Merck 2010 Annual Report Download - page 55

mCRC. The share of patients in whom the test is performed in order to determine whether they
can benefit from a personalized therapy, such as Erbitux ®, increased from 2.5% in 2008 to
66% in early 2010. The results also show that 73% of physicians in Europe already routinely
tested KRAS status at diagnosis of metastatic colorectal cancer. Data from two surveys,
which were likewise presented in 2010, show that Erbitux ® has become a standard of care in
the treatment of both locally advanced and recurrent and/or metastatic SCCHN. The results
from the survey of 256 specialists in France, Germany, Italy and Spain in the latter indication
showed that an Erbitux ®-based treatment combination was used in almost 60% of cases in the
first-line setting.

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.

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.
Movectro ® approved in
Russia as the world’s first oral
disease-modifying drug for MS
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