interview with dr. hager, page 11 (2012)

Global Patio 2012 vol .20COMPANY JOURNAL FOR COMMUNICATION

CEO’s WILL …… 03

Leveraging First-Rate Capabilities and Businesses to Fully Develop Group-Wide Synergies

Daiichi Sankyo R&D …… 07

Overview of Initiatives to Strengthen the Group’s R&D

From Each R&D Base

First-Rate Capabilities and Businesses to Fully DevelopGroup-WideSynergies

Leveraging

Joji NakayamaRepresentative Director,President and CEO

CEO’s WILL

Special Interview

vol. 20I n d e x

03 CEO’s WILL

Global Patio

Leveraging World-Class Skillsto Generate R&D Results

● DS R&D Division● ASB Asubio Pharma Co., Ltd.

● DSRDN Daiichi Sankyo RD Novare Co., Ltd.

● DSPD Daiichi Sankyo Pharma Development

● ASB-US Asubio Pharmaceuticals, Inc.

● PLX Plexxikon Inc.

● U3 U3 Pharma GmbH

● DSD Daiichi Sankyo Development Limited

● TCRM Daiichi Sankyo Tissue and Cell Research Center Munich

● RCI Daiichi Sankyo Life Science Research Center in India

● DSID Daiichi Sankyo India Development

Leveraging First-Rate Capabilities and Businesses to Fully Develop Group-Wide Synergies

07Overview of Initiatives to Strengthen the Group’s R&D

From Each R&D Base

Daiichi Sankyo R&D

26Fiscal 2011 Business Results/Fiscal 2012 Forecasts

Our Financial Performance

Topics from the World19Global TRILOGY ACS Results Regarding Prasugrel Were

Announced

Global Enjoy Dr. Jokichi Takamine Video Program

From Malaysia Celebrating 30 Years in Malaysia

From China “China-Japan Hospital Infection Management Summit Forum 2012” Has Achieved a Complete Success

From Japan Establish Strategic Collaboration to Develop and Commercialize Biosimilar Candidates

From Japan Launch of TENELIA®, A DPP-4 Inhibitor for Type 2 DM

From Mexico First Innovative Products Were Marketed in Mexico

From Venezuela Expand Hybrid Business in Venezuela

From EU Raise the Curtain for Daiichi Sankyo Europe at the ESC Congress 2012

From EU Jan Van Ruymbeke to Become New CEO of Daiichi Sankyo Europe

From U.S. Dedication Ceremony for Packaging Facility in Bethlehem

From U.S. President Nakayama Visits Asubio Pharmaceuticals in the United States

From U.S. Authorized Generic of Pioglitazone in the U.S. Launched

The Belgian Executive Replaces Reinhard Bauer in October

Global Patio: Aims and Objectives

A s w e w o r k t o b e c o m e a G l o b a l Pharma Innovator, the aim of Global Patio is to disseminate management policies and plans and create a sense of uni ty among the personnel o f the Daiichi Sankyo Group.

Editorial Policy

● To communicate the Daiichi Sankyo Group’s strengths and foster pride in its activit ies through providing a broad perspective on the Group’s global accomplishments

● To share diverse sets of values● To create opportunities for creating

new and shared values

*About Patio: In Spanish as well as English and other languages, the word “patio” refers to the interior courtyard of a house or other building. This newsletter has been given the name Global Patio because it is designed to be akin to “a place where employees and visitors can freely gather and engage in communication with each other.”

Staff

PublisherCorporate Communications Depart-ment, DAIICHI SANKYO CO., LTD.

Editorial StaffMichiko HaradaKiyoshi Kaneko

ProductionJapan Business Art

Send Us Your FeedbackWe value your input on this issue. Did it help you to better know our Group? W a s t h e c o n t e n t s p r e s e n t e d i n a reader-friendly manner? Please send your comments [email protected]

Special Interview

30 Corporate Slogan

Global Patio 2012 vol. 20 03Global Patio 2012 vol. 2002

In view of these challenges and achievements, what are

the Daiichi Sankyo Group’s objectives with respect to the Hybrid Business Model?

The Daiichi Sankyo Group’s core busi-nesses are in the fields of innovative phar-maceutical products and generic pharma-ceutical products. Our Hybrid Business Model entails combining these two “busi-ness axes” of global development with additional “regional axes” of global devel-opment, and we anticipate that our strate-gies for realizing effective execution of this business model will lead to Group business success.

Daiichi Sankyo’s strengths in the core business fields of innovative and generic drugs represent a sturdy foundation for staunchly supporting our overall business operations. If we did not have powerful capabilities in both the innovative and generic pharmaceutical fields, we would not be positioned to successfully imple-ment our Hybrid Business Model strate-gies.

In view of the environment during the period of the Second Mid-term Business Management Plan, I believe we must further strengthen our innovative pharma-ceutical business, which accounts for a very high share of the Group’s sales and profit. Despite the extremely harsh condi-tions in the European and U.S. markets, I see a potential for achieving considerable further expansion of our olmesartan fran-chise, for example. Since the success of our innovative pharmaceutical business will be largely determined by our ability to maintain a strong product portfolio, moving ahead with measures to increase our R&D productivity and augment our lineup of outstanding products which are developed in-house is the key to the Dai-ichi Sankyo Group’s survival as a dynamic

Only six months are now left in this fiscal year, the final

year of the Second Mid-term Business Management Plan. Looking back, what do you think of our performance during the first two years of the plan?

First of all, I am keenly aware of the considerable gap between the Mid-term Business Management Plan goals we set two years ago and our current performance forecast for fiscal 2012. It is important to comprehensively understand the factors that have caused the gap and use that understanding to design appropriate coun-termeasures in our next Mid-term Business Management Plan. These factors include both external and internal factors.

Looking at the external factors, one note-worthy factor is the nature of conditions in the global economy. Currency exchange rate fluctuations, particularly yen apprecia-tion, have had a large impact on our sales and profitability, and market growth in industrialized countries has begun slacken-ing against the backdrop of the measures being taken to restrain healthcare-related expenditures. For example, European coun-tries have restrained pharmaceutical prices by large margins, and the growing presence of generics in the U.S. market has been changing the special characteristics of the overall market, including for original drugs. This situation is having a large impact on Daiichi Sankyo’s business development, leading to an inevitable deceleration in Olmesartan product sales growth and making it impossible to realize our profit-ability growth target for fiscal 2011.

Internal factors include the obstacles encountered with respect to our marketing strategy for Effient®/Efient®, delays in the development schedules for global mainstay products, and a lack of success in fully leveraging Group synergies. Within the Daiichi Sankyo Group, Ranbaxy is the core

unit responsible for achieving growth in the generic drug business. However, the negotiations with the U.S. Food & Drug Administration (FDA) and Department of Justice (DOJ) have been protracted, pre-venting us from realizing business growth at the pace we had anticipated. It can be said that the generation of additional syner-gies must be positioned as one of the Dai-ichi Sankyo Group’s top objectives going forward.

On the other hand, what are the Group’s achievements?

Our recent achievements include the upgrading and expansion of our product portfolio, the strengthening of our R&D pipeline, and the broadening of our busi-ness scope. In an innovation-oriented busi-ness field, the ability to realize growth in mainstay product sales is a principal deter-minant of profitability. Since fiscal 2010, we have launched numerous new products in the Japanese market that have great growth potential—such as Memary®, Rezaltas®, NEXIUM®, and Lixiana® (edoxaban)—and we can expect an addi-tional surge of growth in the sales of such products in the future. Moreover, we are making steady progress in the development of edoxaban, one of the biggest mainstay products currently in our pipeline. In addi-t ion, our March 2011 acquisi t ion of Plexxikon Inc. was an important step ahead in our strategy for upgrading and expand-ing our pipeline as a means of strengthen-ing our position in the oncology field.

We have also established new compa-nies with an eye to broadening our busi-ness scope. These include Daiichi Sankyo Espha Co., Ltd., which we established in 2010 to serve as a core unit for our generic drug business in Japan. In the vaccine area, in Japan we established Kitasato Daiichi Sankyo Vaccine Co., Ltd., in 2011, and our joint venture with GSK K.K., Japan Vac-cine Co., Ltd., began operations in July 2012.

Q

Q

Q

Looking Back at the Second Mid-term Business Management Plan

Optimal Strategies for Achieving Success with the Hybrid Business Model

CEO's WILL

enterprise. While progressively reevaluat-ing our product pipeline and portfolio, we will continuously address new “team inno-vation” challenges involving combinations of business development and licensing initiatives as a means of becoming an enterprise capable of providing a still greater number of outstanding products that fulfill important needs in markets throughout the world.

At the same time, we must do what it takes to foster the sustained growth of the Group’s generic drug business centered on Ranbaxy. To launch our fundamental generic drug business on an upward trajec-tory, we are aiming to make the most of our strong capabilities for securing first-to-file (FTF) 180-day sales exclusivity periods in the United States.

To reinforce our operations in each busi-ness field, it is important that we consoli-date the Group’s “functional” capabilities and augment our cooperative utilization of those resources in a way that promotes synergies. While buttressing our strengths in the innovative drug business, we have to employ strategies for synergistically lever-aging those strengths to fortify our generic drug business centered on Ranbaxy. As Ranbaxy proceeds with the development of its generic drug business, we must find ways to facilitate that development through the use of know-how associated with Dai-ichi Sankyo’s innovative drug business. These are key objectives for the next Mid-term Business Management Plan.

It would be futile to attempt to realize synergies by combining second-rate busi-nesses with other second-rate businesses. What we must strive for is the generation of powerful, Groupwide synergies through the combination of first-rate innovative drug businesses with first-rate generic businesses.

So, what needs to be done regarding regional axes of

global development?With respect to regional axes of global

development, the key areas are Japan and

India, the countries in which the head offices of Daiichi Sankyo and Ranbaxy are located. Because we have established particularly strong corporate brands in those key areas, we are well positioned to develop businesses other than our innovative and generic drug businesses. Moreover, as Dai-ichi Sankyo and Ranbaxy are leading repre-sentatives of the pharmaceutical industry in their respective countries, they have an especially deep commitment to making con-tributions to better health among the popula-tions of those countries. Recognizing that, as I mentioned previously, conditions in the U.S. and European pharmaceutical markets are extremely harsh, and, noting that the associated challenges related to resource dispersion and attainment of profitability present high hurdles for us to surmount, we are not currently considering moves to broaden the scope of our operations in those markets to include such business fields as OTC drugs or vaccines.

I believe that the key to success lies in fully leveraging the Daiichi Sankyo Group’s special strengths in each region. In Japan, for example, our special strengths are natu-rally in the innovative drug business. The Second Mid-term Business Management Plan anticipated that innovative drug busi-ness would continue to account for a high share of the Group’s profitability, and that we are positioned to realize further growth centered on our strong innovative drug busi-ness in Japan. By effectively leveraging the Daiichi Sankyo brand, we are working to

supplement our innovative drug business with other businesses in Japan, including established drugs, OTC drugs, and vaccines. By marshaling these four businesses, we will be able to meet diverse medical needs.

If we consider health from a nationwide perspective, it is apparent that day-to-day health management and preventive mea-sures are increasingly important, and this suggests that there is room for the growth of the OTC and vaccine businesses in Japan. We are in a strong position to engage in the OTC business along with innovative prescription drug business, as this combina-tion of businesses enables us to offer such switch-OTC products as Loxonin S®, which we launched last year in Japan. By making the most of this superior capability that competing OTC drugmakers lack, we intend to revitalize Japan’s OTC market.

