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

Munich (ots/PRNewswire) -

The registry plans to gather data from more than 4,000 patients
with VTE across seven European countries, 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 PREvention oF thromboembolic events - European
Registry in Venous ThromboEmbolism (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 that 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 (DVT) and/or pulmonary embolism (PE))
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, as well as 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, a patient's quality of life and
treatment satisfaction.

In 2012, Daiichi Sankyo Europe GmbH started another large
registry, focussing on patients suffering from atrial fibrillation
(AF) - the PREvention oF thromboembolic events - European Registry in
Atrial Fibrillation (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 provide best- in-class medicine for our
patients."

Daiichi Sankyo discovered and is currently studying edoxaban, a
novel once-daily oral factor Xa inhibitor, as a potential new
treatment option for the prevention of stroke and systemic embolic
events (SEE) in patients with non-valvular atrial fibrillation
(NVAF). It is also being developed for the potential treatment and
prevention of recurrence of VTE in patients with DVT and/or
PE.[4],[5]

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.

About VTE 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.[6] DVT and PE are the two sub-types of
VTE.[7] DVT is caused by a blood clot anywhere in the deep veins of
the legs, pelvis or arms.[8] PE is caused by a clot that detaches
from the vein and travels to the lungs,[8] lodging in the pulmonary
arteries causing a potentially fatal condition.[8],[9] PE is often
accompanied by DVT and a DVT can develop into a PE suddenly.[9] 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 AF

AF is an abnormal rhythm of the heart.[10] The heart has four
chambers - two atria and two ventricles.[11] The atria pump blood
into the ventricles and the right ventricle pumps blood around the
body; they therefore have to work in sequence for the heart to pump
blood most effectively with each heartbeat.[11]

A normal heart pumps blood with a regular rhythm - it can beat
quickly or slowly but the interval between beats is the same.[11]
When a patient suffers from AF, numerous electrical pulses that fire
from the heart muscles in the atria override the normal controlling
'timer' in the heart.[11] When this happens, the atria contract
rapidly, but only partially, and as a result pump blood less
effectively.[11]

Consequently, blood is not pumped effectively from the atria,
which may cause the blood to stagnate and form clots. These blood
clots can break off and travel through the blood stream e.g. to the
brain, where they have the potential to cause a stroke.[11]

About Edoxaban

Edoxaban is licensed only in Japan for the prevention of venous
thromboembolism (VTE) after major orthopaedic surgery, under the
brand name Lixiana(R).

Elsewhere, including Europe and the U.S., edoxaban is currently in
phase 3 of clinical development and has not yet been approved.
Daiichi Sankyo continues to develop edoxaban at a global level as a
potential new treatment for the prevention of SEE in patients with
NVAF and for the treatment and prevention of recurrence of VTE in
patients with acute DVT and/or PE.

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. Clinicaltrials.gov: NCT00781391. Global Study to Assess the
Safety and Effectiveness of DU-176b vs Standard Practice of Dosing
With Warfarin in Patients With Atrial Fibrillation (EngageAFTIMI48)
[Last accessed May 2012]. Available at: http://clinicaltrials.gov/ct2
/show/NCT00781391?term=ENGAGE++AF-TIMI+48&rank=1

5. Clinicaltrials.gov: NCT00986154. Comparative Investigation of
Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus
(LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein
Blood Clots and/or Lung Blood Clots.(The Edoxaban Hokusai- VTE
Study).[Last accessed: July 2012]. Available at: http://www.clinicalt
rials.gov/ct2/show/NCT00986154?term=hokusai&rank=1

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

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

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

9. Cleveland Clinic. Venous Thromboembolism. Available at: http://
www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/cardiology
/venous-thromb oembolism/ [http://www.clevelandclinicmeded.com/medic
alpubs/diseasemanagement/cardiology/venous-thromboembolism ] .
Accessed April 2012

10. NHS Choices. Atrial Fibrillation. Available at http://www.nhs.
uk/conditions/Atrial-fibrillation/Pages/Introduction.aspx. Last
accessed January 2013

11. Patient.co.uk http://www.patient.co.uk/pdf/pilsL10.pdf. Last
accessed January 2013

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For more information, please contact: Daria Munsel, Daiichi
Sankyo Europe GmbH, +49(89)7808728 (Office)