Merck to Collaborate with Sysmex Inostics on a Blood-Based RAS Biomarker Test

Darmstadt, Germany (ots/PRNewswire) -

- Development and commercialization agreement on blood-based RAS biomarker
mutation status test for (metastatic) colorectal cancer (mCRC)
- This non-invasive, fast and easy-to-perform diagnostic test is expected to
provide a real-time reflection of a patient's RAS mutation status to help guide
clinical decision making in mCRC

Merck announced today that the company has signed an agreement to
collaborate with Sysmex Inostics GmbH, Hamburg, Germany, for the
development and commercialization of a blood-based RAS biomarker test
for patients with metastatic colorectal cancer (mCRC). This global
agreement was formally signed at a ceremony coinciding with the 50th
Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago, U.S.

(Photo: http://photos.prnewswire.com/prnh/20140601/689906 )

Blood-based biomarker testing is a faster and easier approach for
determining the mutation status of tumors as it requires a small
blood sample rather than a tissue biopsy procedure.[1] The test has
the potential to provide mutation status results within days, which
in turn can help guide treatment decisions.[1] In addition, it may
become the method of choice where a tissue biopsy is difficult to
obtain, for example in patients whose physical condition does not
allow for a surgical procedure.

"We are delighted to announce our strategic partnership with
Sysmex Inostics," said Belén Garijo, President and CEO of Merck
Serono. "As a company, we have embraced the principles of
personalized medicine and predictive biomarkers. This collaboration
reflects our commitment to leveraging our expertise in personalized
medicine and predictive biomarkers in order to enhance Erbitux's
value proposition for patients, physicians and payers."

"We are looking forward to this important collaboration with Merck
Serono and to bringing our innovative technology to mCRC patients,"
said Fernando Andreu, CEO of Sysmex Inostics. "Together, with our
non-invasive, blood-based diagnostics and Merck's expertise in
personalized medicine, we will open up new possibilities to advance
biomarker testing in mCRC. This collaboration is another major step
in enhancing the clinical value of Sysmex Inostics's OncoBEAM tests
and exemplifies Sysmex's overall strategy to bring sensitive
blood-based testing to the oncology field."

A biomarker test is a simple way of looking at the type and status
of particular genes of interest in a cancer.[2],[3] Biomarkers have
been found for many different types of cancer such as colorectal,
breast and lung cancer, and have an increasingly important role in
helping physicians to tailor care and treatment for their patients,
known as 'personalized medicine'.[2-4] RAS - a predictive biomarker -
is a group of genes that includes KRAS and NRAS and can be used to
help select the most appropriate therapy for each individual mCRC
patient.[5-9] Currently, biomarker testing has been performed with
tissue taken directly from the tumor itself, requiring an invasive
biopsy, to ensure that the genes from the tumor can be isolated.
However, recent technological advances embraced by Sysmex using blood
samples allows very small amounts of circulating tumor DNA to be
isolated and tested.

"In mCRC, RAS has been identified as a key biomarker that can help
predict how well mCRC patients may respond to particular treatments,
making it important to know their RAS status as early as possible,"
commented Professor Sabine Tejpar, Digestive Oncology Unit,
University Hospital Gasthuisberg, Leuven, Belgium. "As this test is
potentially faster and easier to perform, this could mean quicker and
more timely treatment decisions - supporting the ultimate goal of
improved outcomes for patients."

