, SWX
 
End of News                                     DGAP News-Service
 
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