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02.07/藤沢薬品AR 2002 表紙C4-C1 Y M C B
FU
JISAW
A P
HA
RM
AC
EU
TIC
AL C
OM
PA
NY
LIM
ITED
AN
NU
AL R
EPO
RT
2002
ANNUAL
REPORT
2002
Printed on recycled paper in Japan
02.07/藤沢薬品AR 2002 表紙C2-C3 DIC19 B
Corporate MissionFujisawa is a research-driven pharmaceutical company active in the world’s major markets —
Japan, North America, Europe and Asia — with sales outside Japan accounting for around
forty-five percent of net sales. True to its corporate mission “Fujisawa contributes to
healthier, more prosperous lives around the world by exploring the frontiers of human
health and disease,” Fujisawa is firmly committed to innovative research to satisfy unmet
medical needs and contribute to the progress of medical care.
Fujisawa Pharmaceutical Company Limited and Consolidated Subsidiaries
Financial HighlightsYears ended March 31
Contents1 Message from the President4 Principal Business Data6 Worldwide Operations
7 Highlights of the Year8 Japan
10 North America12 Europe14 Asia15 Top Ten Ethical Pharmaceuticals by Sales16 Other Businesses
18 R&D Activities22 Environmental Protection24 Board of Directors / Members of Management Committee25 Review of the Year
25 Selected Financial Data26 Financial Review28 Business Review
50 Management and Corporate Auditors51 Corporate Directory53 Stock Information
Statements made in this annual report with respect to Fujisawa’s current plans, estimates, strategies and beliefs and other statements that arenot historical facts are forward-looking statements about the future performance of Fujisawa. These statements are based on management’scurrent assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties.Consequently, undue reliance should not be placed on these statements. Fujisawa cautions the reader that a number of important factorscould cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are notlimited to: (i) changes in general economic conditions in, and the Pharmaceutical Affairs Law and other laws and regulations relating to,Fujisawa’s markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Fujisawa to marketexisting and new products effectively, (v) Fujisawa’s ability to continue to research and develop products accepted by customers in highlycompetitive markets and (vi) infringements of Fujisawa’s intellectual property rights.
Stock Information
Fujisawa Pharmaceutical Company Limited
Founded:January 1894
Date of Incorporation:December 20, 1930
Paid-in Capital:¥38,588 million
Number of Shareholders:11,985
Issued and Outstanding Number of Shares:330,183,034
Independent Certified Public Accountants:PricewaterhouseCoopersNihon Seimei Imabashi Bldg.,7th Floor 3-1-7, Imabashi,Chuo-ku, Osaka 541-8582,Japan
Stock Exchange Listing:Tokyo, Osaka, Nagoya
Transfer Agent:UFJ Trust Bank Limited6-3, Fushimi-machi 3-chome, Chuo-ku, Osaka 541-8502
Major Shareholders:Nippon Life Insurance Co.The Chase Manhattan Bank, NA, London (SL Omnibus Account)Japan Trustee Services Bank, Ltd. (Trust Account)The Mitsubishi Trust & Banking Corporation (Trust Account)UFJ Bank Limited NIPPONKOA Insurance Company, Limited UFJ Trust Bank Limited (Trust Account A)UFJ Trust Bank Limited (Daido Life Insurance Co. Account)The Bank of Tokyo-Mitsubishi, Ltd.State Street Bank & Trust Co.
(As of March 31, 2002)
For InformationCorporate CommunicationsFujisawa Pharmaceutical Co., Ltd.� Osaka Head Office� Tokyo Head Office
http://www.fujisawa.co.jp(Fujisawa Pharmaceutical Co., Ltd.)
http://www.fujisawa.com(Fujisawa Healthcare, Inc.)
http://www.fujisawaeurope.com/(Fujisawa GmbH)
http://www.pmpinc.com/(PMP Fermentation Products, Inc.)
http://www.fujisawa.com.tw/(Fujisawa Taiwan Co., Ltd.)
