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Merck Serono pulls MS drug

Merck Serono has said it is to no longer pursue global approval for the use of cladribine in the treatment of multiple sclerosis

Merck Serono has said it is to no longer pursue global approval for the use of cladribine in the treatment of multiple sclerosis (MS).

The decision follows feedback from regulatory bodies including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), according to Merck Serono.

The FDA denied approval for the drug in March 2011, while the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion regarding the marketing authorisation application for cladribine.

Merck Serono said it believes that data from ongoing clinical trials are 'very unlikely' to address requirements set by the FDA and will not provide a basis for approval.

In order to fulfil such requirements, the company would have to set up a new clinical trial programme, which would take several years to complete.

Dr Stefan Oschmann, president of Merck Serono, commented: "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 cladribine tablets' approval, and taking into account the changing competitive landscape, we have decided to not pursue further the worldwide approval process of cladribine tablets and to focus resources on other projects bringing benefit to patients with multiple sclerosis."

Merck Serono says it intends to withdraw the product from Australia and Russia where the drug is approved and marketed as Movectro. The company said it will discuss the process with local regulatory agencies to decide the best course of action for patients currently using the treatment.

A one-time charge of €20m will be recorded in Merck Serono's second quarter financial results.

22nd June 2011

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