Regarding the vaccine business in Japan, we have been undertaking high-speed business-creation measures. Established in April 2011, Kitasato Daiichi Sankyo Vac-cine Co., Ltd., provides the Daiichi Sankyo Group with an extremely large production base, and it also constitutes a crucial part of Japan’s public health infrastructure in that it has the role of helping protect the health of everyone in Japan in the case of a pandemic. Aiming to reinforce our vaccine business product pipeline, we moved to establish Japan Vaccine Co., Ltd. With the coopera-tion of our partner in that joint venture—GlaxoSmithKline K.K.—we are both bolstering our own product pipeline and

positioning ourselves to make important contributions to the safety and health of everyone in Japan.

With respect to Daiichi Sankyo Espha, we are building on the solid foundation of trust established by the Daiichi Sankyo Group and aiming to realize business growth in cooperation with Ranbaxy going forward.

By combining our strengths related to functional and regional axes of global busi-ness development in these ways, we intend to realize sustained growth as a true hybrid business enterprise.

Please tell us your ideas about management directions

in the future.As I have already mentioned, the world’s

business environments and market charac-teristics are undergoing dramatic changes. Business models and values of the past will not work anymore. In such an era of great changes, we can expect to encounter special challenges in individual countries—for example, we may see drug prices reduced in some countries and find it almost impos-sible to obtain drug approvals in others. If such changes advance further, it may become impossible to fully meet the needs of different countries with a single business model. Going forward in this era, I believe that our business model, which is capable of meeting diverse needs, will become an increasingly important strength.

Our efforts to develop the Hybrid Busi-ness Model have already positioned us to more effectively respond to changes. Another essential capability for us is the ability to move ahead from concepts to functions and from visions to strategies. The main task for us going forward will be keenly monitoring market changes while striving to design the specific business

development methods that are the most effective in light of those changes. I believe it is crucial for us to manage our businesses based on a solid understanding of frontline, operational issues with decisions in both appropriate and speedy fashions.

Do you have anything special to say from a personal per-

spective to employees on the front lines of Daiichi Sankyo Group opera-tions who are preparing to proceed with the implementation of the Group’s strategies?

Our efforts to develop operations based on the global management structure during the Second Mid-term Business Management Plan have been bearing fruit, and I have the feeling that Group employees have firmly adopted global perspectives regarding their work as well as other things. What is needed now is for each and every one of us to strive to brush up our skills and further heighten our consciousness levels. It is important for us to strive to understand markets from the perspective of a sophisticated global busi-nessperson, and polish the skills we will need to respond promptly to whatever changes we discern. For example, the orga-nizational restructuring measures imple-mented in April this year included the estab-lishment of the Global Brand Strategy Department within the Corporate Strategy Division of Daiichi Sankyo. This is because, besides the creation of measures for rein-forcing product portfolios, our product strat-egies in an era of dramatic changes must also encompass new approaches and mea-sures for making the most of those products in individual types of business operations. Regardless of our current job assignments, we must all be striving to keep aware of a broad spectrum of changes and be prepared to work concertedly with our colleagues in response to them. It is extremely important that, in addition to being specialists, we endeavor to be broad-minded people ready and poised for timely dynamism.

In conclusion, could you offer us your ideas about what em-

ployees should keep in mind?To ensure that each of the Group’s busi-

nesses is a first-rate business and that Dai-ichi Sankyo continues to be an enterprise capable of consistently providing outstand-ing products that satisfy market needs, we must relentlessly address new challenges.

I have prepared four key phrases that I believe are useful to keep in mind in this connection. The first is “ Keeping market competition in mind,” which means that we should meticulously examine the changing characteristics of market environ-ments and competition as we reconfirm the optimal actions to take. Next is “speed up,” which means that we must accelerate PDCA (plan-do-check-act) cycles for determining and assessing the most-effective measures for responding to changes. Third is “Best use of time and money,” which means that regardless of the amount, when we use company money, we have to take it as seriously as when we use our own money. This thinking should also be applied to time management. The last phrase is “Think, think, think.” We should always be reassessing our familiar, conventional ideas and reconfirming whether they are still correct at this new point in time. This phrase reminds me how important it is to always maintain the mental flexibility needed to respond to new developments. The concept suggested by this fourth phrase is truly a crucial concept for us to repeatedly remind ourselves of as we address the fast-changing market envi-ronment. I hope to see all of you putting these concepts into practice for the sake of keeping the Daiichi Sankyo Group moving onward and upward.

Q

Global Patio 2012 vol. 1916 Global Patio 2012 vol. 20Global Patio 2012 vol. 20 05Global Patio 2012 vol. 2004

In view of these challenges and achievements, what are

the Daiichi Sankyo Group’s objectives with respect to the Hybrid Business Model?

The Daiichi Sankyo Group’s core busi-nesses are in the fields of innovative phar-maceutical products and generic pharma-ceutical products. Our Hybrid Business Model entails combining these two “busi-ness axes” of global development with additional “regional axes” of global devel-opment, and we anticipate that our strate-gies for realizing effective execution of this business model will lead to Group business success.

Daiichi Sankyo’s strengths in the core business fields of innovative and generic drugs represent a sturdy foundation for staunchly supporting our overall business operations. If we did not have powerful capabilities in both the innovative and generic pharmaceutical fields, we would not be positioned to successfully imple-ment our Hybrid Business Model strate-gies.

In view of the environment during the period of the Second Mid-term Business Management Plan, I believe we must further strengthen our innovative pharma-ceutical business, which accounts for a very high share of the Group’s sales and profit. Despite the extremely harsh condi-tions in the European and U.S. markets, I see a potential for achieving considerable further expansion of our olmesartan fran-chise, for example. Since the success of our innovative pharmaceutical business will be largely determined by our ability to maintain a strong product portfolio, moving ahead with measures to increase our R&D productivity and augment our lineup of outstanding products which are developed in-house is the key to the Dai-ichi Sankyo Group’s survival as a dynamic

Only six months are now left in this fiscal year,, the final

year of the Second Mid-term Business Management Plan. Looking back, what do you think of our performance during the first two years of the plan?

First of all, I am keenly aware of the considerable gap between the Mid-term Business Management Plan goals we set two years ago and our current performance forecast for fiscal 2012. It is important to comprehensively understand the factors that have caused the gap and use that understanding to design appropriate coun-termeasures in our next Mid-term Business Management Plan. These factors include both external and internal factors.

Looking at the external factors, one note-worthy factor is the nature of conditions in the global economy. Currency exchange rate fluctuations, particularly yen apprecia-tion, have had a large impact on our sales and profitability, and market growth in industrialized countries has begun slacken-ing against the backdrop of the measures being taken to restrain healthcare-related expenditures. For example, European coun-tries have restrained pharmaceutical prices by large margins, and the growing presence of generics in the U.S. market has been changing the special characteristics of the overall market, including for original drugs. This situation is having a large impact on Daiichi Sankyo’s business development, leading to an inevitable deceleration in Olmesartan product sales growth and making it impossible to realize our profit-ability growth target for fiscal 2011.

Internal factors include the obstacles encountered with respect to our marketing strategy for Effient®/Efient®, delays in the development schedules for global mainstay products, and a lack of success in fully leveraging Group synergies. Within the Daiichi Sankyo Group, Ranbaxy is the core

unit responsible for achieving growth in the generic drug business. However, the negotiations with the U.S. Food & Drug Administration (FDA) and Department of Justice (DOJ) have been protracted, pre-venting us from realizing business growth at the pace we had anticipated. It can be said that the generation of additional syner-gies must be positioned as one of the Dai-ichi Sankyo Group’s top objectives going forward.

On the other hand, what are the Group’s achievements?

Our recent achievements include the upgrading and expansion of our product portfolio, the strengthening of our R&D pipeline, and the broadening of our busi-ness scope. In an innovation-oriented busi-ness field, the ability to realize growth in mainstay product sales is a principal deter-minant of profitability. Since fiscal 2010, we have launched numerous new products in the Japanese market that have great growth potential—such as Memary®, Rezaltas®, NEXIUM®, and Lixiana® (edoxaban)—and we can expect an addi-tional surge of growth in the sales of such products in the future. Moreover, we are making steady progress in the development of edoxaban, one of the biggest mainstay products currently in our pipeline. In addi-t ion, our March 2011 acquisi t ion of Plexxikon Inc. was an important step ahead in our strategy for upgrading and expand-ing our pipeline as a means of strengthen-ing our position in the oncology field.

We have also established new compa-nies with an eye to broadening our busi-ness scope. These include Daiichi Sankyo Espha Co., Ltd., which we established in 2010 to serve as a core unit for our generic drug business in Japan. In the vaccine area, in Japan we established Kitasato Daiichi Sankyo Vaccine Co., Ltd., in 2011, and our joint venture with GSK K.K., Japan Vac-cine Co., Ltd., began operations in July 2012.

Broad-Minded Specialists, Dynamically Keeping in Step with the AcceleratingPace of Change

CEO's WILL

enterprise. While progressively reevaluat-ing our product pipeline and portfolio, we will continuously address new “team inno-vation” challenges involving combinations of business development and licensing initiatives as a means of becoming an enterprise capable of providing a still greater number of outstanding products that fulfill important needs in markets throughout the world.

At the same time, we must do what it takes to foster the sustained growth of the Group’s generic drug business centered on Ranbaxy. To launch our fundamental generic drug business on an upward trajec-tory, we are aiming to make the most of our strong capabilities for securing first-to-file (FTF) 180-day sales exclusivity periods in the United States.

To reinforce our operations in each busi-ness field, it is important that we consoli-date the Group’s “functional” capabilities and augment our cooperative utilization of those resources in a way that promotes synergies. While buttressing our strengths in the innovative drug business, we have to employ strategies for synergistically lever-aging those strengths to fortify our generic drug business centered on Ranbaxy. As Ranbaxy proceeds with the development of its generic drug business, we must find ways to facilitate that development through the use of know-how associated with Dai-ichi Sankyo’s innovative drug business. These are key objectives for the next Mid-term Business Management Plan.

It would be futile to attempt to realize synergies by combining second-rate busi-nesses with other second-rate businesses. What we must strive for is the generation of powerful, Groupwide synergies through the combination of first-rate innovative drug businesses with first-rate generic businesses.

So, what needs to be done regarding regional axes of

global development?With respect to regional axes of global

development, the key areas are Japan and

India, the countries in which the head offices of Daiichi Sankyo and Ranbaxy are located. Because we have established particularly strong corporate brands in those key areas, we are well positioned to develop businesses other than our innovative and generic drug businesses. Moreover, as Dai-ichi Sankyo and Ranbaxy are leading repre-sentatives of the pharmaceutical industry in their respective countries, they have an especially deep commitment to making con-tributions to better health among the popula-tions of those countries. Recognizing that, as I mentioned previously, conditions in the U.S. and European pharmaceutical markets are extremely harsh, and, noting that the associated challenges related to resource dispersion and attainment of profitability present high hurdles for us to surmount, we are not currently considering moves to broaden the scope of our operations in those markets to include such business fields as OTC drugs or vaccines.

I believe that the key to success lies in fully leveraging the Daiichi Sankyo Group’s special strengths in each region. In Japan, for example, our special strengths are natu-rally in the innovative drug business. The Second Mid-term Business Management Plan anticipated that innovative drug busi-ness would continue to account for a high share of the Group’s profitability, and that we are positioned to realize further growth centered on our strong innovative drug busi-ness in Japan. By effectively leveraging the Daiichi Sankyo brand, we are working to

supplement our innovative drug business with other businesses in Japan, including established drugs, OTC drugs, and vaccines. By marshaling these four businesses, we will be able to meet diverse medical needs.

