In Neurodegenerative Diseases, our focus is on new therapeutic options for patients with multiple sclerosis. In November, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) issued a positive opinion on our application to extend the indication for our MS drug Rebif®. EU marketing authorization was granted in January 2012. The indication extension relates to the use of Rebif® in patients who have experienced a single demyelinating event, an early sign of the disease, and who are at high risk of converting to MS. The marketing authorization application submitted in June was based on the results of the two-year REFLEX study with over 500 patients. Rebif® significantly delayed the onset of MS in these patients. A three-year double-blind extension of the REFLEX study, called REFLEXION, is currently ongoing in order to provide long-term follow-up data. We also submitted marketing authorization applications for the new indication in Canada and Switzerland.
We further expanded our portfolio of compounds for the treatment of MS, acquiring from Peptimmune the global exclusive rights to plovamer (PI-2301), a second-generation peptide copolymer thought to enhance the regulatory response of the immune system, which has successfully completed Phase Ib trials in MS. In addition, we were granted a license by Ono Pharmaceutical to develop and commercialize ONO-4641, an oral investigational sphingosine-1-phosphate (S1P) receptor modulator, in Phase II in MS, worldwide except in Japan, Korea and Taiwan.
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