Merck 2010 Annual Report Download - page 56

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.
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The Merck Serono division is the global leader with its portfolio of drugs to treat infertility.
We are the only company that offers physicians and patients recombinant versions of the three
main reproductive hormones that are important for the treatment of infertility. In 2010, sales
by the Business Unit Fertility increased by 6.6% to EUR 657 million. We generated nearly half
of our sales in Europe, which remains our largest market. In 2010, sales in Europe were slightly
higher than in 2009. We recorded double-digit growth in the regions Asia, Africa, Australasia
and Latin America, while sales increased slightly in North America.
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Gonal-f ® (follitropin alfa for injection) is a recombinant form of the natural follicle-stimulating
hormone. It is approved in over 100 countries and is the world’s leading female fertility drug.
The injection device Gonal-f ® pen for the self-administration of Gonal-f ® is now available in
more than 90 countries, including the largest EU markets, the United States and Japan. Sales
of Gonal-f ® grew by 3.7% to EUR 504 million, primarily as a result of strong growth of 15%
in Asia, Africa, Australasia. Positive currency effects were responsible for more than half of the
increase in this region. Gonal-f ® was additionally approved in Japan in 2009 for the treatment
of infertile women with irregular or absent ovulation. Consequently, sales increased sharply in
2010. In North America, Gonal-f ® sales remained at the previous year’s level in a declining and
hotly contested market. In Europe, which accounts for nearly half of our Gonal-f ® sales, we
stopped the negative trend of 2009 and maintained sales at the previous year’s level despite
unabated cost containment pressure in the health care sector. In Italy, our largest European
market for this product, sales remained just as stable as in France, our second-largest market.
Spain is the third-largest market in Europe and is dominated by private payers, who continued
to feel the effects of the economic crisis. Consequently, sales of Gonal-f ® declined by 4.3%. By
contrast, Gonal-f ® performed well in the United Kingdom. Sales grew strongly in this market,
mainly on an organic basis, increasing 31% over 2009.
Double-digit increase in sales
in important growth markets
Merck Annual Report 2010 52