MUNICH, Germany, November 12 /PRNewswire/ -- DAIICHI SANKYO EUROPE GmbH announces today that they received marketing approval for SEVIKAR(R), a new fixed dose combination treatment for essential hypertension, a condition that significantly contributes to the estimated annual EUR192 billion healthcare cost of cardiovascular disease in Europe(1). GERMANY, the European headquarter of DAIICHI SANKYO, is the latest country in Europe to grant marketing approval for SEVIKAR(R). Approvals have been obtained over a very short time period in The Netherlands, Spain, France, United Kingdom and Belgium, with further approvals imminently anticipated in other key European markets, highlighting the importance of this new medication.
SEVIKAR(R) offers significant value through clinically significant control of blood pressure combined with cost leadership position in class, allowing health authorities to maximize resource deployment.
Reinhard Bauer, CEO of DAIICHI SANKYO EUROPE GmbH said: High blood pressure is a major health concern across Europe and the world, with more than 50 percent of patients not achieving blood pressure goal. SEVIKAR(R) will allow physicians to help challenging patients reach and maintain their blood pressure goal reducing the risks of cardiovascular disease and ultimately helping to reduce the severe financial strains on health authorities.
Based on the strength of the clinical data supporting this product, DAIICHI SANKYO predicts SEVIKAR(R) will rapidly achieve significant market share within the hypertension market. SEVIKAR(R) was successfully launched in the USA in October 2007 as AZOR(TM).
The DAIICHI SANKYO portfolio of antihypertensive treatments include SEVIKAR(R), OLMETEC(R) and OLMETEC PLUS(R), which have combined global sales of EUR1.2 billion (Fiscal 2007)(2). The Olmesartan portfolio is patent-protected through to February 2017 in Europe. This portfolio will drive European corporate midterm goals of EUR1 billion sales by 2011 and will significantly contribute to DAIICHI SANKYO's aspiration to become one of the leading pharmaceutical companies in Europe by 2015.
SEVIKAR(R) is a new highly effective, once-daily, single pill fixed dose combination (FDC) of Olmesartan and Amlodipine(3). Olmesartan is widely accepted as being the most effective angiotensin receptor blocker (ARB)(4) and globally, amlodipine is the most widely prescribed anti-hypertensive treatment. Large randomised clinical studies demonstrated SEVIKAR(R) successfully treated patients with uncontrolled hypertension(3) (challenging patients) to the universally accepted blood pressure goal of less than 140/90 mmHg a threshold considered significant in reduction of cardiovascular risk (5),(6),(7).
Worldwide, hypertension may be present in almost 1 in 3 of the adult population, affecting as many as a billion people, with a figure close to 1 in every 2 people in Europe (8),(9),(10). The challenge faced in Europe is almost 2 out of every 3 hypertensive patients have uncontrolled blood pressure. These challenging patients, i.e. any patients who are not achieving blood pressure goal, are at increased risk of cardiovascular disease, adding significant, and eminently avoidable, financial burden to healthcare authorities.
The crippling affects of high blood pressure accounts for the loss of 92 million life years* and 7.6 million premature deaths worldwide, which is currently 13.5% of global total deaths(11). In Europe the impact is particularly serious with 35% of deaths and almost 1 in 5 of all life years attributed to the long-term effects of hypertension(11). Direct drug costs for treatment of hypertension, are estimated at 21% of the total cost of hypertension driven disease. In comparison, cardiovascular complications, the result on under treatment of hypertension, account for 27%, with exacerbation of co-morbidities, 52%, contributing to the majority, 79%, of hypertension driven health care budgets(12).
About DAIICHI SANKYO Company, Limited
DAIICHI SANKYO is a global pharmaceutical company that focuses on researching and marketing innovative medications. The company was created in 2005 through the merger of two traditional Japanese enterprises, Daiichi and Sankyo. With net sales of more than 5.4 billion EUR in fiscal year 2007, DAIICHI SANKYO is one of the world's 20 leading pharmaceutical companies. The company's world headquarters is in Tokyo, and its European base is located in Munich. DAIICHI SANKYO has affiliates in 12 European countries and has been one of the strongest Japanese pharmaceutical companies located in Europe since it set up European production facilities and marketing offices in 1990. The company's research activities focus on the areas of cardiovascular diseases, hematology, diabetes, anti-infectives and cancer. Its aim is to develop medications that are best in their class or to create new classes of pharmaceutical drugs.
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*Disability adjusted life years (DALYs)
Fiscal 2007 currency conversion EUR1: Yen155
References 1. Allender et al. European Heart Network 2008 2. DAIICHI SANKYO 2007 Annual Report 3. Chrysant, S.G., et al., Clin Ther, 2008. 30(4): 587-604. 4. Fabia et al. J Hypertension 2007, 25: 1327-36. 5. Mancia G, et al. J Hypertens 2007;25(6):1105-87. 6. WHO. The world health report 2002 - Reducing risks, promoting a healthy life. 7. Chobanian AV, et al.. JAMA 2003;289(19):2560-72. 8. Hyman D, Pavlik V.. NEJM. August 16 2001;345(7):479-486. 9. Wolf-Maier K, et al.. Hypertension. January 2004;43(1):10-17. 10. Wang YR, Alexander GC, Stafford RS.. Arch Intern Med 2007;167(2):141-7. 11. Lawes CM, Vander Hoorn S, Rodgers A. Lancet 2008;371(9623):1513-8. 12. Giles T.. Am J Cardiol. July 22 1999;84(2A):25k-28k.
This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of 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 EUROPE GmbH assumes no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
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