Merck KGaA / Regulatory Admission 28.07.2010 08:02 Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- 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 08:02 Ad hoc announcement, Financial News and Press Release distributed by DGAP. Medienarchiv at |[![CDATA[|[a href="http://www.dgap-medientreff.de"|]www.dgap-medientreff.de|[/a|]]]|] and |[![CDATA[|[a href="http://www.dgap.de"|]www.dgap.de|[/a|]]]|] --------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------
DGAP-Adhoc: Merck KGaA: FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of Multiple Sclerosis
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