FDA rejects Merck KGaA's cladribine app

The FDA has handed back Merck KGaA's application for the oral MS drug cladribine, slapping the German pharma company with a "refuse to file" notice and dealing it a setback in its race with Novartis, which is preparing to file for approval of FTY720. Analysts had a field day with the news, wondering how long it will take Merck KGaA to get its application in order and helping drive down its share price.

"It is the worst of all possibilities," Sal. Oppenheim analyst Peter Duellmann told the Wall Street Journal. "Until now, the question was whether the drug will get a priority review or not. Now the FDA won't even look at it." And Commerzbank AG cut the company's rating from add to hold. "This will certainly delay market entry and the amount of time will depend on the full nature of the required actions, which is not yet known to us," DZ Bank analysts Elmar Kraus and Thomas Maul said in a note to clients.

"The company will work closely with the FDA to fully understand the FDA's concerns and define a path forward for a successful resubmission of this application at the earliest point in time," Merck KGaA said in a statement.

- check out the Wall Street Journal report
- here's the Reuters story
- here's an item from Bloomberg