Neurodegenerative Diseases Audited

Within the Business Unit Neurodegenerative Diseases, we offer Rebif® (interferon beta-1a), one of the leading drugs for the treatment of relapsing-remitting multiple sclerosis (MS). According to estimates, around 2 million people suffer from MS worldwide. Owing to its proven efficacy and favorable risk-benefit profile, Rebif® is a basic treatment for MS and is approved in more than 90 countries. In 2010, sales of Rebif® increased by 8.6% to EUR 1,668 million. The recombinant protein was thus once again our top-selling product and remained the leading MS treatment outside the United States. With sales growing solidly by 6.2% to EUR 752 million, Europe was our strongest region for Rebif®. The largest markets were Germany and Italy, where we recorded growth rates of 6.0% and 8.5%, respectively. With sales of EUR 751 million, North America remained our second-largest market for Rebif®. Sales in this region grew by 11% over 2009. Sales in Latin America increased by 12% to EUR 108 million. In the region Asia, Africa, Australasia, sales increased by 2.2%.

The serum-free formulation of Rebif® with improved injection tolerability is now available in around 40 countries, including all EU member states, Australia, Canada and Switzerland, as well as a number of countries in Asia, Latin America, Africa, and the Middle East. Discussions with the U.S. Food and Drug Administration concerning a potential approval continue. Rebidose™ is the latest addition to our range of user-friendly injection devices for the self-administration of Rebif®. This single-use pen, which is prefilled with Rebif®, was approved in the European Union and Australia. Launched in 2009 as the first electronic injection device of its kind for MS, Rebismart™ is now available in more than 20 countries, including Canada and many EU countries.

Movectro® approved in Russia and Australia as an oral treatment for MS

In July, the Russian regulatory authorities granted marketing approval for cladribine tablets for the treatment of relapsing-remitting multiple sclerosis. This was the world’s first approval of an oral disease-modifying therapy for multiple sclerosis. The next approval followed in Australia in September. Cladribine tablets have been available under the trade name Movectro® in both countries since the end of 2010. The approvals are supported by the results of the CLARITY study, which involved 1,326 patients with relapsing-remitting multiple sclerosis. The study results published in the New England Journal of Medicine showed that short-course treatment with cladribine tablets significantly reduced relapse rates, the risk of disability progression, and MRI measures of disease activity at 96 weeks.

We have submitted regulatory applications for cladribine tablets covering around 40 countries worldwide. We resubmitted our regulatory application in the United States in June. The U.S. agency accepted the application for filing in July and granted a Priority Review designation. The FDA informed us in November that it had extended its Priority Review period by three months to February 28, 2011 in order to have more time for a full review of additional information provided under the application. In September, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion regarding the marketing authorization application for cladribine tablets. Since we are convinced of the potential of cladribine tablets as a new therapeutic option for people with multiple sclerosis, we appealed and requested re-examination of this opinion. In January 2011, the CHMP adopted a final negative opinion regarding our marketing authorization application.