Dr. Hager 2012 interview Daiichi Sankyo Co. Ltd.

Global Patio 2012 vol .20
COMPANY 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

Leveraging
First-Rate
Capabilities and
Businesses to
Fully Develop
Group-Wide
Synergies
Joji Nakayama
Representative Director,
President and CEO
CEO’s WILL
Special Interview
vol. 20
I n d e x
03 CEO’s WILL
Global Patio
Leveraging First-Rate Capabilities
and Businesses to Fully Develop
Group-Wide Synergies
Daiichi Sankyo R&D
Leveraging World-Class Skills
to 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
07
Overview of Initiatives to Strengthen the Group’s R&D
From Each R&D Base
19 Topics from the World
26
Global 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
The Belgian Executive Replaces Reinhard Bauer in October
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
Our Financial Performance
Fiscal 2011 Business Results/Fiscal 2012 Forecasts
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Special Interview
30 Corporate Slogan
02 Global Patio 2012 vol. 20 Global Patio 2012 vol. 20 03

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-tion,
our March 2011 acquisition 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
Q

Broad-Minded Specialists,
Dynamically Keeping in
Step with the Accelerating
Pace of Change
CEO's WILL
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 Ishida
Corporate Officer and Vice President,
Corporate Communications Department
Daiichi Sankyo R&D
Daiichi Sankyo Tissue and Cell Research Center Munich
Daiichi Sankyo Development Limited
Daiichi Sankyo India Pharma Private Limited
Daiichi Sankyo Life Science Research Center in India
Daiichi Sankyo India Development
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.
Major R&D Base

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.
R&D
Glenn Gormley,
MD, Ph.D.
Global Head of R&D
Senior Executive Officer
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

Organization Chart of DS R&D Division
R&D Division
R&D Planning Department
Global Project Management Department
R&D Administration and Support Department
Research Oversight Function
Biologics 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 Department
Japan Development
Oversight Function
Clinical Development Department I
Clinical Development Department II
Clinical Data & Biostatistics Department
New Drug Regulatory Affairs Department
Asia Development Department
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.
Dr. Taro Tokui
Vice President
of the Translational Medicine &
Clinical Pharmacology（ TMCP）Department,
R&D Division
Dr. Martin H.
Hager
Group 2,
Oncology Research Laboratories,
R&D Division
DS R&D Division
Priority Areas in Terms of R&D Stages
Late-stage
development
Life-cycle management
and markets
Early-stage
Research development
• Hypertension
• Bacterial infections
• Hyperlipidemia
• Thrombotic disorders
Discovery
Priority Areas
• Oncology　　
• Cardiovascular metabolics
New Areas
Drug creation based on disease mechanisms,
developing products with new mechanisms of
action that address heavily unmet needs
Realize the Benefits of Personalized Medicine
Message from a Researcher
FROM EACH R&D BASE
R&D Activities Being Conducted in Japan
t 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.
An Oncology Expert Is Tackling the Challenges
of Developing Targeted Therapies
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
M
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
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 science
and medicine — it’s what
motivates me every day.
“
”
T
I
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

Message from the Top
Seiichi
Yokoyama
Overview of ASB
Number of Employees Approx. 200
History
1979 Foundation of Suntory Institute for
Biomedical Research
2002 Incorporation by a company split up from
Suntory Limited
2010 Reorganization as a new company and
commencement of business
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
The most-important
thing is to realize inno-vation
researchers’ freedom to
conceive and promote
new concepts.
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
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
based on
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.
ASB Asubio Pharma Co., Ltd.
“
”
A
Daiichi Sankyo RD Novare Co., Ltd.
Dr. Hideyuki
Haruyama
Foundation
Location
Number of Employees
Oct. 2006
Tokyo, Japan
Approx. 300
R&D
Overview
of DSRDN
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
DSRDN
Strengthening Technology Platforms
and Aiming to Be Irreplaceable
R&D Solution Providers
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.
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
We are confident that
we can enhance
DSRDN’s brand by
providing beneficial
solutions to technologi-cal
challenges associ-ated
the drug discovery.
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
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.
“
”
R

Mahmoud Ghazzi,
MD, Ph.D.
Overview of ASB-US
Location
Number of Employees
Paramus, NJ
26 (Sept. 1, 2012)
Daiichi Sankyo Pharma Development Plexxikon Inc.
D Location Edison, NJ
History
1999 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
Develop First-in-Class Drugs
to Meet Unmet Medical Needs
Overview of DSPD
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.
Yasunori
Tawaragi, Ph.D.
President
ASB-US Asubio Pharmaceuticals, Inc.
A
Fantasy, Passion and
Vocation are
my favorite key
words for drug
development.
“
”
DSPD
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
A
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
Peter Hirth,
Ph.D.
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.
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
R&D
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 help
understand 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
Brian West, Ph.D.
Director,
Translational Pharmacology
Plexxikon’s Initiatives for First-in-Class Discovery
Overview of PLX
P W
Our success hinges on
quality, clinical
excellence and
developing innovative
medicines that offer
patients greater clinical
benefit over existing
therapies.
“
”
DSPD is Dedicated to Delivering
Innovative 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.
Number of Employees Approx. 300
Executive Vice President,
Head of Drug Development - Americas Region
Edison Office

