With Rebif® (interferon beta-1a), we offer a leading drug for the treatment of relapsing multiple sclerosis (MS). Rebif® is registered in more than 90 countries. According to estimates, around 2 million people suffer from MS worldwide. In spite of the availability of a new oral drug on the market, the sales development of Rebif® remained satisfactory, increasing slightly by 1.4% to € 1,691 million in 2011. With sales of € 773 million, North America was, for the first time, our largest market for Rebif®. Sales grew by 2.9% over 2010. In Europe, sales of Rebif® were slightly below the previous year’s level and totaled € 742 million (–1.4%). The highest sales were achieved in Germany and Italy, where we recorded growth rates of 6.8% and 2.7%, respectively. In Latin America, sales increased by 3.2% to € 111 million; in Asia, Africa, Australasia, growth amounted to 14%. The human serum albumin-free formulation of Rebif® is now available in 40 countries around the world. We launched this product, which has improved injection tolerability, in 2007. After having evaluated feedback from the U.S. Food and Drug Administration (FDA), we decided not to pursue registration in the United States any longer.
As of the end of 2011, roughly 30,000 patients outside of the United States were using Rebismart™, the only electronic injection device in MS. Launched in 2009, Rebismart™ allows Rebif® patients to customize their injection settings, and an electronic injection history also enables active adherence management.
Merck Serono is actively supporting the MS community. For example, with the digital platform “UniteMS.net”, we created an international social MS network. We also set up the Web portal “MS World Council” especially for health care professionals in 2011. We are also involved in several collaborations designed to advance research into MS, such as our collaboration with Fast Forward, a not-for-profit organization established by the American National Multiple Sclerosis Society.
Based on feedback from the regulatory authorities in the EU and the United States, we decided in June to not pursue further the worldwide approval process for cladribine tablets. Attempting to fulfill the requirements of the European Medicines Agency and the FDA would have necessitated a new, multi-year clinical trial program. In Australia and Russia, where cladribine tablets were registered under the brand name Movectro®, we discontinued market supply of the product in close coordination with the authorities.
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