Approximately half of patients with mCRC have RAS wild-type tumors
and half have RAS mutant tumors.[10] Results from studies assessing
RAS mutation status in patients with mCRC have shown that
anti-epidermal growth factor receptor (EGFR) monoclonal antibody
therapies, such as Erbitux(R) (cetuximab), can improve outcomes in
patients with RAS wild-type mCRC.[5-9]

About Colorectal Cancer

Colorectal cancer (CRC) is the second most common cancer
worldwide, with an estimated incidence of more than 1.36 million new
cases annually.[11] An estimated 694,000 deaths from CRC occur
worldwide every year, accounting for 8.5% of all cancer deaths and
making it the fourth most common cause of death from cancer.[11]
Almost 55% of CRC cases are diagnosed in developed regions of the
world, and incidence and mortality rates are substantially higher in
menthan in women.[11]

References

1) Diaz LA and Bardelli A. J Clin Oncol. 2014;32(6):579-86.
2) Moorcraft SY, et al. Therap Adv Gastroenterol 2013;6(5):381-95.
3) Ong FS, et al. Expert Rev Mol Diagn 2012;12(6):593-602.
4) Mallman MR, et al. EPMA J 2010;1(3):421-37.
5) Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.
6) Schwartzberg LS, et al. J Clin Oncol 2014; March 31 [Epub ahead of print].
Available online: http://www.ncbi.nlm.nih.gov/pubmed/24687833. Last accessed April
2014.
7) Bokemeyer C, et al. Oral presentation at the 2014 American Society of
Clinical Oncology Annual Meeting, May 30-June 3, 2014.
8) Stintzing S, et al. European Cancer Congress 2013:Abstract No:LBA17.
9) Ciardiello F, et al. Oral presentation at the 2014 American Society of
Clinical Oncology Annual Meeting, May 30-June 3, 2014.
10) Vaughn CP, et al. Genes Chromosomes Cancer. 2011;50(5):307-12.
11) Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M,
Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality
Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for
Research on Cancer; 2013. Available at: http://globocan.iarc.fr. Last accessed
April 2014.

Notes to Editors

For more information on predictive biomarkers in colorectal
cancer, please visit: http://www.globalcancernews.com.

About Sysmex Inostics

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a
molecular diagnostic company whose core competency is mutation
detection utilizing highly sensitive technologies such as
Plasma-Sequencing and BEAMing. With BEAMing being one of the most
sensitive and quantitative technologies available today for the
detection of tumor specific somatic mutations in blood samples,
Sysmex Inostics' BEAMing services are readily available to support
clinical trials and research in oncology. Furthermore, Sysmex
Inostics companion diagnostics (CDx) team offers services for the
development of non-invasive plasma DNA based IVD tests supported by a
growing network of partners to cover the entire IVD development
process. In addition, BEAMing tests (OncoBEAM) are available through
a CLIA certified laboratory for routine clinical analysis.

Sysmex Inostics' headquarters are located in Hamburg, Germany and
Sysmex Inostics' Clinical Laboratory is located in Baltimore,
Maryland. For more information on OncoBEAM blood testing and the
BEAMing technology refer to http://www.sysmex-inostics.com or email
info@sysmex-inostics.com.

About Erbitux

Erbitux(R) 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.

Erbitux has already obtained market authorization in over 90
countries for the treatment of colorectal cancer and for the
treatment of squamous cell carcinoma of the head and neck (SCCHN).

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.

About Merck

All Merck Press Releases are distributed by e-mail at the same
time they become available on the Merck Website. Please go to
http://www.merckgroup.com/subscribe to register online, change your
selection or discontinue this service.

Merck is a leading company for innovative and top-quality
high-tech products in the pharmaceutical and chemical sectors. With
its four divisions Merck Serono, Consumer Health, Performance
Materials and Merck Millipore, Merck generated total revenues of EUR
11.1 billion in 2013. Around 38,000 Merck employees work in 66
countries to improve the quality of life for patients, to further the
success of customers and to help meet global challenges. Merck is the
world's oldest pharmaceutical and chemical company - since 1668, the
company has stood for innovation, business success and responsible
entrepreneurship. Holding an approximately 70 percent interest, the
founding family remains the majority owner of the company to this
day. Merck, Darmstadt, Germany is holding the global rights to the
Merck name and brand. The only exceptions are Canada and the United
States, where the company is known as EMD.

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ots Originaltext: Merck KGaA
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Contact: Gangolf Schrimpf, Phone +49-6151-72-9591