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Phase 3 Data Show Daiichi Sankyo's Once-Daily Edoxaban Lowered Incidence of VTE Recurrence and Clinically Relevant Bleeding



 Phase 3 Data Show Daiichi Sankyo's Once-Daily Edoxaban Lowered Incidence of
  VTE Recurrence and Clinically Relevant Bleeding Compared to Warfarin in a
                    Large Subgroup of Patients with Cancer

  PR Newswire

  NEW ORLEANS and TOKYO, Dec. 9, 2013

- VTE patients with cancer treated with once-daily edoxaban had a numerically
lower incidence of recurrent VTE and a 36% lower risk of clinically relevant
bleeding compared to warfarin in a subgroup analysis of the phase 3
Hokusai-VTE study(1)

- In general, the annual incidence of VTE is as high as 20% in cancer patients
and contributes to increased risk of mortality(2)

- Results in this subgroup analysis are consistent with the overall phase 3
Hokusai-VTE results previously reported(1,3)

- This analysis of VTE patients with cancer was presented at the 2013 American
Society of Hematology Annual Meeting and Exposition

NEW ORLEANS and TOKYO, Dec. 9, 2013 /PRNewswire/ -- Daiichi Sankyo Company,
Limited (hereafter, Daiichi Sankyo) today announced results of a prespecified
subgroup analysis of 771 cancer patients enrolled in the phase 3 Hokusai-VTE
study. Patients with either a history of cancer (n=563) or with active cancer
(n=208) treated with the once-daily factor Xa-inhibitor edoxaban had a
numerically lower incidence of recurrent symptomatic venous thromboembolism
(VTE) compared to warfarin (3.7% vs. 7.1%, respectively; hazard ratio [HR],
0.53; 95% confidence interval [CI], 0.28 to 1.00). Once-daily edoxaban also
had a lower incidence of clinically relevant bleeding (major or non-major)
compared to warfarin in cancer patients (12.4% vs. 18.8%, respectively; HR,
0.64; 95% CI, 0.45 to 0.92).(1) These findings are consistent with the results
from the wider study population of 8,292 patients, which found once-daily
edoxaban met the primary efficacy endpoint of non-inferiority for the
treatment and prevention of VTE and superiority for the pre-specified
principal safety outcome of clinically relevant bleeding compared to
warfarin.(3) The data from this subgroup analysis of the phase 3 Hokusai-VTE
study were presented at the 2013 American Society of Hematology Annual Meeting
and Exposition in New Orleans.

"VTE is a common complication in cancer patients, and cancer patients with VTE
are at higher risk of recurrence, so we are pleased that the subgroup analysis
found that patients treated with edoxaban had a numerically lower incidence of
VTE recurrence and clinically relevant bleeding compared to warfarin," said
Gary Raskob, PhD, Dean of the College of Public Health, Professor,
Epidemiology and Medicine University of Oklahoma Health Sciences Center in
Oklahoma City, Oklahoma and member of the Hokusai-VTE steering committee.
"These findings provide us with insights about the potential benefit of
edoxaban administered once-daily compared to warfarin for the treatment and
prevention of recurrent symptomatic VTE in cancer patients."

"VTE is a major cause of morbidity and mortality in patients with cancer, with
an annual incidence that can be as high as 20% depending on the cancer type,
background risk, and time since diagnosis,"(2,4) said Harry Buller, MD, PhD,
Professor of Internal Medicine, Chairman of the Department of Vascular
Medicine at the Academic Medical Center in Amsterdam, The Netherlands and
Chairman of the Hokusai-VTE steering committee. "A promising finding was the
sizeable reduction in recurrent symptomatic VTE among cancer patients who were
treated with once-daily edoxaban."

