Annual Report 2009 - Daiichi Sankyo

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was initially developed for patients with ACS undergoing PCI. Phase III TRITON clinical trials involving over 13,600 patients at 707 facilities in 30 countries directly compared Prasugrel with an existing drug. Prasugrel showed a significant 19% reduction in relative risk for the combined endpoint of cardiovascular death, nonfatal heart attack, or non-fatal stroke; a 30% relative risk reduction for patients with diabetes for that combined endpoint; and an approximately 50% reduction in the risk of stent thrombosis. Prasugrel also showed an increase in bleeding risk, but a riskbenefit analysis indicated a net clinical benefit. Based upon data from the TRITON trials, Daiichi Sankyo and Eli Lilly submitted a New Drug Application to the FDA in December 2007 and a Marketing Authorization Application to the European Medicines Agency (EMEA) in February 2008. Prasugrel was approved by the EC and FDA for the treatment of ACS patients managed with PCI in February 2009 and July 2009, respectively, and is now available in several European countries and the United States as a powerful new therapeutic option. Further Potential Following the TRITON trials focused on ACS patients managed with PCI, in June 2008 Daiichi Sankyo and Eli Lilly started a new Phase III TRILOGY ACS clinical trial for medically managed ACS patients. TRILOGY ACS directly compares Prasugrel with an existing drug, involving approximately 10,000 patients at more than 800 facilities in 35 countries. Leveraging the data and experience obtained through TRITON, we will continue to evaluate Prasugrel as an effective treatment for medically managed ACS patients and to maximize its potential. Currently, Phase II trials are in progress in Japan. Going forward, Daiichi Sankyo will sustain its utmost efforts to deliver its next-generation antiplatelet agent to patients worldwide as quickly as possible. 2 Strategic Move 2008 June Start of new Phase III trials (TRILOGY ACS) designed to add further indications 2008 December Approval recommendation by EMEA’s Committee for Medicinal Products for Human Use 2009 February Unanimous approval recommendation by FDA’s Cardiovascular and Renal Drugs Advisory Committee 2009 February Approval by the European Commission (EC) 2009 March Launch of Efient in the United Kingdom 2009 July Approval by FDA 2009 August Launch of Effient in the United States Daiichi Sankyo Co., Ltd. Annual Report 2009 13
STRATEGIC MOVE 3: REALIZING THE HYBRID BUSINESS MODEL Ranbaxy Joins the Daiichi Sankyo Group To realize its vision for 2015 of becoming a Global Pharma Innovator, Daiichi Sankyo has been implementing its first midterm business management plan (MTP), which covers the period from fiscal 2007 through fiscal 2009. The three-year plan aims to quickly realize the management integration synergies of Daiichi Sankyo’s predecessor companies (Daiichi Pharmaceutical Co., Ltd., and Sankyo Co., Ltd.), strengthen drug development capabilities, reinforce and expand business infrastructure to promote corporate growth, and attain various other strategic objectives. We have been implementing diverse measures in accordance with the MTP. One of these measures is the addition of Ranbaxy Laboratories Limited to the Daiichi Sankyo Group. Following the agreement entered into by Daiichi Sankyo and Ranbaxy in June 2008, Daiichi Sankyo completed its transactions to acquire the majority of voting rights in Ranbaxy in November 2008. Established in 1961, Ranbaxy has more than 12,000 employees and marketing bases in 49 countries throughout the world as well as manufacturing facilities in India, the United States, and nine other countries. In 2008, Ranbaxy recorded about Rs73.0 billion (US$1.68 billion) in consolidated sales* and maintained a wellbalanced geographic sales structure with significant contributions from markets such as India, Asia, North America, Europe, and Commonwealth of Independent States (CIS) countries. While Ranbaxy is most prominent in the field of generic drugs, it also has great potential in R&D on innovative drugs. Ranbaxy has Mr. Atul Sobti CEO and Managing Director of Ranbaxy Laboratories Limited several projects in its development pipeline, represented by an anti-malaria drug that is currently undergoing Phase III trials. * Calculated based on Indian accounting standards. Changes in the Global Drug Market In 2008, the worldwide drug market amounted to approximately US$773.1 billion, the majority of which was attributable to the developed countries of North America, Europe, and Japan. However, expiring patents on blockbusters (drugs with global annual sales exceeding ¥100 billion) and growing emphasis on With its executive leadership reconstituted, Ranbaxy will make a powerful contribution to the hybrid business model. Hybrid Business Model Developed countries (Current market size: large) Innovative (Proprietary drugs) Traditional core business Long-term sellers (Non-proprietary drugs) Cost containment Low growth rate Emerging countries (Current market size: small) Plus High growth rate Population increase, economic growth 14 Daiichi Sankyo Co., Ltd. Annual Report 2009
Page 1 and 2: DAIICHI SANKYO CO., LTD. Annual Rep
Page 3 and 4: Three Years Young— See How Much W
Page 5 and 6: CONSOLIDATED FINANCIAL HIGHLIGHTS D
Page 7 and 8: MESSAGE FROM THE PRESIDENT “We ar
Page 9 and 10: Our third challenge is to make stea
Page 11 and 12: STRATEGIC MOVE 1: EXPANDING OUR BUS
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Page 17 and 18: The hybrid business model offers at
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Page 21 and 22: Enriching the Oncology Pipeline In
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Page 29 and 30: Europe DAIICHI SANKYO EUROPE GmbH (
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Page 35 and 36: Board of Directors (As of June 26,
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Page 45 and 46: Consolidated Balance Sheets DAIICHI
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(a) 2) Purpose of acquisition To de
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15. Segment Information (1) Busines
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As described in note 2 to the conso
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17. Stock Option Plans The Company
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Individuals covered by the plan: 20
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Price information of stock options
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Independent Auditors’ Report 76 D
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(As of June 2009) Paid-in Equity Ow
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3-5-1, Nihonbashi Honcho, Chuo-ku,
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Annual Report 2009 - Daiichi Sankyo

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