German Federal Joint Committee recognises added benefit of once-daily LIXIANA® (edoxaban) for preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation

Munich (ots/PRNewswire) -

Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) today
announced that the German public health agency, The Federal Joint
Committee (Gemeinsamer Bundesausschuss - G-BA), has granted an
indication of a minor additional benefit for LIXIANA® (edoxaban), an
oral, once-daily selective factor Xa inhibitor, for the prevention of
stroke and systemic embolism (SE) in patients with non-valvular
atrial fibrillation (NVAF). These findings will help to form the
basis for the continued reimbursement for LIXIANA® by statutory
health insurance providers in Germany. This recognition has been
awarded due to improved patient outcomes, noting fewer bleedings
including intracranial hemorrhages and major adverse events following
treatment with edoxaban compared to warfarin.[1] LIXIANA® is the
first once-daily novel oral anticoagulant (NOAC), for which the G-BA
has recognised an additional benefit.

Oliver Appelhans, Daiichi Sankyo Vice President and European
Launch Leader, commented, "The Federal Joint Committee's decision
reinforces the value of edoxaban for this at-risk patient population,
and is further evidence of the solid clinical foundations upon which
the treatment has been approved in countries throughout Europe." He
continued, "Daiichi Sankyo is committed to bringing innovative
medicines to patients who need them. We're excited that edoxaban is
now widely available in Europe and that regulators have consistently
recognised its value as a treatment option."

The latest Federal Joint Committee follows full approvals granted
by regulators in Scotland,[2] the UK,[3] Switzerland[4] and The
Netherlands[5] for indications in prevention of stroke and SE in
NVAF.

The Federal Joint Committee's decision is based on data from a
large scale Phase III clinical study, ENGAGE AF-TIMI 48, which
compared treatment with once-daily edoxaban to warfarin. This study
represents one of the largest single comparative trials of a novel
oral anticoagulant in this patient population, involving 21,105
patients.[6] In this study, once-daily edoxaban 60 mg demonstrated
non-inferiority to warfarin, for the primary efficacy endpoint of
occurrence of stroke or SE in patients with NVAF (1.18% vs. 1.50% per
year, respectively; hazard ratio [HR], 0.79; 97.5% confidence
interval [CI], 0.63 to 0.99, p<0.001 for non-inferiority). In
addition, once-daily edoxaban 60 mg demonstrated a significant 20%
risk reduction of major bleeding in patients with NVAF compared to
warfarin (2.75% vs. 3.43% per year, respectively; HR, 0.80; 95% CI,
0.71 to 0.91, p<0.001).[6]

AF a heart rhythm disorder in which the heartbeat is rapid and
irregular, affects over six million people across Europe.[7] People
with AF are at a five-fold increased risk of stroke compared to the
general population,[7] with an estimated financial burden of over
EUR38 billion a year.[8]

After reviewing the available evidence, The Federal Joint
Committee has indicated no additional benefit in its appraisal of
edoxaban for the prevention of VTE.[1] Oliver Appelhans commented,
"We remain committed to the use of edoxaban for the prevention of
VTE, as supported by the results of the pivotal Hokusai-VTE trial,
which demonstrated a significant 19% risk reduction of clinically
relevant bleeding in patients with VTE compared to warfarin."

About The Federal Joint Committee

The Federal Joint Committee (Gemeinsamer Bundesausschuss - G-BA)
is the highest decision-making body of the joint self-government of
physicians, dentists, hospitals and health insurance funds in
Germany. The Federal Joint Committee assesses any additional benefit
claimed by newly authorised pharmaceutical products over the
appropriate comparator within six months of the product launch. Since
2011, G-BA findings have formed the basis for price negotiations
between statutory health insurance providers and the pharmaceutical
industry for new active ingredients.

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.

Edoxaban received EU approval in June 2015 for the prevention of
stroke and SE in adult patients with NVAF with one or more risk
factors, such as congestive heart failure, hypertension, age >= 75
years, diabetes mellitus, prior stroke or transient ischaemic attack
(TIA), as well as for the treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE), and prevention of recurrent DVT and PE in
adults. Edoxaban is currently marketed in the UK, Germany,
Switzerland, the US and Japan. In other countries, regulatory review
is ongoing.

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 17,000 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 its strong
portfolio of medicines for hypertension, dyslipidemia, bacterial
infections, and thrombotic disorders, the Group's research and
development is focused on bringing forth novel therapies in
cardiovascular-metabolic diseases, pain management, and oncology,
including biologics. For more information, please visit:
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. 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.

References

1. Gemeinsamer Bundesausschuss - G-BA. Tragende Gründe. zum Beschluss
des Gemeinsamen Bundesausschusses über eine Änderung der
Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die
Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a
SGB V - Edoxaban. January 2016.
2. SMC Advice Directory. Edoxaban (LIXIANA). Available at: https://ww
w.scottishmedicines.org.uk/SMC_Advice/Advice/1095_15_edoxaban_Lixi
ana_NVAF/edoxaban_Lixiana_NVAF. (Last accessed January 2016).
3. Daiichi Sankyo press release - UK's NICE recommends once-daily
LIXIANA® (edoxaban) for preventing stroke and systemic embolism in
patients with non-valvular atrial fibrillation. 24 September 2015.
Available at: http://www.daiichisankyo.com/media_investors/media_r
elations/press_releases/detail/006354.html. (Last accessed January
2016).
4. Daiichi Sankyo press release - Daiichi Sankyo's Once-Daily
Lixiana® (edoxaban) Approved for the Prevention of Stroke and
Systemic Embolism in Non-Valvular Atrial Fibrillation and for the
Treatment and Prevention of Recurrent Venous Thromboembolism in
Switzerland. 15 April 2015. Available at: http://www.daiichisankyo
.com/media_investors/media_relations/press_releases/detail/006269.
html. (Last accessed January 2016).
5. Zorginstituut Nederland. GVS-rapport 15/12 edoxaban (Lixiana®) bij
atriumfibrilleren. 8 September 2015.
6. Giugliano R, et al. Edoxaban versus warfarin in patients with
atrial fibrillation. N Engl J Med. 2013;369(22):2093-2104.
7. Camm A, et al. Guidelines for the management of atrial
fibrillation: the Task Force for the Management of Atrial
Fibrillation of the European Society of Cardiology (ESC). Eur
Heart J. 2010;31(19):2369-429.
8. Allender S, Scarborough P, Peto V, et al. European Cardiovascular
Disease Statistics 2012 Edition.

EDX 16 0026 January 2016

Contact Lydia Worms (Europe) Daiichi Sankyo Europe GmbH Edoxaban
Communications & Product PR Europe +49(89)7808751

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
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