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Corporate Communication
Soo-Kyung Jeon (2185-3919 / 010-4746-3919)
Kyung-Jin Hahn (2185-3838 / 010-8763-3838)
May 27, 2010
Merck Serono Presents Further Evidence of Sustained Innovation in
Oncology at ASCO 2010

Merck Serono at the forefront of innovation using biomarkers, such as KRAS, to
advance disease management and improve patient outcomes

Merck Serono continues to invest in pioneering research for cancers including
colorectal cancer, head and neck cancer and glioblastoma
Darmstadt, Germany, May 20, 2010 – In alignment with the theme “Advancing quality through
innovation” of the forthcoming annual meeting of the American Society of Clinical Oncology
(ASCO, June 4-8 in Chicago), Merck Serono, a division of Merck KGaA, Darmstadt,
Germany, will present new data from across its oncology franchise. Data included at the
meeting will highlight the impact of KRAS testing and personalized therapy, an area of
innovation which the company has championed. Further, additional data for Erbitux®
(cetuximab) underscore the positive impact the treatment has had in metastatic colorectal
cancer (mCRC) and head and neck cancer. New data for cilengitide, the first integrin inhibitor
to reach Phase III development in oncology, and the MEK* inhibitor AS703026 will also be
presented.
“Merck Serono's contribution to innovation in cancer care has enabled identification of
biomarkers and treatments that have made, and will continue to make, a difference to
patients,” said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. “We
believe we have helped spearhead a movement within the oncology community to drive
innovations that may change cancer management.”
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Merck Ltd. Korea
Merck Advanced Technologies Ltd.
Haesung-2-Bldg. 15th Floor
942-10, Daechi-2-dong, Gangnam-gu
Seoul 135-725, Korea
Phone +82 (02) 2185-3800
Fax +82 (02) 2185-3900
http://www.merck.co.kr
News Release
Erbitux® – driving changes in cancer care through quality and innovation
One of the most exciting recent innovations in cancer management has been the discovery of
predictive biomarkers of treatment efficacy that now allow patients to receive personalized
therapies that offer them the best possible treatment outcomes. Merck Serono has led the
way in the development of personalized therapies, such as Erbitux®, the epidermal growth
factor receptor (EGFR) inhibitor. Erbitux® is the first and only targeted therapy for mCRC to
have provided, in combination with the standard FOLFIRI chemotherapy regimen, a
significant increase in overall survival in KRAS wild-type patients compared to chemotherapy
alone.1
New data to be published at ASCO 2010 will reveal the global impact of KRAS testing and
personalized therapy for the clinical management of mCRC.2 Furthermore, additional data
for Erbitux® will add to the growing pool of clinical evidence for the drug, underlining its role,
in tandem with KRAS testing, in the optimal management of mCRC. 3
Erbitux® is also an innovation in the treatment of head and neck cancer as the first treatment
in 30 years to improve overall survival when combined with standard platinum-based
chemotherapy. Data from a new pan-European survey will reveal how Erbitux® has become
the standard treatment for recurrent and/or metastatic head and neck cancer. 4
Cilengitide – Phase II study update on long-term survival in glioblastoma
Merck Serono’s oncology portfolio also includes investigational compounds such as the
integrin inhibitor cilengitide, hoped to be used in patients with glioblastoma, an aggressive
brain tumor. New information to be presented at ASCO on this integrin inhibitor will provide
the latest updates from a randomized Phase II trial in recurrent glioblastoma, including 1 - 4year survival data. 5,6
The foundations for sustained innovation
Merck Serono continues to invest in research to uncover novel treatments to further change
the landscape of cancer management. New pre-clinical data for Erbitux® provide further
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News Release
encouraging evidence of a mode of action that includes a marked antibody-dependent
cellular cytotoxicity (ADCC) activity.7 In addition, preliminary data from a Phase I study for
Merck Serono’s MEK inhibitor AS703026 in solid tumors will be presented at the meeting.8
Merck Serono’s commitment to advancing cancer care has led to collaboration with a number
of leading cancer organizations, including the National Cancer Institute in the United States.
These collaborations will provide an important basis for continued innovation and support
Merck Serono’s goal to improve treatment and outcomes for cancer patients.
*MEK: MAPK/ERK kinase:
MAPK = Mitogen-activated protein kinase
ERK = extracellular signal-regulated kinase
References :
1
Van Cutsem E, et al. ECCO/ESMO Congress 2009. Abstract No: 6077.
Ciardiello F, et al. ASCO Annual Meeting 2010; Abstract No: e14074
3 Bokemeyer C, et al. ASCO Annual Meeting 2010; Abstract No: 3506
4 Merlano MC, et al. ASCO Annual Meeting 2010; Abstract No: e16016
5 Stupp R, et al. ASCO Annual Meeting 2010; Abstract No: TPS152
6 Fink K, et al. ASCO Annual Meeting 2010; Abstract No: 2010
7 Stroh C, et al. ASCO Annual Meeting 2010; Abstract No: e13025
8 Delord JP, et al. ASCO Annual Meeting 2010; Abstract No: 2504
2
For more information on Erbitux® in colorectal, head & neck and non-small cell lung cancer, please visit:
www.globalcancernews.com.
