Merck Serono Announces CHMP Positive Opinion to Update Erbitux Metastatic Colorectal Cancer Labeling to Patients with RAS Wild

  Merck Serono Announces CHMP Positive Opinion to Update Erbitux Metastatic
       Colorectal Cancer Labeling to Patients with RAS Wild-type Tumors

  PR Newswire

  DARMSTADT, Germany, November 22, 2013

DARMSTADT, Germany, November 22, 2013 /PRNewswire/ --



  *CHMP recommendation comes in response to new biomarker data obtained from
    the OPUS study

Merck Serono, the biopharmaceutical division of Merck, today announced that
the European Medicines Agency's (EMA) Committee for Medicinal Products for
Human Use (CHMP) has issued a positive opinion on a variation to the Erbitux
^® (cetuximab) product information, updating the assessment of benefit-risk in
patients with metastatic colorectal cancer (mCRC). The CHMP has recommended
the approval of the indication for Erbitux in the treatment of patients with
RAS wild-type mCRC, based on the totality of data emerging on the role of mCRC
RAS tumor status in the benefit-risk profile of the drug. The recommendation
primarily refers to new biomarker data from the OPUS study. ^[1]

In recent analyses of studies evaluating monoclonal anti-EGFR antibodies such
as Erbitux, tumor samples of patients with KRAS wild-type tumor status (exon
2) were assessed for additional RAS mutations (defined as mutations in exons 3
or 4 of KRAS and/or exons 2, 3 or 4 of NRAS). The results from these studies
indicate that patients with RAS wild-type tumors may benefit from treatment
with Erbitux, while patients with RAS mutant tumors may not.

"We are pleased with this important evolution of the label for Erbitux based
upon new emerging data from our previous and ongoing studies of patients
living with colorectal cancer," said Dr. Annalisa Jenkins, Head of Global
Research and Development for Merck Serono. "As the molecular basis and
understanding of disease evolves we are committed to embracing the principles
of patient-centric drug development and personalized medicine."

Based on the CHMP's recommendation and pending agreement of the European
Commission, Erbitux will be indicated for the treatment of patients with
epidermal growth factor receptor-expressing, RAS wild-type mCRC in combination
with irinotecan-based chemotherapy, in 1st line in combination with FOLFOX, or
as a single agent in patients who have failed oxaliplatin- and
irinotecan-based therapy and who are intolerant to irinotecan. In this label
change, the combination of Erbitux with oxaliplatin-containing chemotherapy
would be contraindicated for patients with mutant RAS mCRC or for whom RAS
mCRC status is unknown.

About the OPUS Study

OPUS (OxaliPlatin and cetUximab in firSt-line treatment of mCRC) is a
randomized, controlled, Phase II trial, involving 337 mCRC patients, 179 with
KRAS wild-type (exon 2) tumors, demonstrating the efficacy of Erbitux plus
FOLFOX-4 (oxaliplatin-based therapy) versus FOLFOX-4 alone. ^[2] Results of a
RAS tumor status analysis have been submitted for presentation at
Gastrointestinal Cancers Symposium (ASCO GI) 2014.

About Colorectal Cancer

Colorectal cancer (CRC) is the fourth most common cancer worldwide, with an
estimated incidence of more than 1.2 million cases globally. ^[3] An estimated
608,000 deaths from CRC occur worldwide each year, accounting for 8% of all
cancer deaths and making it the fourth most common cause of death from cancer.
^[3] Almost 60% of the cases occur in developed regions, and incidence and
mortality rates are substantially higher in men than in women. ^[3] In Europe
alone, an estimated 436,000 people develop CRC every year, with approximately
212,000 people dying from the disease annually. ^[4]

References

1.Tejpar S et al. Submitted to 2014 Gastrointestinal Cancers Symposium,
    January 16-18, 2014.
2.Bokemeyer C, et al. Ann Oncol 2011;22(7):1535-46.
3.Ferlay J, et al. Int J Cancer 2010;127(12):2893-917.
4.Ferlay J, et al. Eu J Cancer 2010;46(4):765-81.

For more information on Erbitux in colorectal and head & neck cancer, please
visit: http://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.

Erbitux has already obtained market authorization in 93 countries. It has been
approved for the treatment of colorectal cancer in 93 countries and for the
treatment of squamous cell carcinoma of the head and neck (SCCHN) in 91
countries.

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 Serono

Merck Serono is the biopharmaceutical division of Merck. With headquarters in
Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to
help patients with cancer, multiple sclerosis, infertility, endocrine and
metabolic disorders as well as cardiovascular diseases. In the United States
and Canada, EMD Serono operates as a separately incorporated subsidiary of
Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription
medicines of both chemical and biological origin in specialist indications. We
have an enduring commitment to deliver novel therapies in our core focus areas
of neurology, oncology, immuno-oncology and immunology.

For more information, please visit http://www.merckserono.com .

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Merck is a leading pharmaceutical, chemical and life science company with
total revenues of € 11.2 billion in 2012, a history that began in 1668, and a
future shaped by approx. 38,000 employees in 66 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.

Contact: Dr. Raphaela Farrenkopf, Phone +49-(0)6151-72-2274,
raphaela.farrenkopf@merckgroup.com
 
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