If we consider health from a nationwide perspective, it is apparent that day-to-day health management and preventive mea-sures are increasingly important, and this suggests that there is room for the growth of the OTC and vaccine businesses in Japan. We are in a strong position to engage in the OTC business along with innovative prescription drug business, as this combina-tion of businesses enables us to offer such switch-OTC products as Loxonin S®, which we launched last year in Japan. By making the most of this superior capability that competing OTC drugmakers lack, we intend to revitalize Japan’s OTC market.

Regarding the vaccine business in Japan, we have been undertaking high-speed business-creation measures. Established in April 2011, Kitasato Daiichi Sankyo Vac-cine Co., Ltd., provides the Daiichi Sankyo Group with an extremely large production base, and it also constitutes a crucial part of Japan’s public health infrastructure in that it has the role of helping protect the health of everyone in Japan in the case of a pandemic. Aiming to reinforce our vaccine business product pipeline, we moved to establish Japan Vaccine Co., Ltd. With the coopera-tion of our partner in that joint venture—GlaxoSmithKline K.K.—we are both bolstering our own product pipeline and

positioning ourselves to make important contributions to the safety and health of everyone in Japan.

With respect to Daiichi Sankyo Espha, we are building on the solid foundation of trust established by the Daiichi Sankyo Group and aiming to realize business growth in cooperation with Ranbaxy going forward.

By combining our strengths related to functional and regional axes of global busi-ness development in these ways, we intend to realize sustained growth as a true hybrid business enterprise.

Please tell us your ideas about management directions

in the future.As I have already mentioned, the world’s

business environments and market charac-teristics are undergoing dramatic changes. Business models and values of the past will not work anymore. In such an era of great changes, we can expect to encounter special challenges in individual countries—for example, we may see drug prices reduced in some countries and find it almost impos-sible to obtain drug approvals in others. If such changes advance further, it may become impossible to fully meet the needs of different countries with a single business model. Going forward in this era, I believe that our business model, which is capable of meeting diverse needs, will become an increasingly important strength.

Our efforts to develop the Hybrid Busi-ness Model have already positioned us to more effectively respond to changes. Another essential capability for us is the ability to move ahead from concepts to functions and from visions to strategies. The main task for us going forward will be keenly monitoring market changes while striving to design the specific business

development methods that are the most effective in light of those changes. I believe it is crucial for us to manage our businesses based on a solid understanding of frontline, operational issues with decisions in both appropriate and speedy fashions.

Do you have anything special to say from a personal per-

spective to employees on the front lines of Daiichi Sankyo Group opera-tions who are preparing to proceed with the implementation of the Group’s strategies?

Our efforts to develop operations based on the global management structure during the Second Mid-term Business Management Plan have been bearing fruit, and I have the feeling that Group employees have firmly adopted global perspectives regarding their work as well as other things. What is needed now is for each and every one of us to strive to brush up our skills and further heighten our consciousness levels. It is important for us to strive to understand markets from the perspective of a sophisticated global busi-nessperson, and polish the skills we will need to respond promptly to whatever changes we discern. For example, the orga-nizational restructuring measures imple-mented in April this year included the estab-lishment of the Global Brand Strategy Department within the Corporate Strategy Division of Daiichi Sankyo. This is because, besides the creation of measures for rein-forcing product portfolios, our product strat-egies in an era of dramatic changes must also encompass new approaches and mea-sures for making the most of those products in individual types of business operations. Regardless of our current job assignments, we must all be striving to keep aware of a broad spectrum of changes and be prepared to work concertedly with our colleagues in response to them. It is extremely important that, in addition to being specialists, we endeavor to be broad-minded people ready and poised for timely dynamism.

In conclusion, could you offer us your ideas about what em-

ployees should keep in mind?To ensure that each of the Group’s busi-

nesses is a first-rate business and that Dai-ichi Sankyo continues to be an enterprise capable of consistently providing outstand-ing products that satisfy market needs, we must relentlessly address new challenges.

I have prepared four key phrases that I believe are useful to keep in mind in this connection. The first is “ Keeping market competition in mind,” which means that we should meticulously examine the changing characteristics of market environ-ments and competition as we reconfirm the optimal actions to take. Next is “speed up,” which means that we must accelerate PDCA (plan-do-check-act) cycles for determining and assessing the most-effective measures for responding to changes. Third is “Best use of time and money,” which means that regardless of the amount, when we use company money, we have to take it as seriously as when we use our own money. This thinking should also be applied to time management. The last phrase is “Think, think, think.” We should always be reassessing our familiar, conventional ideas and reconfirming whether they are still correct at this new point in time. This phrase reminds me how important it is to always maintain the mental flexibility needed to respond to new developments. The concept suggested by this fourth phrase is truly a crucial concept for us to repeatedly remind ourselves of as we address the fast-changing market envi-ronment. I hope to see all of you putting these concepts into practice for the sake of keeping the Daiichi Sankyo Group moving onward and upward.

Q

Q

Q（Interviewer）

Noriaki IshidaCorporate Officer and Vice President,Corporate Communications Department

Daiichi Sankyo Development Limited

Daiichi Sankyo Tissue and Cell Research Center Munich

Daiichi Sankyo India Pharma Private Limited

Daiichi Sankyo India Development

Daiichi Sankyo Life Science Research Center in India

Daiichi Sankyo Co., Ltd.

Daiichi Sankyo RD Novare Co., Ltd.

Asubio Pharma Co., Ltd.

Asubio Pharmaceuticals, Inc.

Plexxikon inc.

Daiichi Sankyo, Inc.

Daiichi Sankyo Pharma Development

Daiichi Sankyo Europe GmbH

U3 Pharma GmbH

We want to be first. We want to be in the front wave. We want to create whole new medicines. We want to offer best-in-class medicines. This is why we are dedicating our passion for R&D. World-class innovation is here.

Daiichi Sankyo

R&D

Major R&D Base

Global Patio 2012 vol. 20Global Patio 2012 vol. 20 07Global Patio 2012 vol. 2006

Leveraging World-Class Skills to Generate R&D Results

n every field of research we commit to at Daiichi

Sankyo, it is important that we always challenge our-

selves to be on the leading edge of science and under-

stand how to translate basic research into clinical benefit that

meets the needs of the patients we serve and is recognized by

health care providers around the world for the value it provides.

To achieve this objective, we must relentlessly work to develop

and maintain world-class research and development skills; this

is the key to our success. We must foster an environment

within R&D in which all members work together and share in-

formation without boundaries between functions, regions, and

teams. We must be connected to our partners in every division

of the company, such as Pharma Tech, Supply Chain, and

Commercial. Only together can we bring our innovative sci-

ence to patients. It is very important that every member of

R&D can feel comfortable respectfully challenging each other,

including their senior management. Challenge and debate is

the essence of the scientific process. Everyone involved with

R&D must have a good understanding of our strategies and

priorities in order to focus our resources on the best projects

and avoid unnecessary waste.

ver the past few months, I have outlined three goals

that I believe are critical to achieving the Daiichi

Sankyo mission to be a Global Pharma Innovator.

To meet these goals, we will all have to work together and

practice disruptive thinking, where we re-think the way we

work, take smart risks, and embrace creativity and innovation

that challenges the status quo.

My first goal is to focus on developing strong leadership

skills at all levels within R&D. To be successful with our pro-

grams, we must have leaders who can set strategy, execute

plans efficiently, listen carefully to feedback, and take ac-

countability to make tough decisions. Developing and improv-

ing these skills will require training and practice.

My second goal is to speed up decision making by creating

an empowered organization. We must trust our teams to make

good decisions quickly and carefully by utilizing the experi-

ence and talent around them. We should encourage teams to

take risks that will accelerate programs and demonstrate the

value of our projects as early as possible. At the same time, it

is important to respect and value the senior safety net that is

provided by TR/GEMRAD and led by our most-experienced

leaders.

My third goal is to strengthen and expand the value of our

R&D portfolio. To do this, I believe we must focus on these

three things: ① enrich our portfolio with true first-in-class

drugs based on new science, novel mechanisms, and innova-

tion, ② become a leader in the area of personalized medicine

by developing the right drugs for the right patients at the right

time, and ③ enhance communication and collaboration

within and between discovery and development units around

the world. We are continuing to give priority to the fields of

oncology and cardiovascular metabolism, where we see the

need for new innovative medicines. However, we also recog-

nize that science and medicine are advancing rapidly in many

areas, often in unexpected ways. In order to remain flexible to

take advantage of new emerging science, we continue to give

priority to our Frontier research teams as well. In each of these

areas, we will pursue both small molecules and biologics,

wherever science takes us.

Global Head of R&D Senior Executive Officer

Glenn Gormley, MD, Ph.D.

s we look back on the success of the first and

second mid-term plans (MTPs) (2007-12), we have

much to be proud of. Now as we look ahead to the

third mid-term plan and beyond to 2020, we should not under-

estimate the challenges ahead. Our industry is undergoing

rapid change; R&D productivity is declining and health au-

thorities are becoming more focused on safety than ever

before. To be successful in the years to come, we must con-

tinuously reinvent ourselves by adopting new ways to work.

We must become more efficient and at the same time more

productive. We will need to embrace change without compro-

mising our unique culture that defines Daiichi Sankyo.

Our third MTP will challenge us to increase the number of

new approvals each year by increasing the number of projects

in clinical development and increase the number of research

themes within discovery. If we can deliver these targets with

enhanced efficiency, we can ensure the success of our Com-

pany and meet the expectations of the patients who depend on

us to extend and improve their lives. Together, I know we can

do this.

Expectations Regarding Global R&D

Global R&D Priorities

Strategies for the Period through Fiscal 2015

Overview of initiatives to strengthen the Group’s R&D

I am passionate about improving the health and

comfort of the patients who depend on us. I want to find a way to get the right drug to the right patient at the right

time. This is why I have often said that Daiichi Sankyo

should be a leader in personalized medicine.

“

”I

O

A


R&D

R&D Division

R&D Planning Department

Global Project Management Department

R&D Administration and Support Department

Research Oversight FunctionBiologics Research Laboratories

Lead Discovery & Optimization

Research Laboratories I

Lead Discovery & Optimization

Research Laboratories II

Oncology Research Laboratories

Cardiovascular Metabolics

Research Laboratories

Frontier Research Laboratories

Biological Research Laboratories

Drug Metabolism

& Pharmacokinetics

Research Laboratories

Medicinal Safety Research Laboratories

Translational Medicine &

Clinical Pharmacology Departm

ent

Clinical Development Departm

ent I

Clinical Development Departm

ent II

Clinical Data & Biostatistics Department

New Drug Regulatory Affairs Department

Asia Development Departm

ent

Japan Development Oversight Function

Organization Chart of DS R&D Division

Vice President of the Translational Medicine & Clinical Pharmacology （TMCP）Department, R&D Division

Dr. Taro Tokui

Group 2, Oncology Research Laboratories, R&D Division

Dr. Martin H. Hager

Priority Areas in Terms of R&D Stages

Late-stage development

Life-cycle management and markets

Early-stage developmentResearch

• Hypertension• Bacterial infections• Hyperlipidemia

• Thrombotic disorders

Discovery

New AreasDrug creation based on disease mechanisms, developing products with new mechanisms of action that address heavily unmet needs