53
Millions of yen Thousands of U.S. dollars*
2002 2001 2002 Change (%)
Net sales ......................................... ¥341,356 ¥297,517 $2,566,586 114.7Income before income taxes ............... 47,007 36,190 353,436 129.9Net income ..................................... 26,151 20,529 196,624 127.4Shareholders’ equity ......................... 317,870 278,581 2,390,000 114.1
Amounts per share (in yen and dollars):Net income
Basic ...................................... ¥ 80.07 ¥ 63.62 $ 0.60 125.9Diluted ................................... 78.14 61.76 0.59 126.5
Cash dividends ............................. 16.00 12.00 0.12 133.3
Total assets ..................................... ¥474,546 ¥462,325 $3,568,015 102.6Research and development expenses ... 57,093 52,016 429,271 109.8
* The U.S. dollar amounts in this report represent, for convenience only, translations of Japanese yen at the rate of ¥133=US$1.
1
I am very pleased to report that Fujisawa
achieved record revenue and profits for the
year ended March 2002. Net sales rose to
¥341,356 million (US$2,567 million), up
14.7% over the year before, to set a histori-
cal high for the third consecutive year.
Operating income and net income jumped
39.4% to ¥46,852 million (US$352 million),
and 27.4% to ¥26,151 million (US$197 mil-
lion), respectively. Both operating income
and net income surpassed the record highs
reported for the year ended March 2000.
Message from the President
Business expansion was fueled by sales of
the immunosuppressant Prograf ®, which
achieved 43% growth with ¥72.4 billion
(US$544 million) over the year earlier.
Prograf ® has been the key growth driver over
the past few years, and is expected to con-
tinue this role over the coming years. Sales
of Protopic ® for atopic dermatitis, another
tacrolimus product and first in the class of
topical immunomodulators, or TIMs, also
increased.
2
Our global business is growing in line
with our expectations. In particular, North
Amer ican business, represented by
Fujisawa Healthcare, Inc., showed strong
growth in local currency terms, with sales
rising to US$703 million for the term from
US$509 million for the year before. Its sales
are now projected to reach US$1 billion a
few years from now. In Europe, we success-
fully completed the reorganization of our
European operations in January 2002. We
now have sales and marketing operations in
key European countr ies under Fujisawa
GmbH. The largest operational unit is the
newly created Fujisawa Deutschland GmbH,
which markets a var iety of products in
German-speaking countries.
Japan also reported increases in sales thanks to
products recently launched. These products
are expected to help us achieve our target
share of 3% in the Japanese ethical pharma-
ceutical market as of March 2003.
Strengthening sales and promotional activities
here is another item on the agenda. Toward
this end, we reshaped our field organization
in April 2002, increasing the number of our
area sales offices to 99 from 71.
2000 2001 2002 2005
Progress under the VISION 2005Return on EquityNet SalesOverseas SalesJapanese SalesNet Income
0
100
200
300
400
(¥bn)9.5%
7.8%
8.8%
10%
Years to March 31
400
40
3
Our commitment to innovative research
remains unchanged. Investment in research
for the year ended March 2002 came to
¥57,093 million (US$429 million), equiva-
lent to 16.7% of net sales, up 9.8% over the
previous year. We intend to continuously
invest in research and development, includ-
ing genomic research. Clinical development
of in-house generated compounds is also
progressing steadily. We filed an NDA for
micafungin, an injectable antifungal agent, in
Japan in June 2001. In the US, we submitted
an NDA for micafungin in April 2002 fol-
lowed by the Canadian submission of June
2002. We plan to soon file an NDA in
Europe. Furthermore, we are actively seeking
opportunities for in-licensing and product
acquisition. During the term, we acquired
various compounds either in clinical devel-
opment or already marketed.
Believing that our management system must
be able to coordinate our global business
development efforts, Fujisawa has revised its
headquarters organization effective June
2001 to strengthen global headquarters func-
tions. The Global Corporate Strategic
Planning group, a newly established unit, is
now responsible for global corporate
strategic planning in the fields of R&D,
manufacturing, and sales and marketing. The
development division has been reorganized
to promote global development of Fujisawa
products in an efficient and speedy manner.
I am confident that Fujisawa will be able to
achieve the goals set out in the long-term
management policy VISION 2005. We are
now looking beyond the year 2005 to secure
sustainable growth. To this end, we are
devising measures to improve profitability,
which is essential for us to become
competitive in the global market and
achieve our ultimate goal of becoming a
global megaplayer.
Last not but least, we successfully made
a global offering of the Fujisawa shares pre-
viously held by our main banks in 2001. I
believe this success is attributable in large
part to our long-standing commitment to
maintaining good communications with the
financial community. From here on, too, we
will remain dedicated to the realization of
a mutually beneficial dialog with our
stakeholders.
