German Merck KGaA said they believe the European Medicines Agency (EMEA) will approve oral pill Cladibrine, to treat multiple sclerosis by 3Q 2010.

The head of Merck's drug unit Elmar Schnee anticipated at an investors meeting, that there were high chances that the drug will be cleared by 3Q of 2010. EMEA documentation was originally filed during July 2009. Previous tentative approval date was last Q2010.

However, Cladibrine approval in the United States is still a doubt. The FDA rejected documentation filed by Merck last December, as it was considered “incomplete”. FDA rejection gave the opportunity for the competitor´s drug, Novartis AG oral pill Gilena (Fingolimod or FTY 720) that has already been granted priority status review , last February 22nd.

According to market analysts, Cladibrine has an interesting future with estimated annual sales of 950 to 1000 million dollars.