Priority Areas• Oncology　　• Cardiovascular metabolics

DS R&D Division

Message from a Researcher

FROM EACH R&D BASE

R&D Activities Being Conducted in Japant is known that the levels of drugs’ efficacy and side effects sometimes differ considerably from patient to patient. The reasons for this include cases in which the

disease itself is not homogeneous as well as cases in which a drug’s in vivo pharmacokinetic processes (absorption, distribu-tion, metabolism, and excretion) and functional targets (receptors and signaling pathways) are affected by the genetic variability among individuals. Now that the entire nucleotide sequence of the human genome has been elucidated, it has become possible to generate benefits by accurately predicting whether drugs will be therapeutically effective for individual patients and by adjusting and optimizing drug doses. The level of these benefits is expected to increase going forward. As a result of technological innovation related to genome sequencing, we are making rapid progress in promoting person-alized medicines in the oncology field through such initiatives as those to redefine individual cancers at the molecular level, create molecular-targeted drugs that target gene mutations, diagnose patients based on biomarkers, and simultaneously develop diagnostic agents and therapeutic drugs. By using bio-markers that indicate cancer cell gene mutations and the expression level of target molecules, it has become possible to select patients for which drugs can be expected to be effective as well as to develop drugs with high levels of therapeutic effi-cacy. On the other hand, regarding patients for which drugs are not expected to be effective, we can now prevent the administra-

tion of ineffective drugs and more quickly move to use alterna-tive therapeutic methods. Personalized medicine also has merits with respect to drug development—because it enables high therapeutic efficacy rates, we can reduce the scale of Phase 3 clinical trials and more quickly launch new drugs. One of Daiichi Sankyo’s early initiatives in this area relates to the c-Met inhibitor tivantinib, which we are developing in cooperation with U.S.-based ArQule, Inc. During Phase 2 clinical trials for the treatment of non-small cell lung cancer and of liver cancer, it became evident that tivantinib was highly effective for treating patients with high expression levels of the target mol-ecule c-Met, and we are now advancing with development pro-cesses while considering the possibility of selecting patients based on their c-Met expression levels. The TMCP Department considers biomarker research and clinical pharmacology research to be inseparable and complemen-tary activities. Our mission is to employ knowledge gained through nonclinical and clinical research to identify target molecules and biomarkers, verify the pharmacological concept of drug candidate compounds, and support the approval and commercialization of new drugs. Another part of our mission is to using informatics as well as modeling and simulation techniques to gain a better under-standing of the relationship between drug targets and diseases so that we can provide individual patients with the drugs that are the most appropriate for them and administer individual drugs to the patients who are the most likely to benefit from them.

Realize the Benefits of Personalized Medicine

An Oncology Expert Is Tackling the Challenges of Developing Targeted Therapies

Developments in science impact the pharmaceutical industry. In recent years, personalized medicine has attracted rising attention mostly in oncology and Daiichi Sankyo is tackling it. TMCP Department and other organizations are working to realize the future drug discovery that will lead to new bio markers and companion diagnostic drugs.

he R&D Division located in Japan collaborates closely with operations around the world in all the stages from drug discovery to development to discover and develop value-added first-in-class and best-in-class therapies

expanding on our legacy of quality and innovation to improve patient health and raise global standards for disease treatment and prevention. To this end, we are working as a multinational team under a global decision-making system, while making allowance for the different parameters of the R&D environment in each region. In late-stage development, we focus our resources mainly on the development of thrombosis. Meanwhile, to reinforce the competitiveness of research in the disease areas which have high unmet medical needs, we focus our resources on oncology and cardiovascular metabolics as the priority areas in our solid foundation that has been built up over the years. We also have established a “Novel Category”, which we are challenging through the new mid- and long-term approach in preparing for 2015 and beyond. In the novel category, we do not always follow the existing framework of the disease category, but focus discovery research based on the frontier knowledge of the pathological mechanism, and aspire to create first-in-class medicines in the remain-ing unmet medical needs.

y whole career has been revolving around oncology and how to improve cancer treatments. My father died

from cancer, which was an event that motivated me to dedicate myself to oncology research. I want to help people suffering from cancer, and so, after undertaking specialized oncology training at leading cancer hospitals in the U.S., I have come to Daiichi Sankyo. I felt that Daiichi Sankyo was the perfect company for me to work at, as I am involved in a broad spectrum of oncol-ogy research ranging from target identification to lead compound generation and even early clini-cal development. I hope to contribute new ideas to the entire oncology drug discovery process.　Currently, I am leading a research project fo-cused on developing new drugs for treating

M

We are seeking to gain a good understanding of the relation-ships between diseases and

drug-target molecules so that we can quickly provide patients with

new drugs.

“

”

We need to connect scienceand medicine — it’s what motivates me every day.

“”

TI

lymphoma, a hematological cancer. I am respon-sible for a collaboration with our partner ArQule, Inc. in Boston and other international research organizations with respect to kinase in-hibitors, and this experience is especially grati-fying as it allows me to interact with specialists across a wide range of research disciplines. One thing I can do to advance Daiichi Sankyo’s drug discovery capabilities is to pres-ent numerous proposals based on patients’ per-spectives in a speedy manner. It is crucial to ensure that the drugs we are researching are really the drugs that patients are hoping for. As a specialist who has been involved in oncology research for many years, I will continue to em-phasize patient benefits as I seek out new drug discovery challenges.

Topics


R&D

Administrator

ハイライト表示

Administrator


Administrator


History1979 Foundation of Suntory Institute for

Biomedical Research2002 Incorporation by a company split up from

Suntory Limited2010 Reorganization as a new company and

commencement of business

Number of Employees Approx. 200

Overview of ASB

Message from the Top

Pursuing Innovation on the Path to Launching Original New Drugs

subio Pharma is a team of drug discov-ery experts that specializes in R&D ac-tivities from the exploratory research

stage to the proof of concept (POC) confirmation stage. We are aiming to contribute to the Daiichi Sankyo Group’s drug discovery capabilities by promoting a free and vigorous corporate culture and maintaining an organiza-tion that facilitates agile re-sponsiveness to changing situations. This culture and structure enables our re-searchers to spontaneously come up with unique insights in their research work and to operate as a team that is con-tinually focused on leading-edge programs designed to generate first-in-class drugs that meet unmet medical needs. This is the way that we intend to contribute to the Group’s overall growth. Asubio Pharma’s strengths reflect our success-ful recruitment of outstanding researchers. I con-sider my most-important task is to support those researchers’ efforts to freely conceive new con-cepts and use those concepts to produce innova-tion. Accordingly, all of our units have completely flat organizational structures that have no supe-rior or subordinate positions. Rather than guiding or managing, the leaders of each unit are focused on creating an environment that facilitates re-searchers’ work and on supporting that work. To further increase the dynamic productiveness of

President & CEO

Seiichi Yokoyama

our R&D work, we have adopted a project-oriented organizational system and are continu-ally working to maintain management methods and organizational culture that are appropriate for R&D work. Because many of our R&D themes are extremely challenging, we have to seek a means of reinforcing our researchers’ moti-

vation, including measures to offer meaningful work, pleas-ant and cheerful workplaces, and an organization that pro-motes employees’ personal development. Through these initiatives, we are endeavor-ing to encourage all our staff to intellectually interact and cross-fertilize their ideas as

they pursue new concepts. We are also aiming for open innovation and emphasizing collaboration with outside re-search institutions. Asubio Pharma is situated in the Kobe Biomedical Innovation Cluster, which has attracted more than 200 medicine and health related companies and organizations, including academic research organizations as well as bio-venture firms. Facilitating active exchanges among researchers from different organizations, the cluster is an ideal location for Asubio Pharma’s leading-edge research programs. While making the most of this excellent envi-ronment, we will continually address new chal-lenges and changes as we strive to launch origi-nal new drugs.

The most-important thing is to realize inno-

vation based on researchers’ freedom to conceive and promote

new concepts.

ASB Asubio Pharma Co., Ltd.

“

”

A


Core businesses● Custom production of research materials and

intermediates for drug discovery and development

● Contract assay development and quantitative and/or qualitative analysis of drug substances

● Technology-based drug discovery support and alliance

● Consultation for the evaluation and application of the novel technological platform for drug discovery

● Contract clinical development

FoundationLocationNumber of Employees

Oct. 2006Tokyo, JapanApprox. 300

Overview of DSRDN

DSRDN

Strengthening Technology Platforms and Aiming to Be Irreplaceable R&D Solution Providers

egarding DSRDN’s role in upgrading the Daiichi Sankyo Group’s drug discovery power, we are addressing the issue of

how to increase the productivity and speed of R&D programs. By providing a fundamental drug discovery platform and managing high-quality clinical development program processes, we are seeking to provide strong support to Daiichi Sankyo’s R&D Division as well as to other Group com-panies. Drug discovery research is a field in which individual re-searchers’ creativity and free-dom of initiative play impor-tant roles. In recent years, however, progress in life sci-ences and analytical tech-nologies has caused drug discovery processes to become increasingly complex while also boosting associated costs. DSRDN is consolidating the Group’s fundamental technologies for research and offering a streamlined platform for the early drug discovery operations ranging from assay development and the HTS campaign to hit vali-dation, supplemented with biological evaluation and MOA analysis. By integrating various tech-nologies, we are seeking to solve intractable tech-nological problems associated with drug discov-ery research while also constantly keeping abreast with the most-advanced life science and analysis technologies so that we can effectively contribute to the discovery of first-in-class drugs. Because we are providing technological support as an independent functional company, we are strongly positioned to clearly manifest our tech-

President

Dr. Hideyuki Haruyama

nological capability and earn a proper evaluation of our performance. At the same time, in view of projections of increasingly harsh competition from other pharmaceutical companies, we must also address the need to further increase our com-petitive capability with respect to both technolo-gies and cost.

The underlying strengths of DSRDN stem from our indi-vidual technologies applied to drug discovery programs, including our gene/protein analysis group, which is earning a high evaluation both within and outside the Daiichi Sankyo Group; our highly experienced research-ers enabling highly reproduc-ible biological evaluation and

pharmacological testing; and our synthetic chem-ists, who have sophisticated skills to design novel and effective synthetic routes. Going forward, we will continue striving to make the most of these strengths within our organization. Rather than merely complying with requests from Daiichi Sankyo’s R&D Division and other Group companies, we are endeavoring to operate as a “solutions provider” that proposes improved work methods. By continually seeking to offer beneficial proposals, and by executing our tasks in ways that generate improved results and earn us strong trust and confidence from our col-leagues, we will be doing our utmost to make a substantial contribution to the augmentation of the Daiichi Sankyo Group’s drug discovery capa-bility going forward.

In October 2011, Daiichi Sankyo RD Novare Co., Ltd. (DSRDN), was established to serve as the Daiichi Sankyo Group’s research and development platform. DSRDN’s president, Dr. Hideyuki Haruyama, explained how his company will be contributing to augmenting the Group’s drug discovery power as well as the direction of his company’s development going forward.

We are confident that we can enhance

DSRDN’s brand by providing beneficial

solutions to technologi-cal challenges associ-

ated the drug discovery.

Daiichi Sankyo RD Novare Co., Ltd.

“

”

R


R&D

History1999 Founded in Fort Lee, NJ as Suntory Pharmaceutical, Inc.

and initiated clinical development of Carperitide for acute respiratory distress syndrome

2002 Initiated the clinical development of Piclozotan for acute ischemic strokes

2004 Changed the company name to Daiichi Asubio pharma-ceuticals, Inc. and moved the office to former location in Rochelle Park, NJ

2005 Initiated the clinical development of SUN11031 for cachexia

2006 initiated the clinical development of SUN13834 in atopic dermatitis and of Piclozotan in Parkinson’s disease

2007 Changed the company name to Asubio Pharmaceuticals, Inc.

2008 Proof of concept study of Parkinson’s disease com-pleted for Piclozotan

2009 Proof of concept study of atopic dermatitis completed for SUN13834 and initiated the clinical development of SUN13837 for acute spinal cord injury

2010 Proof of concept study of cachexia completed for SUN11031

2011 Moved the office to current location in Paramus, NJ and initiated the clinical development of ASB17061 for atopic dermatitis

LocationNumber of Employees

Paramus, NJ26 (Sept. 1, 2012)

Overview of ASB-US

Develop First-in-Class Drugs to Meet Unmet Medical Needs

subio Pharmaceuticals, Inc., is a small early stage clinical development company located in the U.S. focusing on adding value to the novel new chemical entities and biolog-

ics discovered at its parent company’s research facilities in Kobe, Japan. Our mission is: Make the concept of our products clear and select the most-suitable indication(s) for the first in human study, prove the concept by conducting clinical studies, and transfer the products with POC to Daiichi Sankyo to make important therapies available to pa-tients around the world. Our strength rests in the diverse scientific knowledge, expertise, and the teamwork of our clinical development teams. Our manage-ment and scientists have extensive backgrounds and experience in con-ducting clinical trials and preparing pharmaceutical products for com-mercialization. Fantasy, Passion and Vocation are my favorite key words for drug development. To accomplish our mission, we respect a culture of co-operation and teamwork not only within the company but also with our parent company, our external partners, and other Daiichi Sankyo Group companies, keeping “small at heart” in mind.

