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  • 20 de diciembre de 2010

    Daiichi Sankyo Announces First European Approval for Sevikar HCT(R), a New Three-in-one Combination Product for the Trea

    MUNICH, December 20, 2010 /PRNewswire/ -- 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 + hydrochlorothiazide)

    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: http://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, Germany.

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

    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