Merck has developed oral therapy for relapsing forms of multiple sclerosis (MS). Cladribine is earlier known for treatment of cancer (leukemia) in intravenous administration. Now Merck licensing from Ivax (Teva subsidiary) has developed oral therapy for MS.
This product is now at pre-registration stage in USA and approved in Russia and Australia. Europe’s CHMP has given negative opinion for Cladribine oral therapy (Press release).
Patent: Ivax has two patent application on oral formulation of Cladribine, which are WO2004087101 & WO2004087100. Probably these patent applications may cover marketed formulation of Cladribine.