President

Yasunori Tawaragi, Ph.D.

ASB-US Asubio Pharmaceuticals, Inc.

Daiichi Sankyo Pharma Development Plexxikon Inc.

A

Fantasy, Passion and Vocation are

my favorite keywords for drugdevelopment.

“

”


DSPDMessage from the Top

PLX

Developing Novel Medicines for Unmet Needs to Improve Patients’ Lives Is Plexxikon’s Highest Priority

t Plexxikon, we have brought together highly trained experts from diverse scientific disciplines to form a cohesive and highly motivated team with the desire to pioneer the field of personal-

ized medicines. Key to building this organization was the successful inte-gration of all functions, so that handovers for project transitions are seam-less. This also requires team members to stretch their responsibilities beyond their functional and core job expertise. Scientific rigor is applied daily to every project. The team shares a sense of urgency in that losing time should be prevented at almost any cost. None-theless, we recognize that technologies continue to advance and that we must continue to challenge ourselves to incorporate the best practices for our various drug discovery and development projects. For any new project undertaken at Plexxikon, we select targets that are amenable to co-crystallography and structure analysis at the lead discov-ery and optimization phase. We focus on target-rich protein families en-

abling us to leverage our investment in chemistry. We develop biomarkers to help us understand critical PK/PD relationships and attempt to translate this from the preclinical to the clinical setting. We also seek to develop biomarkers as potential diagnostic tools, in order to identify those patients with the highest probability of deriving benefit from the new drug treatment. Currently, Plexxikon has 45 employees, giving us the capacity to bring one new chemical entity (NCE) into the clinic annually on average. While a number of our programs address unmet needs in oncology, we are concurrently developing projects in other therapeutic indications (such as neuroinflammation) if they follow the above paradigm.

A

Innovative ‘First-in-Class’ Translational Research Approaches

Plexxikon’s R&D in Drug Discovery Efforts

ith training in Pharmacology at Yale and UCSF, I experienced the explosion in revolu-tionary discoveries made possible through the

technological advances of modern times. I came with great excitement to Plexxikon, at first helping build an infra-structure using these latest advances for drug discovery of new targets. But I learned that new targets come with un-knowns in biology and medicine, requiring innovative re-search approaches for success. As the head of Translational Pharmacology, I now oversee preclinical research from leading academic groups numbering a few hundred, allow-ing drug testing in the most-informative disease models. Along the way, my group nimbly sleuths for new biomark-ers, both to monitor drug responses, and actually to helpunderstand the new target and associated diseases. Impor-tantly, we also work with the clinical teams to introduce these biomarker tests into our drug trials.

lexxikon is aspiring to develop novel therapeutic concepts, such as targeted and personal-ized medicines. Zelboraf® is an excellent example for this approach of matching the treat-ment to the underlying disease mechanism. Other Plexxikon projects follow the same ratio-

nale. For example, with PLX3397, we are targeting the tumor microenvironment, especially infil-trating macrophages and mast cells. Because this disease mechanism does not directly target the tumor cell, the development of a diagnostic test is more challenging. Nonetheless, Plexxikon is collecting data on several biomarkers and, following a retrospective analysis, will decide how to move an appropriate test into development as a diagnostic. In parallel, Plexxikon is also exploring new imaging approaches to visualize inflammatory infiltrates, since biopsies are frequently very difficult to obtain. We expect that PLX3397 will most likely be used in combination with other drugs and/or radiation therapy, and, thus, such studies are either in pilot or planning stages. PLX5622 very selectively targets the macrophages in the periphery and microglia in the brain. While initial development was focused on peripheral autoimmune/inflammatory diseases, we are now also exploring neuro-inflammation indications to capitalize on the drug effects on activated microglia in the brain. As such, PLX5622 could represent a first-in-class opportunity in several areas of significant unmet medical needs.

Plexxikon was founded in 2000 and after complet-ing its Series A financing, began operations in Berkeley in 2001. Initially, the infrastructure was built to support an industrial-scale protein crys-tallography platform. After-establishing initial proof of concept for the platform, earnest drug dis-covery started in 2003 leading to the first IND and FIH in 2004 for a PPAR pan-agonist for the treat-ment of diabetes. This required building the infra-structure for early clinical development at Plexxikon. The next major inflection point was Plexxikon’s IND filing of PLX4032 (vemurafenib, Zelboraf®) in 2006 and a subsequent collaboration with Roche to co-develop this drug. PLX3397, a highly selective dual inhibitor of Fms and Kit, is currently being tested in several signal-seeking studies for selected cancers. PLX5622, a selective Fms inhibitor, is at the Phase 1 multiple dosing stage, and we are evaluating its potential for either rheumatoid arthritis or a neuro-inflammation indi-cation.

Founder & CEO

Peter Hirth, Ph.D.

Director, Translational Pharmacology

Brian West, Ph.D.

Plexxikon’s Initiatives for First-in-Class Discovery

Overview of PLX

P W

Our success hinges on quality, clinicalexcellence and

developing innovative medicines that offer

patients greater clinical benefit over existing

therapies.

“

”

DSPD is Dedicated to DeliveringInnovative Medicines to Patients

aiichi Sankyo Pharma Development is the delivery arm for the Americas Region, one of four regions in the Global Research & Development Organization. Our mission is to lead and

contribute to global drug development projects and deliver innovative medicines to patients with unmet medical needs. We have a talented and diverse team of over 300 scientists and support staff based in Edison, New Jersey, working in Oncology, Cardiovascular, Metabolism, and Frontier therapeutic areas, dedicated to progressing medicines from First in Human to registration. We work closely with our Medical Affairs and commercial colleagues to provide necessary clinical and medical support as well as evaluation of licensing opportunities.

In today’s pharmaceutical industry, we are constantly challenged by many external pressures, such as complex, non-harmonized regulatory requirements, pricing and reimbursement pressures and public perception. While we must understand these pressures and work to address them,

DSPD keeps focused on our guiding principle that Patient Safety Comes First. Everything we do and every goal we work toward must always have the patients’ best interest in mind.

D Location Edison, NJ

Number of Employees Approx. 300

Overview of DSPD

Executive Vice President,Head of Drug Development - Americas Region

Mahmoud Ghazzi, MD, Ph.D.

Edison Office



R&D


ADME/Tox studies● Collaboration between DMPKRL and TCRM on

ADME/Tox studies using fresh human tissues will remain important.

● We expect TCRM to contribute to the DS R&D mission by maintaining a good relationship with DMPKRL and by producing high-quality and stable data continuously.

Drug target research● To acquire novel information, know-how, tech-

nology, and experience about drug target research to expand function and activity.

● To build up a tight bond with departments other than DMPKRL like MSRL, CV-M, FRL, BRL, Bio-logics, and research organizations like Asubio or U3 Pharma.

● To provide these collaboration partners not only technology and data but also innovative information and/or ideas.

FoundationLocationNumber of Employees

1998Munich, GermanyApprox. 15

Overview of TCRM

Research Department in Martinsried Assumed Additional Tasks

he Daiichi Sankyo Tissue and Cell Research Center Munich (TCRM, formerly ‘Drug Metabolism’) has expanded its field of ac-tivity and has recently started to work for the central research facili-

ties in Japan as well. Founded in 1998, the department’s main responsibility used to be researching the human tolerance of new pharmaceuticals. Today, TCRM also participates in finding new therapeutic approaches. The newly created areas ‘ADME/Tox’ and ‘Drug Target Research’ are supposed to in-tensify existing projects in the upcoming years while, at the same time, open-ing up new cooperation possibilities with other Daiichi Sankyo research de-partments and research organizations within the DS Group. For this reason, the TCRM offices headed by Jürgen Müller, and his team managers Ve-ronika Rozehnal and Thomas Fischer moved to a new building providing 1,000 square meters of office and laboratory space in the Munich suburb Martinsried. The team celebrated the official opening in February 2012. Müller says: “The company headquarters understands that we possess first-class scientific know-how here in Martinsried. This is why the Daiichi Sankyo management has made the decision to expand our field of activity. To us, this is a confirmation of the quality of our work and the importance of Munich-Martinsried as a location”.

Vice President

Dr. Jürgen Müller

TCRM Daiichi Sankyo Tissue and Cell Research Center Munich

T


Roles and Responsibilities:At DSD/DSID, we are accountable for the regional delivery and resourcing of global clinical trials to meet Daiichi Sankyo’s overall vision. We contribute to the design and reporting of global clinical trials, and manage the efficient and timely execution of those trials across Europe and India. We prepare and submit product applications to local health authorities. DSD/DSID either leads or is an active participant in global development programs as well as many initiatives that are ongoing, such as CLINTEX. 　Over the last two years, we have also established a very productive and effective collaboration with the European Commercial Division (Daiichi Sankyo Europe GmbH). And with the Regulatory Affairs and Biostatistics & Data Management Organisation (BDO) in Munich reporting functionally through DSD UK, we have the opportunity to work seamlessly across the entire value chain from phase I to marketed products.

Partner in Global Product Development

ur mission is to be a partner in global development strategy, deliv-ering innovative products to market through operational effi-ciency.

Our current key priorities are to:

● Globally align DSD’s operational plans to contribute to the optimized re-gional resource utilization and talent development.

● Implement talent and leadership development to support employees so that they develop capabilities and achieve the full potential to meet our business needs and confidently influence and handle change.

● Successfully implement CLINTEX (Clinical Trial Excellence), so that we are in an optimal position for completion of the key late phase devel-opment and submission tasks ahead of us over the next year or so.

General Manager & Head, EU & India Drug Development

Dr. Sabine Bernotat-Danielowski

DSD Daiichi Sankyo Development Limited

O

Message from the TopDSD, Gerrards Cross, UK:Clinical Development, Clinical Safety & Pharmacovigilance, Study Manage-ment, Regulatory Affairs, Project

Management, Biostatistics & Data Management and Trans-lation Medicine & Clinical Pharmacology, Administration, Finance, Human Resources, IT, Informatics, Outsourcing, Contracts Management and Document Management.

Daiichi Sankyo Europe GmbH, Munich, Germany (DSE):Regulatory Affairs, Biostatistics & Data Management functionally report in to DSD.

Daiichi Sankyo India Pharma Pvt Ltd (DSIN):Clinical Development, Bioanalytics, Medical Writing, Study Management, Quality Assurance, and Regulatory Affairs at DSID Gurgaon – the development organization in India – functionally report in to DSD. Refer also to the DSIN article in this edition of .

History:Legacy Daiichi Pharmaceuticals Ltd was established in London, U.K. in April 1993. Following the merger, the offices subsequently relocated from London to Gerrards Cross in January 2007, which we share with the U.K. Com-mercial Division DSUK.