Overview of DSD
Overview of TCRM
Foundation
Location
Number of Employees
1998
Munich, Germany
Approx. 15
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.
DSD Daiichi Sankyo Development Limited
Dr. Sabine Bernotat-
Danielowski
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.
TCRM Daiichi Sankyo Tissue and Cell Research Center Munich
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”.
Dr. Jürgen Müller
Vice President
T
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
O
DSD, 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)
U3 U3 Pharma GmbH
Discover First-in-Class Drugs against Cancer
he 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.
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.
Shoji Hirashima
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.
Johannes Bange
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!
Overview of U3
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.
CEO
3 Pharma is leveraging its science-level
strengths with respect to highly variable
targets, and it has already brought two drug
U
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.”
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
Change in SLD (%)
0
-10
-20
-30
SCR 6 10
Weeks on Study
18 26
T
“I D
Measurable Tumor Shrinkage by U3-1287 Administration
CSO
TCRM will play a major
role within the global
research of Daiichi
Sankyo. This location
also contributes to the
global research and
development.
“
”

RCI
Daiichi Sankyo Life Science Research Center in India
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
Dr. Pradip K
Bhatnagar
President & Head
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
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
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.
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)
Roles and Responsibilities:
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.
Dr. Seema Pai
Director & Lead (Interim)
Overview of RCI
Overview of DSID
DSID
Daiichi Sankyo India Development
D
O
R&D
Topics
from theW rld
Global
TRILOGY ACS Results Regarding Prasugrel
Were Announced
O n 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. 18 20 Global Patio 2012 vol. 20 19

Topics
from theW rld
From
China
From
Japan
Global
From
Malaysia
“China-Japan Hospital Infection Management Summit
Forum 2012” Has Achieved a Complete Success
A ntibacterial 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
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.
D aiichi 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-
T he 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 Develop
and Commercialize Biosimilar Candidates
Enjoy Dr. Jokichi Takamine Video Program
Celebrating 30 Years in Malaysia
R anbaxy 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!

Topics
from theW rld
From
EU
From
EU
From
Japan
From
Mexico
From
Venezuela
Raise the Curtain for Daiichi Sankyo Europe
at 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 to Become New CEO
of Daiichi Sankyo Europe
The Belgian Executive Replaces Reinhard Bauer in October
J an 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.
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.
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.
Launch of TENELIA®, A DPP-4 Inhibitor for Type 2 DM
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.
First Innovative Products Were Marketed in Mexico
Expand Hybrid Business in Venezuela
D aiichi 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.
D aiichi 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.
We are excited about bringing Openvas®
and Openvas Co® to patients in Mexico.
We are confident both medicines will en-hance
our corporation more.
President
Daiichi Sankyo Mexico S.A. DE C.V.
Toru Kirikoshi

Topics
from 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.
A Ribbon Cutting executed in traditional Japanese fashion (Photo by David Fonda)
N early 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
O n 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 Facility
in Bethlehem
President Nakayama Visits Asubio Pharmaceuticals
in the United States
Authorized Generic of Pioglitazone in the U.S. Launched
R anbaxy 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-
Bethlehem Packaging Facility (Photo by David Fonda) tem.”

Our Financial Pe rformance
Interpreting the Consolidated Statements of Income
Let’s examine the fiscal 2011 statements of income in detail.
Fiscal 2011 Business Results/Fiscal 2012 Forecasts
Net Sales Operating Income
（JPY Bn）（JPY Bn）
150
120
90
60
30
0
150
120
90
60
30
0
80
60
40
20
0
1,200
900
600
300
0
938.7
FY2010 FY2011
（JPY Bn）（JPY Bn）
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)
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.
Reflecting factors included provisions for potential losses relating to the
settlement by Ranbaxy of claims by the U.S. Department of Justice(DOJ).
-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
Fiscal 2012 Forecasts
What kind of performance are we forecasting for fiscal 2012? FY2012
(JPY Bn) (JPY Bn) (JPY Bn)
1,200
150
120
90
60
30
0
900
600
300
0
FY2010 FY2011 FY2012
Forecast
150
120
90
60
30
0
80
60
40
20
0
(JPY Bn) Po i n t s !
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.
Forecast YoY
Po 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.
Shigemichi
Kondo
FY2010 FY2011
FY2010 FY2011
FY2010 FY2011
Income before income
taxes 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.
Besides decreases in profit items down through ordinary income, the
extraordinary loss just described caused a considerable decrease in net
income.
FY2010 FY2011 FY2012
Forecast
FY2010 FY2011 FY2012
Forecast
70.1
FY2010 FY2011 FY2012
Forecast
(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
FY2011
Results 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
10.4
967.4
Ordinary Income Net Income
Net Sales Operating Income Ordinary Income Net Income
100.0
122.1
98.2
967.4 938.7 980.0
131.8
76.2
100.0 50.0
10.4

U.S. (USD Mn) Japan (JPY Bn)
EU (EUR Mn)
(USD Mn, EUR Mn) (JPY Bn)
1,200
888
1,102 1,112
FY2009 FY2010 FY2011 FY2012
(Plan)
87.0
1,095
100.0
94.4
77.2
353
408
468 480
1,000
800
600
400
200
0
120
100
80
60
40
20
0

Dr. Hager 2012 interview Daiichi Sankyo Co. Ltd.

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