Merck KGaA drops plans for oral MS drug cladribine, leaving field clear for Gilenya

German drug major Merck KGaA (MRK: DE) said yesterday that, following feedback from regulatory authorities, the company has decided to no longer pursue the global approval process of Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS).

Merck said the decision will result in an exceptional charge of 20 million euros ($28.8 million), after having already written off the book value of the business of about 50 million euros at the end of 2010; its shares fell 2.8% to 73 euros on the news yesterday. The firm also said it would pull the drug, trade named Movectro, from the two markets where it has managed to gain approval – Australia and Russia.

Merck had been in a race to get the first oral disease-modifying treatment for multiple sclerosis to the market with Swiss drug major Novartis’ (NOVN: VX) Gilenya (fingolimod), which gained US approval last year and was clearing by the European Medicines Agency in the spring (The Pharma Letter March 21). Its decision to drop development of cladribine in this indication now leaves Gilenya, which is already showing strong uptake, the clear leader in the oral MS sector. The Novartis drug has been forecast as having a $3.5 billion a year sales potential by 2013.