Permanent Employees:The permanent head count within the DSD/DSID organiza-tion is currently 85 excluding open positions (DSD UK, 58, DSD Munich, 21, and DSID, 6)

Overview of DSD

U3 U3 Pharma GmbH

Discover First-in-Class Drugs against Cancerhe ultimate objective of U3 Pharma is to discover and develop new and innovative biological drugs with high thera-peutic benefit for patients of cancer disease. Two of our current projects, U3-1287 and U3-1565, are already in the clinical phase, and are expected to be the first U3-origin products reaching the market. We collaborate with various functions of Daiichi Sankyo (DS) under DS

global development management to develop these two and the coming projects. We aggressively work to discover next candidates for development in research. U3 Pharma keeps complete freedom to oper-ate research programs until a certain stage in preclinical research, which enables us to quick decision making and high risk taking. We believe this is one of the advantages of U3 as a small biotech company. A deep understanding of target biology is critical particularly in the development of a first-in-class drug. However, in order to win the race towards highly efficient first-in-class cancer drugs, research on target biology and evaluation of drug candidates needs to be done in parallel. Our experience in translating target biology into drug discovery will allow us to develop more inno-vative drugs in the future. Our challenge is to accelerate this development process for the first-in-class drugs in oncology together with DS’s colleagues. U3 Pharma will discover and develop more first-in-class drugs and will contribute to the progress of cancer therapy and to the business success of the DS Group.

U3 First-in-Class Therapeutic Antibodies in Clinical Stage

s there any sense in developing an antibody against a catalytically impaired tyrosine kinase?” Ten years ago, this was the standard

remark of people who were presented the U3-1287 program for the development of anti-HER3 anti-bodies. It was the deep expertise, undeviating gut feeling, and continuous support of Axel Ullrich who originated the HER3 program, U3 Pharma col-leagues’ passion and fascination to meet new chal-lenges, and the courage to take risks that moved this program forward despite of general skepticism. Today, the important role of HER3 in tumorigenesis is broadly recognized, and the U3-1287 project has been taken to clinical phase 2 by a global team of passionate scientists. Promising results here as well as for the U3-1565 anti-HB-EGF antibody program— U3’s second first-in-class project in clinical stage— are the exciting return of combined efforts. Just as the verification that there is a lot of sense in devel-oping an antibody against a catalytically impaired tyrosine kinase!

Challenge and Opportunity of First-in-Class Drugs

rug discovery of first-in-class cancer therapeutics is a highly demanding and risky business. The complexity arises

from identifying a new target, validating the target mechanism for the disease, and generating and de-veloping an effective target-specific compound. In addition, deep understanding of tumor biology and tumor-specific gene and protein expression profiles are required for successful targeted therapy. Despite these challenges, the last decades in science and drug discovery showed that there is potential to offer real benefits for cancer patients. My personal passion and enthusiasm for early drug discovery started in Axel Ullrich’s department when I was trained in molecular biology. Since he has been part of the development process for many innovative drugs, his team was encouraged to identify and un-derstand new targets for cancer therapy. With that spirit, I believe that our constant and concerted ef-forts in this field may lead to major improvement and hope for cancer patients.

3 Pharma is leveraging its science-level strengths with respect to highly variable targets, and it has already brought two drug

development projects to clinical trial stages since its establishment. U3 Pharma collaborates with academic institutions such as, for example, the Max Planck Institute of Biochemistry, to expand its research capa-bilities. The company takes pride in its powerful capa-bilities for highly creative research.

We concentrate on novel antibody drugs in oncology.• Internal works are concentrated on discovery research. We actively collaborate » with academia and biotechs for novel knowledge,

ideas, and technologies, » with research laboratories of Daiichi Sankyo R&D

and contract research organizations for discovery programs, and

» with global project teams of Daiichi Sankyo for development projects.

• We prepare to access quickly next-generation bio-logics technologies for human antibody drugs.

U3 Pharma’s Current Pipeline• U3-1287 (Anti-Her3 antibody) » Phase 1b/2 study under way• U3-1565 (Anti-HB-EGF antibody) » Phase 1 study under way

Established in 2001, U3 Pharma was given its name to reflect its identity as the third company to be co-founded by Dr. Axel Ull-rich, who has earned worldwide acclaim for his pioneering work related to Herceptin and Sutent, is now serving as the Director of the Max Planck Institute for Biochemis-try. Currently employing 38 staff members, including 15 PhDs, U3 Pharma specializes in research related to antibody drugs in the field of oncology in line with its mission—“to discover and develop innovative thera-peutics in oncology for patients.”

Overview of U3

U3 Pharma is situated in a suburb of Munich that is a center of numerous biotech companies engaged in inde-pendent leading-edge research.

Jens Ruhe, Ph.D.Director

Esther Zwick-Wallasch, Ph.D.Director

U3 Pharma’s Activities

Cha

nge

in S

LD (

%)

0

-10

-20

-306SCR 10

Weeks on Study18 26

T

I D“

Measurable Tumor Shrinkage by U3-1287 Administration

U

CEO

Shoji Hirashima

We believe that U3 Pharma can contribute to DS business by pro-viding new drugs continuously to the product pipeline. We strive to be a more-efficient organization to discover first-in-class drugs in the oncology area.

CSO

Johannes Bange

We are excited and confident in the significant progress the company and our projects have made since the acquisition in 2008. Close collaboration with our colleagues in the global DS

organization is one of the success factors.



R&D

TCRM will play a major role within the global research of Daiichi

Sankyo. This location also contributes to the global research and

development.

“

”


RCI

Research with Emphasis on Microbiology and Inflammation

aiichi Sankyo Life Science Research Institute in India (RCI) has been in existence for more than two years. We are an early-discovery research organization with the responsibility to iden-

tify good-quality RD-3 candidates for clinical development. Our research has been centered upon two therapeutic areas: microbiology and inflam-mation. We have focused on the discovery of novel antibiotics and treat-ments for lung diseases, such as COPD and asthma. We have been reason-ably successful in our endeavors and have identified one RD-3 candidate for COPD and plan to propose an antibacterial RD-3 candidate soon. The initial RCI research programs were originated from the ongoing programs in Daiichi Sankyo Tokyo. Now, we are commencing an endog-enous research portfolio which will result in high-quality clinical candi-dates. To achieve this goal, we must identify and access “state of the art” research globally and so, in addition to ongoing successful collaborations with Daiichi Sankyo research teams, we are looking to collaborate with leading academic research laboratories. I am confident that the RCI research team will rise to the occasion. The RCI mission is to become an efficient Indian drug discovery-development unit of Daiichi Sankyo that has the ability to Reinforce Continuous Innovation.

Joint Collaboration with DS, RCI, and Ranbaxy

Roles and Responsibilities:

ur mission is to enhance global development execution effi-ciency by consistently delivering projects across phases in key therapeutic areas through a fully outsourced model for

the DS global pipeline so as to deliver the India Advantage. Our current key priorities are to: 1. Globally align DSID’s operational plans to contribute to the optimized regional resource utilization

and talent development 2. Collaborate with RCI and support compound development optimizing utilization of common geo-

graphical location 3. Support collaboration with Ranbaxy in select areas (such as TMCP and BDO)

DSID reports to the DS- Development (DSD) organization and is functionally aligned to DSD and DSPD. At DSID, we are ac-countable for the regional delivery and resourcing of global clinical trials to meet Daiichi Sankyo’s overall vision. We con-tribute to the design and reporting of global clinical trials, and manage the efficient and timely execution of those trials across India. DSID is an active participant in global development programs as well as many initiatives that are ongoing, such as CLINTEX. We also contribute to bioanalysis and medical writing activities from DSID. DSID is part of key global development projects, such as edoxaban, CS7017, and has successfully completed the Welchol DDI studies in the past.

RCI is a research-based drug discovery group. RCI is a part of Daiichi Sankyo India Pharma Pvt. Ltd. (DSIN), which is a wholly owned subsidiary of Dai-ichi Sankyo Co. Ltd.. With the strength of more than 160 scientists, RCI focus is in small molecule drug discovery research in the areas of infectious and inflammatory diseases. RCI is equipped with state-of-the-art laboratories for design, synthe-sis, and evaluation of new chemical entities in in vitro and in vivo experimental setups for biological activity and drug-like characteristics. RCI research is focused on the discovery of novel anti-biotics and treatments for lung diseases, such as COPD and asthma.

Clinical Development, Bioanalysis, Medical Writ-ing, Clinical Operations, Quality Assurance, and Regulatory.

History:DSID was established in Mumbai, India in 2008. The offices subsequently relocated from Mumbai to Gurgaon in December 2010 to co-locate with RCI and the Operations and Management team.

Permanent Employees:The permanent head count within the DSID organi-zation is currently 6, excluding open positions, which are 5.

President & Head

Dr. Pradip K Bhatnagar

Director & Lead (Interim)

Dr. Seema Pai

Overview of RCI

Overview of DSID

DSID

Daiichi Sankyo Life Science Research Center in India

Daiichi Sankyo India Development

D

O

R&D



Topicsfrom theW rld

Global

TRILOGY ACS Results Regarding PrasugrelWere Announced

On August 26, the ESC congress started with a major and eagerly awaited data an-nouncement: The results of the TRILO-

GY study, which compares prasugrel plus aspirin to clopidogrel plus aspirin in patients with unstable angina (UA) or non-ST elevation myocardial in-farction (NSTEMI) who were managed medically without an artery-opening procedure. The study did not meet the primary objective of demonstrat-ing prasugrel’s superiority over clopidogrel in this patient population. From a safety perspective, TRILOGY ACS showed that rates of TIMI major bleeding events (including life-threatening or fatal bleedings) did not differ significantly between the prasugrel plus aspirin and clopidogrel plus aspirin treatment groups in patients less than 75 years of age or in the overall study population. “While the study did not demonstrate prasugrel was superior to clopidogrel in these patients, TRILOGY ACS provided some additional observations in this pre-viously understudied population. The delayed treatment effect beyond 12 months observed in TRILOGY ACS had not been seen in earlier stud-ies of shorter duration”, explained E. Magnus Ohman, M.D., Duke Clinical Research Institute and Chairperson of the TRILOGY ACS trial. A post-hoc exploratory analysis observed a trend for a lower risk in heart attack, stroke, and death among patients treated with prasugrel beyond one year.

The results were presented in a “hot line session” by primary investigator Dr. Matthew Roe of Duke Clinical Research Institute at 11:00 am to physi-

cians from all over the world. TRILO-GY ACS was a multi-center, double-blind, randomized, con-trolled trial to evalu-ate the safety and ef-ficacy of prasugrel plus aspirin com-pared to clopidogrel plus aspirin in UA/N-STEMI pa-tients who were to be medically managed without revascular-ization. The primary end point was the time to occurrence of

the first instance of the composite end point of car-diovascular death, heart attack, or stroke. The pri-mary data manuscript has been accepted for simul-taneous publication in the New England Journal of Medicine.

“I would like to take this opportunity to extend my personal thanks to everyone at Daiichi Sankyo who contributed to the conduct and completion of TRILOGY ACS. For Daiichi Sankyo, I believe TRILOGY ACS continues us along our path to be-coming a Global Pharma Innovator, particularly in the cardiovascular field in that we conducted a large-scale, well-designed global clinical trial. I en-courage us all to maintain our focus on achieving current and future goals for Effient®/Efient®, as well as for healthcare professionals and ACS patients around the world,” said Joji Nakayama, Represen-tative Director and CEO of Daiichi Sankyo.