In the subset of 208 patients with active cancer, once-daily edoxaban had a
rate of VTE recurrence of 3.7% compared to 7.1% for warfarin (HR, 0.55; 95%
CI, 0.16 to 1.85) and an incidence of clinically relevant bleeding of 18.3%
compared to 25.3% for warfarin (HR, 0.72; 95% CI, 0.40 to 1.30).(1)

"Our global Hokusai-VTE study of once-daily edoxaban included a broad range of
patients and we recognize that VTE can be a common complication of cancer, so
it´s not surprising to see that 9.3% of patients enrolled had active cancer or
a history of cancer," said Glenn Gormley, MD, PhD, Senior Executive Officer
and Global Head of Research and Development, Daiichi Sankyo Co., Ltd. and
President and CEO of Daiichi Sankyo, Inc. in the United States. "Daiichi
Sankyo is committed to help clinicians understand potential treatment
strategies for diverse patient populations with VTE."

About Hokusai-VTE Hokusai-VTE was a global, event-driven, randomized,
double-blind, parallel-group phase 3 clinical study involving 8,292 patients
in 439 clinical sites across 37 countries to evaluate once-daily edoxaban in
patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary
embolism (PE), or both. The Hokusai-VTE study was designed to reflect clinical
practice using a flexible treatment duration of three to 12 months, including
initial use of heparin, the proven global standard of care, in both arms, in a
broad spectrum of VTE patients, including those with cancer.(3)

The full results were presented at the ESC Congress 2013 in Amsterdam and
published in the New England Journal of Medicine , demonstrating that edoxaban
met the primary efficacy endpoint of non-inferiority, with a numerically lower
incidence of recurrent symptomatic VTE compared to warfarin (3.2% vs. 3.5%,
respectively) (HR, 0.89; 95% CI, 0.70 to 1.13; p<0.001 for non-inferiority)
following initial use of heparin in both arms. Recurrent symptomatic VTE was
defined as the composite of recurrent symptomatic DVT, non-fatal symptomatic
PE and fatal PE in patients during the 12-month study period. Once-daily
edoxaban was also found to be superior to warfarin for the pre-specified
principal safety outcome of clinically relevant bleeding (8.5% vs. 10.3%,
respectively) (HR, 0.81; 95% CI, 0.71 to 0.94; p=0.004 for superiority)
occurring during or within three days of interrupting or stopping study
treatment.(3)

The Hokusai-VTE study included a prespecified subgroup analysis of patients
with either a history of cancer (n=563) or with active cancer (n=208) if long
term low molecular weight heparin (LMWH) was not planned due to availability,
physician judgment or patient preference. The trial excluded patients with
active cancer for whom long term treatment with LMWH was anticipated.(3)

The study is named after the famous Japanese artist and painter Katsushika
Hokusai.

Venous Thromboembolism in Cancer Patients VTE is an umbrella term for two
conditions, DVT and PE. DVT is a blood clot found anywhere in the deep veins
of the legs, while PE occurs when part of a clot detaches and lodges in the
pulmonary arteries, causing a potentially fatal condition.(5)

In cancer patients, there is a significantly increased risk of VTE compared to
the general population due to proteins released by malignant tumors that
promote coagulation.(6) Studies have suggested that patients with cancers of
the pancreas, lung, stomach and adenocarcinomas of unknown primary origin are
at the highest risk of VTE due to the release of mucin, a protein commonly
found in these types of cancers that can contribute to coagulation through the
aggregation of platelets.(7,8) Certain anticancer therapies, such as
chemotherapy, immunomodulatory agents and antiangiogenic agents also increase
the risk of VTE in this patient population.(7)

In the general population VTE is a major cause of morbidity and mortality
worldwide with an annual incidence of approximately one per 1,000 in developed
countries, including an estimated 430,000 PE events, 680,000 DVT events and
540,000 deaths each year in the EU.(9,10) In the U.S., it is currently
estimated that more than 950,000 VTE events and approximately 300,000 VTE
related deaths occur each year.(11,12) In patients with cancer who develop
VTE, there is a four- to eight-fold higher risk of dying after an acute
thrombotic event than in patients without cancer.(7) Additionally, patients
with cancer and VTE have a lower survival rate than those without VTE.(7)

