Merck KGaA halts approval process for MS drug cladribine

Merck KGaA said Wednesday that following feedback from regulators it "has decided to no longer pursue the global approval process of cladribine" for the treatment of relapsing-remitting multiple sclerosis. The drugmaker added that it will also withdraw the oral drug from markets in Australia and Russia where it was previously approved under the name Movectro.

In March, the FDA issued a complete response letter regarding Merck’s filing for cladribine, asking that the company either provide additional analyses of study results, or conduct new trials. Merck noted that based on talks with the agency, "data from ongoing clinical trials are very unlikely to address the FDA requirements and will not provide a basis for approval." Merck indicated that the feedback from the regulator was similar to that received from the European Medicines Agency, which had determined that the available data did not allow it to issue a positive recommendation on the therapy.

"Considering the time it would take to complete a new clinical trial programme and the significant risk that even a new programme would not result in data sufficient for…approval…we have decided to not pursue further the worldwide approval process of cladribine,"stated Stefan Oschmann, president of Merck Serono. Oschmann said the drugmaker would instead "focus resources on other projects bringing benefit to patients with multiple sclerosis."

Merck indicated that the withdrawal would result in a one-off charge of 20 million euros ($29 million) in the second quarter, after it had already written off the book value of the business of about 50 million euros ($72 million) at the end of last year.

Commenting on the news, Silvia Quandt Research analyst Stefan Muehlbauer remarked that "it was widely expected that the company would no longer seek global approval for cladribine following the negative FDA decision last fall." Jack Scannell, an analyst with Sanford C. Bernstein & Co., said that "at best we thought this drug could be salvaged in 2013 and 2014 and by then the impact on revenue would be minimal." The compound had been predicted by analysts to generate annual sales in excess of 1 billion euros ($1.4 billion), if approved.

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