Global Patio 2012 vol. 20 Global Patio 2012 vol. 2018 19

Topicsfrom theW rld

From

China

From

Japan

Global

From

Malaysia

Antibacterial agents are one of the most widely used drugs in clinical. They can cure and save many lives of patients;

meanwhile, there have been adverse consequences caused by the unreasonable application of antibac-terial agents, such as the increase in adverse reac-tions, the growth of bacterial drug resistance, and the failure of treatment, which have sometimes had a significant impact on patients’ health and some-times even cost a patient his life. Therefore, to pro-mote the rational use of antibacterial agents and effective control of bacterial drug resistance and ensure the quality and safety of medical care, the Ministry of Health in China has implemented spe-cial rectification activities of national clinical use

“China-Japan Hospital Infection Management SummitForum 2012” Has Achieved a Complete Success

of antibacterial agents since 2011.The China-Japan Hospital Infection Manage-

ment Summit Forum 2012 convened at the Univer-sity of the Ryukyus School of Medicine on May 17, 2012 on the occasion of “Special rectification ac-tivities of national clinical use of antibacterial agents” that will be carried out for one year, and DSCN employees joined it. During this forum, Chinese and Japanese experts shared their respec-tive hospital infection management expertise and experience and made exchanges on how to improve the current difficulties and problems. The meeting also embodied how Daiichi Sankyo fulfills its so-cial responsibilities actively.

Daiichi Sankyo, Co. Ltd. (Daiichi Sankyo) and Coherus BioSciences, Inc (Coherus BioSciences) announced the execution of

an exclusive agreement to develop and commercial-ize biosimilar forms of etanercept and rituximab in certain Asian countries, including Japan.

Under the terms of the agreement, Daiichi San-kyo and Coherus BioSciences will work together to develop, manufacture, and commercialize biosimi-lar forms of etanercept and rituximab developed by Coherus BioSciences. Upon marketing approval, Daiichi Sankyo will commercialize these products in Japan, South Korea, and Taiwan. Coherus has retained all additional development and commer-

The video program ‘The Story of Jokichi Takamine’ is posted on the Daiichi San-kyo corporate web site. It commemorates

the 100th anniversary of the planting of cherry trees in Washington, D.C. against the backdrop of the 2012 National Cherry Blossom Festival (NCBF).

The video program introduces NCBF as well as the life of his and the person who played a pivotal role in getting the cherry trees to Washington, D.C.

Dr. Takamine was the first president of Sankyo Co., Ltd. and a world renowned chemist as well as a “goodwill ambassador”, and the video program looks back over the trials and tribulations of his ca-reer and his various achievements, such as the dis-

cial rights outside of the licensed territories. Spe-cific financial terms of the agreement were not dis-closed.

“Coherus BioSciences has established an out-standing business model, a very experienced bio-logic development team and outstanding capabili-ties,” said Joji Nakayama, President & CEO of Dai-ichi Sankyo. “By creating an opportunity for an early entry into the biosimilars market, this agree-ment will strengthen our internal platform for manufacturing and developing biopharmaceuti-cals, leading directly to the introduction of other biosimilars’ therapies in the future.”

coveries of “Taka-diastase,” a digestive enzyme, and the hormone adrenaline.

Establish Strategic Collaboration to Developand Commercialize Biosimilar Candidates

Enjoy Dr. Jokichi Takamine Video Program

Celebrating 30 Years in Malaysia

Ranbaxy Malaysia Sdn Bhd (RMSB) re-cently celebrated 30 years of successful operations in Malaysia. RMSB has been

one of the first joint ventures of Ranbaxy. It is today one of the major generic companies in Ma-laysia providing medicines in the Cardiovascular, CNS, Anti-infective, Gastroenterology and Anti-viral therapeutic segments.

RMSB has been a leader in branded generic prod-ucts in Malaysia since 1996. On several occasions, Ranbaxy Malaysia was the first to launch generic versions of blockbuster molecules. Earlier in the year Ranbaxy Malaysia was adjudged the Malaysian Pharmaceutical Company of the Year in the Gener-ics Drug Category by Frost & Sullivan, which is a matter of great honour. They are backed by an excel-lent sales force that is acknowledged for its innova-tive marketing strategies and professional approach. Ranbaxy Malaysia is now looking to expand the therapeutic basket by entering into new areas like Biosimilars, Oncology, CNS and Dermatology.

In December 2011, Ranbaxy and Daiichi Sankyo got into a synergistic initiative to market innovative products originally discovered by Daiichi Sankyo. As part of this arrangement, in the year 2012, RMSB has already begun to promote Cravit (levo-floxacin) Tablets and Injection in Malaysia.

To commemorate 30 years Ranbaxy Malaysia or-ganized two special events at Sg Petani and Kuala Lumpur on 27th and 28th August respectively. The enthusiasm and spirit of the 300 strong workforce was clearly visible at these events that were recently organised at Sg Petani and Kuala Lumpur.

The event at the Sg Petani plant was made memo-rable by the presence of Dr Tsutomu Une, Chair-man, Ranbaxy Laboratories Limited, Mr Arun Sawhney , CEO & MD, Ranbaxy, Mr Rajiv Gulati, President, Global Pharmaceuticals Business, Ran-baxy, Mr Sanjeev I Dani, Executive Vice President Regional Director, Asia Pacific, Eastern EU, Ran-baxy and Mr Sandeep Girotra, Sr Vice President and Global Head – HR, Ranbaxy. The 30 years cel-

ebration event was preceded by the inauguration of the Quality and General Block (Packaging) by Dr. Tsutomu Une and Mr Arun Sawhney .

The celebratory event which followed the inau-guration, was graced by State Executive Councillor of Kedah, Dato’ Hj Aminurdin and attended by staff, customers and vendors.

On 28th August, a similar event was held at Shan-gri La Hotel, Kuala Lumpur to commemorate 30 years. The event was graced by H.E. Mr Shigeru Na-kamura, Ambassador of Japan to Malaysia and Mr Aseem R Mahajan, Deputy High Commissioner to Malaysia, Indian High Commission. In this event all the eminent partners who have been a partners in this success story were acknowledged for their valu-able contribution and were also presented with awards.

To further cap the growing potential, the pro-posed new investment in a Greenfield manufactur-ing facility has been approved and accorded Entry Point Project commonly known as EPP under the Government Economic Transformational Project. This will be Ranbaxy’s second manufacturing facil-ity in Malaysia, which will serve the local market and also export products to markets like ASEAN, Middle East, Europe, Sri Lanka, Sri Lanka, China and other select countries.

It has been a great journey so far, once again con-gratulations to Team Malaysia and wishing them a bright future ahead.

Chairman : Prof. Wu Bin Guangdong Medical College

Click!


Topicsfrom theW rld

From

EU

From

EU

From

Venezuela

From

Mexico

From

Japan

Raise the Curtain for Daiichi Sankyo Europeat the ESC Congress 2012

Munich is the host for one of the most-im-portant global congresses dedicated to cardiovascular (CV) diseases this year: the

annual congress of the European Society of Cardi-ology (ESC) 2012 being hosted in Munich from Sat-urday, August 25 to Wednesday, August 29 2012. It is the largest medical meeting in Europe, gathering over 35,000 participants from all over the world every year – a huge, unique opportunity to show Daiichi Sankyo’s commitment in cardiovascular diseases.

With four symposia, four press briefings, several abstracts and posters covering latest developments in the fields of hypertension, atrial fibrillation, ve-nous thromboembolism and acute coronary syn-drome (ACS), Daiichi Sankyo was positioning it-self as a leader in cardiovascular therapy. A series of scientific contributions by Daiichi Sankyo and

Jan Van Ruymbeke, 53, became the new Chief Executive Officer of Daiichi Sankyo Europe. The native of Belgium replaced

Reinhard Bauer, who is retiring after 10 years in this position. Van Ruymbeke assumed responsibil-ity for the pharmaceutical company in October. Until the end of June, he had been the Executive Vice President at Grünenthal leading that compa-ny’s business in Latin America.

After studying medicine at the Catholic Univer-sity of Leuven, he worked for several years as a gen-eral practitioner and a medical advisor. He started his pharmaceutical career at Cilag Belgium before accepting a position with Janssen Pharmaceutica, where he directed the indication areas for infec-tious diseases and dermatology. In 1996, he became General Manager of Janssen-Cilag Hungary. Four years later, he assumed the position of Executive Director Pharma & Country President at Novartis South Africa.

In 2005, Van Ruymbeke joined Grünenthal, where he served as Head of Global Brand Manage-ment. Two years later, he was appointed Managing Director of the German pharmaceutical company’s Spanish subsidiary. He then became the Managing Director respon-sible for Spain and Portugal. In July 2010, he was named Executive Vice President of the Latin Ameri-ca strategic busi-ness unit. As part of these re-sponsibilities, he joined the Group Operating Com-mittee at the G r ü n e n t h a l Group.

on behalf of Daiichi Sankyo had the attention of the medical-scientific community and provides op-portunities to engage in discussions with custom-ers, colleagues, and competitors. Besides this, the Company presented itself for the first time under the new global corporate brand, which was reflect-ed in the entire exhibit and united the product brands under one umbrella outside the congress center with a total size of 196 square meters and on a d d i t i o n a l corporate ad-vertising cam-paigns featur-ing the new design.

Jan Van Ruymbeke to Become New CEOof Daiichi Sankyo EuropeThe Belgian Executive Replaces Reinhard Bauer in October

Daiichi Sankyo’s subsidiary Daiichi Sankyo Venezuela S.A. (Located: Caracas, Vene-zuela, hereafter, Daiichi Sankyo Venezu-

ela) will market products of Ranbaxy in Venezuela as part of the Hybrid Business Model. The Venezu-elan pharmaceutical market is the third largest in Latin America. Daiichi Sankyo had started its business in Venezuela prior to the other Japanese pharmaceutical companies and was able to build its presence with innovative pharmaceuticals, such as the hypertension medicine Benicar (olmesartan medoxomil).

Till now, Ranbaxy has been marketing the prod-ucts in Venezuela through a local distributor. Dai-

ichi Sankyo Venezuela will now take over this role. To kick off the new arrangement, Daiichi Sankyo Venezuela has already started the promotion of Ranbaxy products.

Daiichi Sankyo will now also focus on expand-ing Ranbaxy’s portfolio of medicines to promote the Hybrid Business Model, encompassing both in-novative and established pharmaceuticals to ex-pand and strengthen its presence in Venezuela.

Expand Hybrid Business in Venezuela

Daiichi Sankyo Mexico S.A. DE C.V. (DSMX) has launched the Daiichi Sankyo Group’s leading antihypertensive fran-

chise olmesartan medoxomil in Mexico under the name, Openvas®. It has also launched Openvas Co®, a combination preparation for use with a di-uretic. Openvas® and Openvas Co® are the first in-

novative pharmaceuticals marketed in Mexico by a Daiichi Sankyo Group company.

DSMX was established in 2011 to leverage the Group’s Hybrid Business Model in Mexico to offer both innovative pharmaceuticals and generics in Latin America’s second-largest market.

First Innovative Products Were Marketed in Mexico

We are excited about bringing Openvas® and Openvas Co® to patients in Mexico.

We are confident both medicines will en-hance our corporation more.

Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo have launched the se-lective DPP-4 inhibitor TENELIA® 20mg

tablets (generic name: Teneligliptin hydrobromide hydrate tablets) in Japan on September 10, 2012.

TENELIA® is a DPP-4 inhibitor created by Mi-tsubishi Tanabe and is the first drug of its kind to originate from Japan. TENELIA®, with its potent and sustained action, has made it highly effective in lowering each of the blood glucose postprandial levels, as well as fasting blood glucose levels, with once-a-day administration.

