Daiichi Sankyo Announces First European Approval for Sevikar HCT(R), a New Three-in-one Combination Product for the Treatment of High Blood Pressure*

By Daiichi Sankyo, PRNE
Sunday, December 19, 2010

New Treatment Option Contributes to Fight Against Hypertension, Which Affects over 30% of Adults in Europe(1)

MUNICH, December 20, 2010 - Daiichi Sankyo Europe announced today that Sevikar HCT(R) is
now approved in Germany, the first market to launch this new once-daily
three-in-one combination product for the treatment of high blood pressure
(BP). This new drug combines the three widely prescribed blood pressure
treatments - olmesartan medoxomil, amlodipine, and hydrochlorothiazide (HCT)
- in one single pill to help effectively control hypertension.(2)

The approval of Sevikar HCT(R) in Germany was granted after
the European decentralised procedure was closed with a positive
recommendation on the drug.

With the approval of Sevikar HCT(R), Daiichi Sankyo offers
physicians a comprehensive range of olmesartan based therapies to help them
to successfully treat their patients to the accepted target blood pressure of
less than 140/90 mmHg.

*Sevikar HCT(R) is indicated as substitution therapy in adult
patients whose blood pressure is adequately controlled on the combination of
olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a
dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil
and hydrochlorothiazide) and a single-component formulation (
hydrochlorothiazide or amlodipine).(3)

"The approval for Sevikar HCT(R) is good news for both
patients and physicians in Europe," said Reinhard Bauer, CEO of Daiichi
Sankyo Europe, "With olmesartan as the foundation for this new treatment
option, we are confident that Sevikar HCT(R) will provide doctors with an
additional therapy option to successfully treat their patients to blood
pressure targets."

Evidence shows that up to two-thirds of hypertensive patients
require multiple medications from different classes of treatment, and many
need three or more to reach the accepted blood pressure goal of 140/90
mmHg.(4,5,6) The fixed-dose combination therapy Sevikar HCT(R) will provide
doctors with a new treatment option to prescribe to patients, that simplifies
treatment, provides patients with a more convenient option and decreases
overall pill burden. Giving drugs as a single-pill fixed dose combination
significantly improves compliance, and favors BP control compared with the
same drugs given separately as two or more pills.(7)

The approval Sevikar HCT(R) completes the Daiichi Sankyo
portfolio for the treatment of high blood pressure. The portfolio includes:

- Olmetec(R) (olmesartan medoxomil)

- Olmetec Plus(R) q (olmesartan + hydrochlorothiazide)

- Sevikar(R) q (olmesartan + amlodipine)

- Sevikar HCT(R) (olmesartan + amlodipine +

About hypertension

Hypertension is one of the most prevalent conditions in Europe
affecting approximately one in three adults and approximately one billion
people worldwide.(8) It is often challenging to control, and of those
diagnosed with high blood pressure, approximately 65 percent do not have the
condition under control.(9)

High blood pressure can cause permanent changes to blood
vessels and the heart that may create serious problems elsewhere in the body.
We know that tight BP control, as opposed to settling for treating patients
to 5-10 mmHg above goal, can make a great deal of difference, reducing
incidence of stroke by an impressive 44% and deaths by 32%.(10)

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
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 optimise growth opportunities across the value chain. For more
information, please visit: www.daiichisankyo.com.

The company's world headquarters are in Tokyo. Its European base is
located in Munich. DAIICHI SANKYO EUROPE has affiliates in 12 European
countries in addition to a global manufacturing site located in Pfaffenhofen,

Legal disclaimer (Forward-looking statement)

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
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.. Kearney PM, et al. Kearney PM, Whelton M, Reynolds K, et al.
Worldwide prevalence of hypertension: a systematic review. J Hypertens

2. Oparil S, Melino M, Lee J, Fernandez V and Heyrman R. Triple therapy
with Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in
adult patients with hypertension: The TRINITY multicenter, randomized,
double-bline, 12-week, parallel-group study. Clin Ther 2010: 32(7); 1252-1269

3. Fachinformation Sevikar(R) HCT, Stand: Dezember 2010

4. National High Blood Pressure Education Program, JNC 7: The Seventh
Report of the Joint National Committee on Prevention, Detection, Evaluation
and Treatment of High Blood Pressure, December, 2003.

5. Cushman WC, et al. Success and predictors of blood pressure control in
diverse North Am settings: the antihypertensive and lipid lowering treatment
to prevent heart attack trial(ALLHAT). J Clin Hypertens (Greenwich).
2002;4:393- 404.

6. Hansson L, et al. Effects of intensive blood-pressure lowering and
low-dose aspirin in patients with hypertension: principal results of the
Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group.
Lancet 1998;351(9118):1755-62.

7. Mancia, G., et al. Reappraisal of European guidelines on hypertension
management: a European Society of Hypertension Task Force document. J
Hypertens;2009. 27: 2121-2158.

8. Gupta AK, Arshad S and Poulter NR. Compliance, safety, and
effectiveness of fixed-dos combinations of antihypertensive agents: a
meta-analysis. Hypertension 2010:55(2); 399-407

9. Kearney PM, Whelton M, Reynolds K, et al. Worldwide prevalence of
hypertension: a systematic review. J Hypertens 2004;22:11-19

10. Bakris, et al. Preserving renal function in Adults with Hypertension
and Diabetes: A consensus approach. Am J Kidney Dis, 2000;36(3):646-661


    Public Relations
    Dr. Michaela Paudler-Debus
    Head of Product PR Europe
    Phone +49-89-78-08-685

    Joris Versteden
    Vice Director Medical and Scientific Affairs
    Phone +49-89-78-08-497

Contact: Public Relations, Dr. Michaela Paudler-Debus, Head of Product PR Europe, Phone +49-89-78-08-685, michaela.paudler-debus at daiichi-sankyo.eu. Medical, Joris Versteden, Vice Director Medical and Scientific Affairs, Phone +49-89-78-08-497, joris.versteden at daiichi-sankyo.eu

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