Merck 2008 Annual Report Download - page 40

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MANAGEMENT REPORT OF THE MERCK GROUP 35
24 Responsibility
26 Merck shares
30 Pharmaceuticals business sector
50 Chemicals business sector
12 Overall economic situation
14 Economic development
of Merck
15 Financial position and results
of operations
60 Corporate and Other
61 Risk report
64 Report on expected developments
64 Subsequent events
diagnostic procedure. Accordingly, the number of second- and third-line patients ini-
tially declined as a result of the focus on patients with KRAS wild-type tumors. In the
course of expanded approval, we expect prescriptions for first-line treatment to increase,
thereby more than compensating for the lower number of patients in second- and third-
line treatment over the medium term. A crucial factor is that reimbursement in different
countries is being granted at different points in time.
Further approvals of Erbitux®
In November, Erbitux® was approved in the European Union in combination with plati-
num-based chemotherapy for treatment of head and neck tumors. This approval is based
primarily on the results of the EXTREME study, showing for the first time in 30 years a
significant survival advantage in first-line treatment setting. In addition, we received
marketing authorization in Japan for the use of Erbitux® in combination with irinotecan
in metastatic colorectal cancer – giving pretreated patients access to this new treatment.
Merck Serono, Bristol-Myers Squibb and ImClone Systems jointly market Erbitux® in
Japan. Our marketing partners receive 50% of profits.
We are working to further expand the range of approved indications for Erbitux®.
For example, we submitted an application to the European Medicines Agency (EMEA)
to approve Erbitux® for first-line treatment of epidermal growth factor receptor
(EGFR)-expressing, advanced non-small cell lung cancer (NSCLC).
Neurodegenerative Diseases
Sales by this therapeutic area were almost exclusively attributable to Rebif® (interferon
beta-1a). This product is the leading treatment for relapsing forms of multiple sclerosis
(MS) outside the United States in terms of sales. Generating sales of € 1,331 million,
or 9.3% more than in 2007, Rebif® was once again the top-selling product of the Merck
Serono division. Adjusted for currency effects, sales growth amounted to 13%, mainly
due to the weak U.S. dollar. We achieved around one-half of Rebif® sales in Europe.
The new formulation, which offers improved injection tolerability, has meanwhile been
introduced in all countries of the European Union. In 2008, the new formulation of
Rebif® was approved in many countries around the world, including Australia, Argen-
tina, Brazil and South Korea. Discussions with the U.S. Food and Drug Administration
concerning approval are ongoing. Within the EU, the key markets of Italy and Spain
showed exceptionally strong growth. More than one-third of sales were generated
in North America, where sales increased by 10% to € 530 million over the previous
year. In Latin America, sales remained at the previous year’s level overall. However,
in Brazil, a young market with considerable potential, we recorded strong double-digit
growth. The highest growth rate (+20%) was achieved in Asia, Africa, Australasia, our
smallest region.
Rebif® is the top-selling
product of the Merck Serono
division.