Mitsubishi Tanabe and Daiichi Sankyo, based on their strategic alliance to contribute to the treat-ment of diabetes in Japan, has begun joint market-ing the drug under one brand name: TENELIA® 20mg tablets. By providing this new treatment op-tion for type 2 diabetes mellitus (DM), Mitsubishi

Tanabe and Daiichi Sankyo aim to provide further support for patients combating this disease.

Launch of TENELIA®, A DPP-4 Inhibitor for Type 2 DM

PresidentDaiichi Sankyo Mexico S.A. DE C.V.

Toru Kirikoshi


Topicsfrom theW rld

From

U.S.

From

U.S.

From

U.S.

mitment to enhance our competitiveness within the U.S. pharmaceutical marketplace, diversify the Company’s U.S. capabilities, streamline opera-tions, minimize risks associated with product sup-ply, and gain greater control over the life cycle of products, from research and development through packaging and distribution.

After the tours, guests were treated to a Kagami-biraki ceremony. This is a traditional Japanese cer-emony during which the lid of a sake barrel is bro-ken open and the sake is served to all present. Ka-gami refers to the lid of the sake barrel and biraki means “to open” so kagami-biraki literally means

“opening the lid.” Because of the lid’s round shape, the kagami is a symbol of harmony. The kagami-biraki, therefore, represents an opening to harmo-ny and good fortune. Mr. Noriaki Ishida, Vice President, Corporate Communications of Daiichi Sankyo; Mr. Dieter Reuter, Sr. Vice President, Eu-ropean Supply Chain Management; Mike Dorn-hecker, Dr. Katsumi Fujimoto, Global Head of Pharmaceutical Technology; Mr. Allen Welsher, Sr. Vice President, Quality Assurance; and Dane-sha Dixon-Smith, Sr. Vice President, Human Re-sources donned happi coats and participated in the ceremony.

Nearly 130 people gathered at our packag-ing facility located in Bethlehem mid-July for the dedication ceremony. The packag-

ing facility gained FDA approval a month ago and augments our ability to package and distribute medicines to healthcare providers and ultimately to patients, particularly those who rely on our med-icines to treat cardiovascular conditions and dia-betes.

At the dedication ceremony, speakers including Jeff Lane; John Gargiulo; Mr. Joji Nakayama, our global Daiichi Sankyo President and CEO; Mike Dornhecker, and Pennsylvania Governor Tom Corbett remarked how the facility demonstrates our commitment to enhance our competitiveness within the U.S. pharmaceutical marketplace, di-versify our U.S. capabilities, streamline opera-tions, minimize risks associated with product sup-ply, and gain greater control over the life cycle of products. They also reiterated how we believe in helping to maintain and to enrich the local com-munity while also supplying jobs to skilled and

On July 12, President Joji Nakayama visited the Paramus, New Jersey, office of Asubio Pharmaceuticals, Inc., in the United

States. As this was his first visit to the new office since becoming president, Mr. Nakayama took the opportunity to explain to a group that included al-most all the office’s 26 staff about the Daiichi San-kyo Group’s expectations with respect to Asubio Pharmaceuticals’ operations and management.

“All of you at Asubio Pharmaceuticals have the important mission of implementing so-called POC studies in the United States and Europe for the compounds created in the course of Asubio drug discovery programs, which is a key step in prepara-tion for Daiichi Sankyo’s execution of large-scale

clinical trials, receipt of prod-uct marketing approvals, and launch of prod-ucts. While Asu-bio Pharmaceu-ticals’ 26-person workforce is a

dedicated workers from the region. Following the remarks, Mr. Nakayama; John

Gargiulo; Mr. Yuki Sato, Daiichi Sankyo’s Supply Chain Head in Japan; Jeff Lane; Mr. Frank Kne-feli, Daiichi Sankyo Europe’s Vice President Tech-nical Operations; and Mike Dornhecker planted ceremonial Japanese maple trees that symbolized the same spirit of friendship and cooperation that marked the planting of the cherry trees 100 years ago in Washington, D.C. The shovels used were wrapped in ribbons in the traditional Japanese red and white to symbolize an auspicious or happy oc-casion.

Following the tree planting, guests watched Mr. Sato, John Gargiulo, Mr. Nakayama, Governor Corbett, and Jeff Lane perform a Ribbon Cutting executed in traditional Japanese fashion, with the ribbon held in the left hand and the scissors in the right.

Guests then took a tour of the facilities to learn how from process and structure to quality systems controls and per-sonnel flow, the Bethlehem facility represents high-quality drug man-ufacturing and packaging for Daiichi Sankyo. The packaging fa-cility demon-strates our com-

r e l a t i v e l y small group, we are expect-ing increas-ingly great re-sults from your work in close cooper-ation with the Kobe head of-fice of Asubio Pharma Co., Ltd., and with other Daiichi Sankyo Group units.”

While responding to questions from Asubio Pharmaceuticals employees, Mr. Nakayama ex-plained the kind of organizational culture he is promoting. He expounded on his “small at heart” concept, which calls for people to strive to main-tain the perspective of people in small companies even though they may be members of large organi-zations, and he frankly praised the positive corpo-rate culture of Asubio Pharma, where he was previ-ously president when it was known as Daiichi Sun-tory Pharma.

Dedication Ceremony for Packaging Facilityin Bethlehem

President Nakayama Visits Asubio Pharmaceuticalsin the United States

Authorized Generic of Pioglitazone in the U.S. Launched

Ranbaxy Pharmaceuticals Inc., based in Jacksonville in the U.S., has launched au-thorized generic pioglitazone hydrochlo-

ride tablets in the U.S. market, under an agreement with Takeda Pharmaceuticals U.S.A., Inc.

Pioglitazone hydrochloride tablets are an oral antidiabetic agent that acts primarily by decreasing insulin resistance, presently distributed by Takeda Pharmaceuticals America, Inc. under the brand name Actos. The product is indicated for patients as an adjunct to diet and exercise to improve glyce-mic controls in adults with type 2 diabetes mellitus. Actos generated total annual sales of $2.7 billion in the U.S. (IMS – MAT June 2012).

Bill Winter, Vice President, Trade Sales and Dis-

tribution, North America, Ranbaxy said, “Ranb-axy is making available the full range of generic pioglitazone in 15mg, 30mg, and 45mg tablets. The introduction of generic pioglitazone hydrochloride tablets is a significant and important addition to our portfolio of antidiabetic products in the U.S. The launch further complements our resolve to bring high quality, afford-able generic medicines as early as possi-ble to the U.S. healthcare sys-tem.”Bethlehem Packaging Facility (Photo by David Fonda)

A Ribbon Cutting executed in traditional Japanese fashion (Photo by David Fonda)


Let’s examine the fiscal 2011 statements of income in detail.Interpreting the Consolidated Statements of Income

150

120

90

60

30

0

150

120

90

60

30

0

80

60

40

20

0

1,200

900

600

300

0

（JPY Bn）（JPY Bn）

（JPY Bn）（JPY Bn）

FY2010 FY2011

938.7

268.6

670.1

571.9

185.1

386.8

98.2

10.0

32.0

76.2

14.8

57.1

33.9

23.5

10.4

(JPY Bn)

Reflecting factors included provisions for potential losses relating to the settlement by Ranbaxy of claims by the U.S. Department of Justice(DOJ).

Besides the forex impact, net sales was impacted by the return of certain products that had been licensed-in and marketed in Japan to their licensors, and there was a large impact from a reduction in exports of levofloxacin that accompanied patent expiration overseas. Contributions from products newly marketed in Japan were not enough to totally offset those impacts.

Although there was a decrease in certain expenses owing to yen appreciation, increases were seen in such expenses as marketing-related expenses and the expenses of newly consolidated subsidiaries.

-28.7

-13.1

-15.6

8.3

-9.3

17.6

-23.9

-13.2

18.4

-55.5

2.0

32.9

-86.5

-26.8

-59.7

While appreciation of theIndian rupee led to valuation profits in fiscal 2010, the valuation losses caused by the depreciation of INR led to a significant decrease in ordinary income in fiscal 2011*.

Net sales

　Cost of sales

Gross profit

　SG&A expenses

　　 R&D expenses

　　 Other SG&A expenses

Operating income

　Nonoperating income

　Nonoperating expenses

Ordinary income

　Extraordinary income

　Extraordinary losses

Income taxes/Minority interests

Net income

150

120

90

60

30

0

(JPY Bn) (JPY Bn) (JPY Bn)

1,200

900

600

300

0

FY2010 FY2011 FY2012Forecast

150

120

90

60

30

0

80

60

40

20

0

Fiscal 2012 ForecastsWhat kind of performance are we forecasting for fiscal 2012? FY2012

41.3

28.4

12.9

11.1

7.9

3.2

1.8

23.8

39.6

We are expecting contributions from growth in sales of such products newly launched in Japan as Memary®/NEXIUM® and growth in the sales of Ranbaxy as well as a new contribution from the sales of Japan Vaccine Co., Ltd., which began operations in July 2012.

While aggressively investing in the development of edoxaban and prasugrel and other promising development projects, we will strive to restrain the overall level of costs and thereby boost profitability.

If forex rates continue to be in line with the forex rate assumptions we made at the start of the fiscal year, then there will not be additional impact on ordinary income from forex rate fluctuations. We do not anticipate the kind of extraordinary expense items that were seen in fiscal 2011.

YoYForecast

(JPY Bn)P o i n t s !

P o i n t s !

We announced our financial results in May 2012. The Senior Director of the Corporate Communication Department’s IR Group, Shigemichi Kondo, explains those results for us.

ShigemichiKondo

FY2010 FY2011

FY2010 FY2011

FY2010 FY2011

Income before incometaxes and minority interests

The value of the balance of Ranbaxy’s forex options (previously purchased to hedge forex risks associated with the conversion into Indian rupee of a growing volume of U.S.dollar income owing to Ranbaxy’s future expansion of its business scale in the United States) is recalculated based on current market prices at the end of each fiscal period. Since the previous fiscal period, the appreciation of Indian rupee against U.S.dollar causes a gain on valuation, while the depreciation of Indian rupee against U.S.dollar causes a loss on valuation.

*

The decrease in net sales and increase in SG&A expenses caused a decline.

Our Financial Pe rformance

Besides decreases in profit items down through ordinary income, the extraordinary loss just described caused a considerable decrease in net income.




(JPY Bn)

980.0

297.0

683.0

583.0

193.0

390.0

100.0

100.0

50.0

Net sales

　Cost of sales

Gross profit

SG&A expenses

　R&D expenses

　Other SG&A expenses

Operating income

Ordinary income

Net income

FY2011Results YoY

We are aiming for increases in revenue and profitability during fiscal 2012.

Financial Highlights

76.2

122.1 98.2

131.8 70.1

938.7

10.4

967.4

Fiscal 2011 Business Results/Fiscal 2012 Forecasts

Ordinary Income Net Income

Net Sales Operating Income

Ordinary Income Net IncomeNet Sales Operating Income

100.0122.1

98.2967.4 938.7 980.0

131.8

76.2100.0 50.0

70.1

10.4

Global Patio 2012 vol. 20Global Patio 2012 vol. 20 2726

EU (EUR Mn)

U.S. (USD Mn) Japan (JPY Bn)

FY2009 FY2010 FY2011 FY2012(Plan)

87.0

1,095100.0

94.4

77.2

353408

468 480

888

1,102 1,112

(JPY Bn) (USD Mn, EUR Mn)1,200

1,000

800

600

400

200

0

120

100

80

60

40

20

0

interview with dr. hager, page 11 (2012)

Healthcare

dsrdn daiichi sankyo

daiichi sankyogroups

daiichi sankyos strengths

groups rdfrom

innovative products

word patio

forecastsglobal patio

fields of innovative