Hatsuo Aoki, Ph. D.President and Chief Executive Officer
Principal Business Data
4
1998 1999 2000 2001 2002
(¥ bn)Net Sales
350
280
210
140
70
0
281.6 277.3 289.1 297.5
341.4
1998 1999 2000 2001 2002
(¥ bn)Total Assets
500
400
300
200
100
0
1998 1999 2000 2001 2002
(¥ bn)
50
40
30
20
10
0
15
12
9
6
3
0
7.9
12.0 12.1
11.3
Operating Income and Ratio to Net Sales
Operating Income Ratio to Net Sales(%)
13.7
1998 1999 2000 2001 2002
189.9
261.9
303.8
260.9
Current Ratio (%)
169.5
350
280
210
140
70
0
1998 1999 2000 2001 2002
(¥ bn)
–10
(1.5)
7.9
6.9
(0.5)
Ratio to Net Sales(%)
40
30
20
10
0
08
6
4
2
0
–2
Net Income (Loss) and Ratio to Net Sales
Net Income (Loss)
3.2
7.7
1998 1999 2000 2001 2002
–5
–10
(%)
15
10
5
0
Return on Equity
491.4
436.2 421.7
462.3 474.5
22.2
33.4 34.8 33.6
8.9
22.920.5
26.2
46.9
(0.7)
3.9
9.5 7.8 8.8
(Years ended March 31)
5
Pharmaceuticals 91.1%
Ethical Pharmaceutical 87.2%
Other Business 8.9%
Sales by Business Segment
See page 28
OTC Drugs 3.9%
Digestive system drugs2.2%
Anti-allergy drugs 4.8%
Sales of Ethical Pharmaceuticals byTherapeutic Category
Cardiovascular and respiratory drugs
16.2%
Nervous system and sensory organ drugs
13.9%
Metabolic drugs24.5%
Others 11.0%Antibiot ics and biologica l
preparat ions 27.4%
1998 1999 2000 2001 2002
(¥ bn)
60
48
36
24
12
0
Ratio to Net Sales(%)
30
24
18
12
6
0
R&D Expenses and Ratio to Net Sales
R&D Expenses
16.7
41.5
57.1
41.845.6
52.0
1998 1999 2000 2001 2002
(¥ bn)
25
20
15
10
5
0
Acquisition of Property, Plant and Equipment
14.7
17.5
19.8 19.7
24.4
1998 1999 2000 2001 2002
(¥ bn)
25
20
15
10
5
0
Depreciation and Amortization
13.914.9 15.6 16.1
20.4
19991998 2000 2001 2002
(¥ bn)
80
60
40
20
0
100
Total Sales of Tacrolimus(Prograf & Protopic )
51.9
81.2
42.2
33.3
21.7
® ®
Prograf Protopic ® ®
14.7 15.1 15.817.5
See page 29
Worldwide OperationsFounded in 1894, Fujisawa has steadily evolved
as a research-driven pharmaceutical company
and is active in the world’s major pharmaceuti-
cal markets — Japan, North America, Europe
and Asia.
The Company’s overseas operations, account-
ing for 44.1% of net sales for the year ended
March 2002, are growing significantly as sales
of its flagship product Prograf ® keep rising.
Protopic®, the first TIM in the world and the
second global product following Prograf ®, is now
making successful inroads into world markets.
6
Highlights of the Year
� Fujisawa achieved record revenue and profits —
net sales of ¥341,356 million (US$2,567 million),
operating income of ¥46,852 million, and net
income of ¥26,151 million (US$197 million).
� Fujisawa Healthcare, Inc. posted over US$700
million in sales thanks to robust growth in sales of
Prograf ®, Adenoscan®, and AmBisome® together with
the newly launched Protopic®.
� The European business of Fujisawa is now
streamlined under Fujisawa GmbH after the reorga-
nization was completed by the creation of Fujisawa
Deutschland GmbH in January 2002.
� Prograf ® achieved 43% growth with ¥72.4 bil-
lion, and is now marketed in 57 countries follow-
ing the latest launch in Romania in March 2002.
