Daiichi Sankyo Announces New Data to be Presented at the ISPOR EU Congress 2016 Analysing the Safety, Efficacy and Cost-effectiveness of LIXIANA®▼ (edoxaban)

MUNICH, October 13, 2016 /PRNewswire/ --

- Three abstracts highlight the economic burden of Venous Thromboembolism (VTE) in
Europe and provide new insights into VTE treatment with LIXIANA(R)(edoxaban)  
- Daiichi Sankyo is committed to enhancing the understanding, prevention and
treatment of VTE, and is partnering with the International Society on Thrombosis and
Haemostasis for World Thrombosis Day, 13 October  

Daiichi Sankyo Europe GmbH Group (hereafter, Daiichi Sankyo) today announced the presentation of three abstracts at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) EU Congress, 29 October - 2 November 2016, in Vienna, Austria. The data will provide insight into the safety and efficacy of once-daily LIXIANA (edoxaban) compared to rivaroxaban for the treatment of VTE[1] and the cost-effectiveness of edoxaban, compared to warfarin.[2] Analyses of health-economic data from the PREvention oF thromboembolic events - European Registry in Venous ThromboEmbolism (PREFER in VTE) registry will also be presented, giving insights into the economic burden of pulmonary embolism (PE) in terms of mortality, healthcare resource utilisation, health-related quality of life (HrQoL), and loss of productivity.[3]

Details of the abstracts being presented at the ISPOR EU Congress are included below:

- The economic burden of pulmonary embolism in Europe (Gumbs P, et al.) - 8:45 -
14:15, Monday 31 October
- An analysis of the efficacy and safety of edoxaban in comparison with rivaroxaban in
the treatment of deep vein thrombosis and pulmonary embolism (van Hout B, et al.) -
15.15 - 19.15, Tuesday 1 November
- Cost-effectiveness of edoxaban compared to warfarin for the treatment and secondary
prevention of venous thromboembolism in the UK (Clay E, et al.) - 15:15 - 19:15,
Tuesday 1 November  

"We are pleased that additional scientific evidence can help to simplify the use of once-daily Lixiana in the treatment of VTE, and to create awareness on the complexities of the economic burden it poses," said Dr Juan Carlos Jaramillo, Senior Vice President, Head of Market Access and Medical Affairs. "As an official partner of World Thrombosis Day, Daiichi Sankyo is committed to promoting broader global awareness of VTE, as we work to reduce the burden of the disease."

VTE is an umbrella term for two related conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a disease caused by a blood clot found in deep veins, usually within the lower leg, thigh or pelvis, although they can occur in other parts of the body as well.[4] PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.[5]

VTE is a major cause of morbidity and mortality.[6] In 25 EU countries VTE events exceed 1.5 million every year and the annual incidence of VTE in developed countries is estimated to be 1-3 per 1,000 adults.[7],[8] A prior incidence of a VTE is the most significant risk factor of a second occurrence, and after the age of 50, the risk doubles every ten years.[9]

To learn more about VTE, an interactive infographic can be viewed here: http://af-vte.thisinfographic.com/wtd

About Edoxaban  Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting.

The edoxaban Summary of Product Characteristics can be viewed here:http://pressportal.lixiana.com/further-content/summary-of-product-characteristics .

About Extensive Clinical Research Program for Edoxaban   Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programs evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE). The extensive edoxaban research program include multiple RCTs (randomized, controlled trials), registries and non-interventional studies, with the goal of generating new clinical and real-world-data regarding its use in AF and VTE populations. Daiichi Sankyo expects that more than 100,000 patients will participate in the edoxaban clinical research program, including completed, ongoing and future research.

The RCTs include:

- ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial
Fibrillation), in AF patients undergoing electrical cardioversion
- ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with AF undergoing PCI), in
AF patients undergoing percutaneous coronary intervention
- Hokusai-VTE Cancer (Edoxaban in Venous Thromboembolism Associated with Cancer), in
patients with cancer and an acute VTE event
- ELDERCARE-AF (Edoxaban Low-Dose for EldeR CARE AF patients), in elderly AF patients in

In addition, global and regional registry studies will provide important real-world-data about the use of edoxaban and other oral anticoagulants in everyday practice, and include:

- ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with non
valvular Atrial Fibrillation)
- ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in patients with Venous
- EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic procedures-AF/VTE);
- Prolongation PREFER in AF (PREvention oF thromboembolic events - European Registry) in
patients with AF
- ANAFIE (All Nippon AF In Elderly) Registry in Japan;

We are committed to adding to the scientific body of knowledge around edoxaban in a variety of AF and VTE patients, including those who are vulnerable.

Daiichi Sankyo Fights Thrombosis   Daiichi Sankyo is your partner in antithrombotic therapy with the discovery and development of innovative products, to help patients with a wide range of cardiovascular conditions. These include EFIENT(R) (prasugrel) for acute coronary syndromes and LIXIANA(R)  (edoxaban) for non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism. Daiichi Sankyo's ongoing commitment in this field is demonstrated by their continued investment into patient-relevant clinical development activities that aim to advance the care and improve the lives of people suffering with these diseases. For more information, please visit: http://www.daiichi-sankyo.eu.

About Daiichi Sankyo    Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: http://www.daiichisankyo.com.

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. 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. 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) van Hout B et al. An analysis of the efficacy and safety of edoxaban in comparison
with rivaroxaban in the treatment of deep vein thrombosis and pulmonary embolism.
Abstract presented at ISPOR 2016.
2) Clay E et al. Cost-effectiveness of edoxaban compared to warfarin for the treatment
and secondary prevention of venous thromboembolism in the UK. Abstract presented at
ISPOR 2016.
3) Gumbs PD et al. The economic burden of pulmonary embolism in Europe. Abstract
presented at ISPOR 2016.
4) Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) - Blood Clot Forming in a Vein.
Centers for Disease Control and Prevention. Available at:
http://www.cdc.gov/ncbddd/dvt/facts.html. Last accessed: October 2016.
5) Ozaki, A. Cleveland Clinic (2014). Venous thromboembolism. Available at:
management/cardiology/venous-thromboembolism/#s0010. Last accessed October 2016.
6) Bramlage, P. et al. Current concepts for the prevention of venous thromboembolism.
European Journal of Clinical Investigation. 2005;35(1):4-11.
7) The Coalition to Prevent VTE. Available at:
DCD0A03F_1422_16B3_78E0B9EB0571.HTM. Last accessed October 2016.
8) Braekkan, S. K. et al. Body height and risk of venous thrombo- embolism: The Tromsø
Study. American Journal of Epidemiology. 2010;171:1109-1115.
9) Zagaria, M. Venous Thrombosis: Pathogenesis and Potential for Embolism. US Pharm.


Lydia Worms (Europe) 
Daiichi Sankyo Europe GmbH 
Edoxaban Communications & Product PR Europe 


Daiichi Sankyo Company, Limited

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