About Erbitux®
Erbitux® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor
receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux® is distinct from standard non-selective
chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation
of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of
normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor
cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood
vessels inside tumors, which appears to lead to an overall suppression of tumor growth.
The most commonly reported side effect with Erbitux® is an acne-like skin rash that seems to be correlated with a
good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment
with Erbitux®; about half of these reactions are severe.
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News Release
Erbitux® has already obtained market authorization in 80 countries. It has been approved for the treatment of
colorectal cancer in 80 countries and for the treatment of squamous cell carcinoma of the head and neck
(SCCHN) in 77 countries:
- December 2003 (Switzerland), February 2004 (USA), June 2004 (EU) and followed by other countries: for use in
combination with irinotecan in patients with EGFR-expressing mCRC (metastatic colorectal cancer) who have
failed prior irinotecan therapy. In addition, Erbitux® is also approved for single-agent use in further countries.
- April 2006 (EU) and followed by other countries: for use in combination with radiotherapy for the treatment of
locally advanced squamous cell carcinoma of the head and neck (SCCHN). In further countries, Erbitux ® is also
approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.
- July 2008 (EU): license was updated for the treatment of patients with epidermal growth factor receptor (EGFR)
expressing, KRAS wild-type mCRC in combination with chemotherapy and as a single agent in patients who have
failed oxaliplatin-and irinotecan-based therapy and who are intolerant to irinotecan.
- July 2008 (Japan): for use in combination with irinotecan in patients with EGFR-expressing mCRC who have
failed prior irinotecan therapy
- In November 2008 (EU): license was updated for the use in combination with platinum-based chemotherapy in
patients with recurrent and/or metastatic SCCHN
- March 2010 (Japan): label extended to use in combination with chemotherapy in the 1st-line treatment for
patients with epidermal growth factor receptor (EGFR)-expressing, curatively unresectable (inoperable), advanced
or recurrent colorectal cancer (mCRC) carrying the KRAS wild-type gene.
Merck licensed the right to market Erbitux® outside the US and Canada from ImClone LLC, a wholly-owned
subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone, Bristol-Myers Squibb Company and Merck jointly
develop and commercialize Erbitux®. Merck has an ongoing commitment to the advancement of oncology
treatment and is currently investigating novel therapies in highly targeted areas, such as the use of Erbitux® in
colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer. Merck has also
acquired the rights for the cancer treatment UFT® (tegafur-uracil) – an oral chemotherapy administered with folinic
acid (FA) for the first-line treatment of metastatic colorectal cancer.
Merck is also investigating among other potential cancer treatments the use of Stimuvax ® (BLP25 Liposome
Vaccine) in the treatment of non-small cell lung and breast cancer. The vaccine was granted fast-track status in
September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc.,
Seattle, Washington, USA.
In addition, Merck is developing cilengitide, which is the first in a new class of investigational anti-cancer therapies
called integrin inhibitors to reach Phase III development; it is currently being investigated for the treatment of
glioblastoma, SCCHN and NSCLC. Integrin inhibitors are thought to work by targeting the tumor and its
vasculature.
About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt,
Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck
Serono discovers, develops, manufactures and markets innovative small molecules and
biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD
Serono operates through separately incorporated affiliates.
Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis
(Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alpha), endocrine and metabolic disorders
(Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride) as well as cardiometabolic
diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products
are available in all markets.
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News Release
With an annual R&D expenditure of more than € 1bn, Merck Serono is committed to growing its business
in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and
endocrinology, as well as new areas potentially arising out of research and development in autoimmune
and inflammatory diseases.
About Merck Korea
Merck Ltd. Korea, registered in 1989, and Merck Advanced Technologies Ltd., established in 2002, are the Merck
companies in Korea and operate in pharmaceutical and the chemical industries of Liquid Crystals, Performance &
Life Science Chemicals such as Pigments, Life Science products and Analytics. In 1999, Merck Korea set up its
Korean pharmaceutical operation. This was integrated with Serono Korea after Merck KGaA’s acquisition of
Serono S.A. in 2007. After organizing ourselves, Merck Korea set to introduce new products step by step and will
continue in the future. In addition, Merck has been increasing the number of clinical trials in Korea. Merck has a
strong relation with R&D in Korea, not only in the medical area but also in the chemical field. In 2008 Merck KGaA
decided to invest EUR 11 million in a new Advanced Technology Center (ATC) to improve Merck’s R&D and
manufacturing capacities by providing high quality products in the rapidly increasing display market, while
continuing to support customers by allowing them to achieve business success through advanced technologies
and close relationship in a rapidly changing display technology Also, this investment reconfirms Merck’s
commitment and responsibility to contribute innovative solutions for the future success of the Korean display
industry. And its inauguration ceremony is held in May 2010.
About Merck
Merck is a global pharmaceutical and chemical company with total revenues of € 7.7 billion in 2009, a history that
began in 1668, and a future shaped by approximately 33,600 employees in 64 countries. Its success is
characterized by innovations from entrepreneurial employees. Merck's operating activities come under the
umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders
own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been
an independent company ever since.
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