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European patient registry in venous thromboembolism (VTE) - PREFER in VTE - enrols first patient

 European patient registry in venous thromboembolism (VTE) - PREFER in VTE -
                             enrols first patient

  PR Newswire

  MUNICH, February 6, 2013

MUNICH, February 6, 2013 /PRNewswire/ --

   The registry plans to gather data from more than 4,000 patients with VTE
    across seven European count ries, providing insights into the clinical
management of a disease that is a leading cause of morbidity and mortality ^[
                                    ^1 ^]

Daiichi Sankyo Europe GmbH announced the enrolment of the first patient into
the PRE vention o F thromboembolic events - E uropean R egistry in V enous T
hrombo E mbolism (PREFER in VTE). PREFER in VTE is the first patient registry
to gather comprehensive data on the quality of life and treatment satisfaction
of patients with VTE. It will also provide detailed insights into the process
of patient management in the acute treatment phase, as well as in the
prevention of repeat thromboembolic events. In addition, the PREFER in VTE
registry will investigate the economic burden of VTE treatment. 

Discussing the importance of this registry, Dr. Alexander T. Cohen, Honorary
Consultant Vascular Medicine, Department of Vascular Surgery, King's College
Hospital, London, said, "The enrolment of the first patient in this registry
is an exciting milestone. PREFER in VTE is the first registry of its kind
which will provide detailed insight into the patient's perspective. Relying
on patient interviews and diaries rather than focusing purely on a doctor's
assessment of VTE, will give us important patient data outside of a clinical
trial setting."

VTE is a leading cause of morbidity and mortality worldwide and the annual
number of VTE-related deaths has been estimated at more than 500,000 across
the EU. ^[1] Results of literature reviews have shown that VTE, and its
consequences, have considerable economic impacts on healthcare systems. ^[2]

The PREFER in VTE registry plans to enrol more than 4,000 patients with VTE
(deep vein thrombosis and/or pulmonary embolism) across approximately 400
recruiting hospitals and specialised centres, in seven major European
countries (Austria, France, Germany, Italy, Spain, Switzerland and the UK). By
collecting key data from different geographies, the registry will highlight
important risk factors and demonstrate diagnosis pathways and treatment
modalities in this patient population. The review of current therapy and
healthcare resource use will allow an evaluation of the relationship between
the use of anticoagulants and approximate therapy costs. In contrast to other
registries in this setting, PREFER in VTE is the first of its kind to also
analyse the relationship between VTE treatment and a patient's quality of life
and treatment satisfaction.

In 2012 Daiichi Sankyo Europe started another large registry, focussing on
patients suffering from atrial fibrillation (AF) - the PRE vention o F
thromboembolic events - E uropean R egistry in A trial F ibrillation (PREFER
in AF). The company has now completed the enrolment of more than 7,100
patients who will be followed up for 12 months. The first set of data will be
available in the summer of 2013.

The PREFER in VTE and PREFER in AF registries reinforce Daiichi Sankyo's
leadership in cardiovascular medicine. ^[3] Dr. Jan van Ruymbeke, CEO of
Daiichi Sankyo Europe GmbH, stated, "Daiichi Sankyo is committed to improve
patient outcomes which means applying our expertise and innovation to
providebest-in-class medicine for our patients."

About PREFER in VTE

The PREFER in VTE registry enrolled the first patient in January, 2013. The
registry is a multi-centre, prospective observational disease registry, with a
one-year follow up. The patient sample will represent patients with acute
initial or recurrent VTE (PE and/or DVT) with no exclusion criteria. Baseline
visits will be conducted by investigators and standardised patient telephone
follow-up interviews will be performed in regular intervals up to 12 months.

About PREFER in AF

The PREFER in AF registry is a multi-centre, prospective observational disease
registry, with a one-year follow up. The patient sample will represent all AF
patient groups with no exclusion criteria and irrespective of whether they
receive antithrombotic therapy or not.

A bout VT E

VTE is the term for the generation of a blood clot within a vein, or the
subsequent breaking off of that clot into a pulmonary (lung) artery. ^[4]

Deep vein thrombosis (DVT) and pulmonary embolism (PE) are the two sub-types
of VTE. ^[5] DVT is caused by a blood clot anywhere in the deep veins of the
legs, pelvis or arms. ^[6] PE is caused by a clot that detaches from the vein
and travels to the lungs, ^[6] lodging in the pulmonary arteries causing a
potentially fatal condition. ^[6],[7] PE is often accompanied by DVT and a DVT
can develop into a PE suddenly. ^[7] It is estimated that VTE is the cause of
approximately 12% of annual deaths across Europe. ^[1]

As demonstrated by data from six major European countries, VTE affects more
than 750,000 people annually. ^[1 ^] Traditional therapies are often
inconvenient and cumbersome, due to food and drug interactions as well as the
need for strict international normalized ratio (INR) monitoring.   

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. While maintaining its portfolio
of marketed pharmaceuticals for hypertension, hyperlipidemia, and infectious
diseases, the Group is engaged in the development of innovative treatments for
thrombotic disorders and focused on the discovery of novel therapies in the
designated priority research areas of oncology and cardiovascular-metabolic
therapies.

Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model,"
encompassing innovative pharmaceuticals (new drugs), established
pharmaceuticals (generics), vaccines, and OTC products, which will globally
respond to market and customer diversity and optimize growth opportunities
across the value chain.

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, Co. Ltd, DAIICHI SANKYO, Inc., and 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, Co. Ltd, DAIICHI
SANKYO, Inc., and DAIICHI SANKYO EUROPE GmbH assume no responsibility for the
updating of such forward-looking statements about future developments of the
sector, legal and business conditions and the company.

1. Cohen AT, Agnelli G, Anderson FA et al. Venous thromboembolism (VTE) in
Europe. Thromb Haemost 2007; 98:756-64.

2. Ruppert A et al. Economic burden of venous thromboembolism: a systematic
review. Journal of Medical Economics Vol. 14, No. 1, 2011: 65-74.

3. PREFER in AF Observational Plan - Daiichi Sankyo data on file. August 2011

4. Loue and Sajatovic Encyclopedia of Aging and Public Health 2008, XXIII, 843
p. 10 illus.

5. The Coalition to Prevent VTE. Available at:
http://www.coalitiontopreventvte.org/ . Accessed January 2013

6. Lung Disorders 2007By Peter B. Terry, M.D.

7. Cleveland Clinic. Venous Thromboembolism. Available at:
http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/cardiology/venous-thromboembolism/
. Accessed April 2012

Contact: For more information, please contact: Jo Taylor, Daiichi Sankyo UK,
+44 (0) 1753 893600 (Office)