About Edoxaban Edoxaban is an investigational, oral, once-daily anticoagulant
that specifically inhibits factor Xa, which is an important factor in the
coagulation system that leads to blood clotting.(13) The global edoxaban
clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and
ENGAGE AF-TIMI 48 ( E ffective a N ticoa G ulation with Factor X A Next GE
neration in A trial F ibrillation). The results from these trials will form
the basis of New Drug Applications for edoxaban for two potential indications,
the treatment and prevention of recurrence of venous thromboembolism (VTE) in
patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and
for the prevention of stroke and systemic embolic events (SEE) in patients
with non-valvular atrial fibrillation, respectively.(3,14)

Edoxaban is currently approved only in Japan, since April 2011, for the
prevention of VTE after major orthopedic surgery, and was launched in July
2011 under the brand name Lixiana®. Elsewhere, including Europe and the U.S.,
edoxaban is currently in phase 3 clinical development and has not been
approved in any indication.(15)

About Daiichi Sankyo 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 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. For more information, please visit:
www.daiichisankyo.com .

Contact
Global Media                                     US Media
Michaela Paudler-Debus, PhD                      Alyssa Dargento
Daiichi Sankyo Europe                            Daiichi Sankyo, Inc.
michaela.paudler-debus@daiichi-sankyo.eu         adargento@dsi.com
+49-89-7808-685 (office)                         +1-973-944-2913 (office)
+49-176-11780966 (mobile)                        +1-973-727-1604 (mobile)

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) Raskob, GE et al. Edoxaban for long-term treatment Of venous
  thromboembolism in cancer patients. Presented at the 2013 American Society
  of Hematology Annual Meeting and Exposition. Abstract number 211. (2) Ay, C,
  et al. Prediction of venous thromboembolism in cancer patients. Blood 2010;
  116:5377-5382. (3) Buller, H et al. Edoxaban versus warfarin for the
  treatment of symptomatic venous thromboembolism. N Engl J Med 2013. (4)
  Lyman, GH et al. American Society of Clinical Oncology guideline:
  recommendations for venous thromboembolism prophylaxis and treatment in
  patients with cancer. Journal of Clinical Oncology 2007;25:5490-5505. (5)
  Van Beek, E et al. Deep vein thrombosis and pulmonary embolism. New York:
  John Wiley & Sons, 2009. Print. (6) Boccaccio, C et al. Genetic link between
  cancer and thrombosis. J Clin Oncol 27:4827-4833. (7) Lee, AYY, et al.
  Venous thromboembolism and cancer: Risks and outcomes. Circulation
  2003;107:I-17-I-21. (8) Wahrenbrock, M et al. Selectin-mucin interactions as
  a probable molecular explanation for the association of Trousseau syndrome
  with mucinous adenocarcinomas. J Clin Invest 112:853–862 (2003). (9)
  Bramlage P, Pittrow D, Kirch,W. Current concepts for the prevention of
  venous thromboembolism. Eur J Clin Invest 2005; 35 (Suppl. 1):4-11. (10)
  Cohen A, Agnelli G, Anderson F. Venous thromboembolism (VTE) in Europe.
  Thromb Haemost 2007; 98: 756–764. (11) Deitelzweig S, Lin J, Johnson BH,
  Schulman KL. Prevalence of venous thromboembolism in the USA: now and
  future. Thromb Haemost 2009;7 (Suppl. 2):207-8 (abstract OC-WE-018). (12)
  Heit JA, Cohen AT, Anderson FAJ, on behalf of the VTE Impact Assessment
  Group. Estimated annual number of incident and recurrent, non-fatal and
  fatal venous thromboembolism (VTE) events in the US. ASH Annual Meeting
  Abstracts. 106:910. 2005. (13) Ogata, K et al. Clinical safety,
  tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa
  inhibitor edoxaban in healthy volunteers. J Clin Pharmacol 2010;50:743-753.
  (14) Giugliano, RP et al. Edoxaban versus warfarin in patients with atrial
  fibrillation. N Engl J Med 2013. (15) Daiichi Sankyo press release - Daiichi
  Sankyo launches LIXIANA® (edoxaban), a direct oral factor Xa inhibitor, in
  Japan for the prevention of venous thromboembolism after major orthopaedic
  surgery. 19 July 2011. Available at:
  http://www.daiichisankyo.com/news/detail/004123.html . [Last accessed:
  December 2013].

Website: http://www.daiichisankyo.com
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