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Annual Report 2009 - Daiichi Sankyo

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United States<br />

DAIICHI SANKYO, INC. (DSI)<br />

Market Trends<br />

While the United States remains the largest pharmaceutical market<br />

in the world, the expiration of patents on many major products, a<br />

decrease in the number of newly marketed products, the impact<br />

of slack economic conditions, and other factors restrained market<br />

growth in 2008 to a slower rate than that of the global market, just<br />

as in 2007.<br />

Despite the harshness of its operating environment, <strong>Daiichi</strong><br />

<strong>Sankyo</strong>, Inc. (DSI), was able to record robust sales of antihypertensive<br />

Benicar (Olmesartan), Benicar HCT*, and antihyperlipidemic<br />

agent Welchol, which was approved for the additional indication<br />

of type 2 diabetes in January 2008. In addition, sales of AZOR**<br />

showed a large increase. Consequently, DSI achieved net sales of<br />

¥129.3 billion in fiscal 2008. In local currency terms, sales amounted<br />

to US$1,286 million, up 15.8% from fiscal 2007, a growth rate<br />

considerably greater than that of the U.S. market overall.<br />

** Benicar HCT is a combination of Olmesartan and the diuretic<br />

Hydrochlorothiazide.<br />

** AZOR is a combination of Olmesartan and the calcium channel blocker<br />

Amlodipine.<br />

Further Sustained Growth in Sales of Olmesartan<br />

Antihypertensive Olmesartan is included in three products—<br />

Benicar, Benicar HCT, and AZOR. Since the 2002 launch of<br />

Benicar, Olmesartan has been considered a best-in-class<br />

antihypertensive with distinctively strong blood pressure reduction,<br />

and it has been used in the treatment of a great many<br />

patients. As part of our product life-cycle management strategy<br />

for Olmesartan, we plan to submit a New Drug Application for<br />

Joseph P. Pieroni<br />

President and CEO, <strong>Daiichi</strong> <strong>Sankyo</strong>, Inc.<br />

CS-8635—a combination of three antihypertensives: Olmesartan,<br />

Amlodipine, and Hydrochlorothiazide—to the U.S. Food and Drug<br />

Administration (FDA) during <strong>2009</strong>.<br />

Effient a Highly Promising Product<br />

On July 10, <strong>2009</strong>, the FDA approved antiplatelet agent Prasugrel<br />

(Effient) for the reduction of thrombotic cardiovascular events<br />

(including stent thrombosis) in patients with acute coronary syndrome<br />

who are managed with an artery-opening procedure<br />

known as percutaneous coronary intervention. Prasugrel is a highly<br />

promising drug that has demonstrated superior efficacy in direct<br />

comparison with Clopidogrel, which is one of the world’s topselling<br />

products and a standard product used in conventional<br />

antiplatelet therapy. DSI and its partner Eli Lilly and Company have<br />

begun co-promoting Prasugrel under the brand name Effient.<br />

Expecting Effient to be a major product, DSI had completed its<br />

sales force expansion program in advance by the end of 2008.<br />

With high-added-value products on the market and in the development<br />

pipeline in the area of cardiovascular disease, DSI continues<br />

to advance toward its goal of becoming a leader in<br />

cardiovascular therapies in the United States.<br />

DSI’s Net Sales of Key Products (¥ billion)<br />

150<br />

Benicar/Benicar HCT<br />

AZOR<br />

Welchol<br />

Others<br />

126.9 129.3<br />

100<br />

76.6<br />

110.9<br />

19.3<br />

22.7<br />

24.5<br />

2.5 8.7<br />

50<br />

14.8<br />

50.3<br />

77.2<br />

87.9<br />

87.4<br />

0<br />

FY2005*<br />

FY2006**<br />

FY2007<br />

FY2008<br />

** FY2005 results are simple totals of the figures of the U.S. subsidiaries of the former <strong>Sankyo</strong> Co., Ltd., and the former <strong>Daiichi</strong> Pharmaceutical Co., Ltd.<br />

** DSI’s FY2006 results are based on sales for 15 months (¥130.4 billion) due to a change in accounting period. To facilitate comparison, the graph has been adjusted<br />

to show a 12-month-period result.<br />

26<br />

<strong>Daiichi</strong> <strong>Sankyo</strong> Co., Ltd. <strong>Annual</strong> <strong>Report</strong> <strong>2009</strong>

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