Global Phase III Trial With Selective c-MET Inhibitor Tivantinib (ARQ 197) Starts Enrolling Patients in Europe

Munich (ots/PRNewswire) - Daiichi Sankyo announced today
that it has begun enrolling patients in Europe into a large,
multinational phase III trial of tivantinib (ARQ 197). Tivantinib is
an investigational small molecule inhibitor of the c-MET receptor
tyrosine kinase in final phase of clinical development for the
treatment of advanced, non-squamous, non-small cell lung cancer
(NSCLC).

Lung cancer is a devastating disease. In Europe, it is one of the
most common cancers and the leading cause of cancer-related death
among men and women(1). NSCLC is the most common form, accounting for
approximately 85% of all lung cancer cases(2).

"Lung cancer is such an aggressive disease with a great unmet
need for more effective treatments. Survival rates are still very
poor when compared to other common cancer types. We are very pleased
to be involved in this trial and we hope that tivantinib will prove
to be an effective treatment option for people diagnosed with this
disease", said Prof. Giorgio Scagliotti, Head of the Department of
Clinical and Biological Sciences at S. Luigi Hospital, Orbassano
(Torino), Italy and Principal European Investigator in the trial.

The trial - known as MARQUEE (Met inhibitor ARQ 197 plus
Erlotinib vs Erlotinib plus placebo in NSCLC) - is a randomised,
double-blinded, controlled study of tivantinib plus erlotinib, versus
placebo plus erlotinib in patients who have received prior treatment
for advanced, non-squamous NSCLC. The primary objective of the study
is to evaluate overall survival (OS) in the intent-to-treat (ITT)
population*. Secondary endpoints include OS in the subpopulation of
patients with epidermal growth factor receptor (EGFR) wild type, the
time patients in the ITT population live without their disease
getting worse (progression-free survival or PFS), and further
assessment of the safety of tivantinib in combination with erlotinib.

"We are very pleased to have started enrollment in Europe and we
hope that this late-stage study will confirm the results observed
with tivantinib in phase II. Cancer is a major concern across Europe
and the world and Daiichi Sankyo is committed to the discovery and
development of oncology compounds that might help to advance cancer
treatment," said Glenn Gormley, Chief Science Officer and President,
Daiichi Sankyo Pharma Development.

The MARQUEE study will enroll 988 patients in 150 sites in the
U.S., Canada, Eastern and Western Europe, Australia and Latin
America.

About tivantinib (ARQ 197) and c-MET

ARQ 197 now has a generic name approved by the World Health
Organisation (WHO) - tivantinib. Tivantinib is an orally
administered, selective inhibitor of c-MET, a receptor tyrosine
kinase. In healthy adult cells, c-MET is present in normal levels to
support natural cellular function, but in cancer cells c-MET is
inappropriately and continuously activated for unknown reasons. When
abnormally activated, c-MET plays multiple roles in aspects of human
cancer, including cancer cell growth, survival, angiogenesis,
invasion and metastasis.

Tivantinib has the potential to be a first-in-class c-MET
inhibitor for the treatment of NSCLC and is currently being studied
for other indications including liver and colorectal cancers. In
clinical trials to date, treatment with tivantinib has been
well-tolerated and has resulted in tumor responses and prolonged
stable disease across a broad range of tumors.

In December 2008, ArQule, Inc. and Daiichi Sankyo signed a
license, co-development and co-commercialization agreement to
co-develop tivantinib in the U.S., Europe, South America and the rest
of the world, excluding Japan, China (including Hong Kong), South
Korea and Taiwan, where Kyowa Hakko Kirin Co., Ltd. has exclusive
rights for development and commercialization.

* Intent-to-treat (ITT) analysis: A method of analysis for
randomized trials in which all patients randomly assigned to one of
the treatments are analysed together, regardless of whether or not
they completed or received that treatment.

References

1 Ferlay J, Shin HR, Bray F, et al (GLOBOCAN 2008). Cancer
Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet].
Lyon, France: International Agency for Research on Cancer; 2010.
Available from: http://globocan.iarc.fr. Last accessed 11 April 2011.

2 Huq S, Maghfoor I, Perry M (Feb 2010) Lung cancer, non-small
cell. E-medicine from WebMD. Available from
http://emedicine.medscape.com/article/279960-overview. Last accessed
11 April 2011.

About Daiichi Sankyo

The Daiichi Sankyo Group is dedicated to the creation and supply
of innovative pharmaceutical products to address the diversified,
unmet medical needs of patients in both mature and emerging markets.
The company was created in 2005 through the merger of two traditional
Japanese enterprises, Daiichi and Sankyo. With net sales of nearly
EUR7.3 billion, Daiichi Sankyo is one of the world's 20 leading
pharmaceutical companies. While maintaining its portfolio of marketed
pharmaceuticals for hypertension, hyperlipidemia, and bacterial
infections, the Group is engaged in the development of treatments for
thrombotic disorders and focused on the discovery of novel oncology
and cardiovascular-metabolic therapies. Furthermore, the Daiichi
Sankyo Group has created a "Hybrid Business Model", which will
respond to market and customer diversity and optimize growth
opportunities across the value chain.

The company's world headquarters is in Tokyo. Its European base
is located in Munich. Daiichi Sankyo Europe has affiliates in 12
European countries in addition to a global manufacturing site
located in Pfaffenhofen, Germany.

For more information, please visit: http://www.daiichisankyo.com
or http://www.daiichi-sankyo.eu

Forward-looking statements

This press release contains forward-looking statements and
information about future developments in the sector, and the legal
and business conditions of Daiichi Sankyo Europe GmbH. Such
forward-looking statements are uncertain and are subject at all times
to the risks of change, particularly to the usual risks faced by a
global pharmaceutical company, including the impact of the prices
for products and raw materials, medication safety, changes in
exchange rates, government regulations, employee relations, taxes,
political instability and terrorism as well as the results of
independent demands and governmental inquiries that affect the
affairs of the company. All forward-looking statements contained in
this release hold true as of the date of publication. They do not
represent any guarantee of future performance. Actual events and
developments could differ materially from the forward-looking
statements that are explicitly expressed or implied in these
statements. Daiichi Sankyo Europe GmbH assumes no responsibility for
the updating of such forward-looking statements about future
developments of the sector, legal and business conditions and the
company.

Contact
Federico Maiardi Dr Elke Adamietz
European Product PR Manager Director Medical Affairs Oncology
Phone +49-172-8386112 Phone +49-89-7808210
Federico.maiardi@daiichi-sankyo.eu Elke.adamietz@daiichi-sankyo.eu

ots Originaltext: Daiichi Sankyo
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