� Protopic ® is now moving to the stage of global
marketing. It is now available in Japan, the US,
Canada and some European countries including
Germany and the UK. Protopic ® has also been
approved in South Korea and Taiwan.
� Micafungin, an injectable antifungal agent and
Fujisawa’s third global product following Prograf ®
and Protopic®, is at the final stage of development.
A New Drug Application was filed in Japan in June
2001, followed by NDAs in the US in April 2002
and in Canada in June 2002.
7
(For the year ended March 2002)
8
JapanEthical PharmaceuticalsThe Japanese pharmaceutical market reg-
istered growth of 3-4 percent for the year
ended March 2002 according to media
reports, mainly because there was no price
cut on the National Health Insurance Drug
Price List. However, an overall 6.3% price
cut implemented in April 2002 is expected
to hit the Japanese market hard in the year
ending March 2003.
In this climate, Fujisawa was able to expand
its domestic ethical pharmaceuticals business
in the term mainly thanks to the full-year
contribution of products launched in the pre-
vious fiscal year, in particular, the hypnotic
Myslee ® (zolpidem tartrate) in December
2000, and the atypical antipsychotic agent
Seroquel ® (quetiapine fumarate) launched in
February 2001. These products together with
the antidepressant Luvox ® (fluvoxamine
maleate) have pushed Fujisawa to the number
one place in the central nervous system
(CNS) drug market in Japan.
Further, the Company succeeded in acquiring
two products already on the market in its
anti-infective product line during the term,
the glycopeptide antibiotic Targocid ® Injection
(teicoplanin) from Aventis Pharma Ltd., and
the 4th-generation injectable cephem
antibiotic Keiten® (cefpirome sulfate) from
Chugai Pharmaceutical Co., Ltd. Fujisawa
started distr ibution of Targocid ® Injection,
which has a stronger antibacterial effect on
MRSA than existing products, in January
2002. The Company also started marketing
and promotional activities for Keiten® in
March 2002.
Currently, promotional activities for Fujisawa
products are carried out by about 1,100 med-
ical representatives (MRs) deployed nation-
wide. Of these, about 110 MRs are assigned
as a special sales force focusing on dermatolo-
gists, pediatricians, ophthalmologists and
otorhinolaryngologists, in the general practi-
tioner market. Further, the number of antipsy-
chotics managers has been nearly doubled
9
capsules to the North American market,
which had previously been served by Fujisawa
Ireland, was commenced in January 2002.
Further, production of Protopic ® (tacrolimus
ointment) for the Japanese market has been
switched to new facilities for formulation and
packaging at the Toyama plant from the
Grand Island, New York plant of Fujisawa
Healthcare, Inc. since the spring of 2002.
The production of micafungin is divided
among the three Japanese plants of the
Company — fermentation at the Nagoya
Plant, synthesis in Toyama, and formulation
and packaging at the Takaoka Plant. All the
facilities are now operational and await the
start of commercial production of micafungin
upon receipt of approval.
OTC DrugsFujisawa’s OTC drug business covers a wide
range of therapeutic categories from Precol ®
brand cold remedy, anti-allergic AG Nose and
AG Eyes, Neuvita® Gold vitamin preparations,
and Pyroace® brand remedy for athlete’s foot,
to Fujipap® anti-inflammatory and analgesic
plasters, and Eva Youth® women’s health prod-
ucts. On top of sales and marketing activities
fully utilizing information technology,
Fujisawa actively pursues business expansion
through introduction of new products,
including line extensions of existing products.
New products launched during the year
ended March 2002 include: Privie ®7 and
Privie®10 medicinal lotion for skin care, New
Fujisawa Urea Cream 20% medicinal cream for
skin care for topical use, Eurax® Cool Spray,
and Eurax® Cool Liquid.
Fujisawa Japan coversthe full range of thera-peutic areas. To suc-ceed in the fiercecompetition in thepharmaceutical market,a comprehensive mar-keting strategy cov-ering all our productsis crucial. It is myassignment to con-tribute to the achieve-ments of our sales forceby analyzing the mar-ket, creating productportfolios, and coordi-nating upcoming newproduct launches suchas micafungin andProtopic® for pediatricuse.
Takahide KitadaAssociate DirectorProduct Planning &Marketing
from the level of two years ago. An increase in
the number of sales offices from 71 to 99 on
reshaping the field organization effective April
2002 has now enabled the MRs to more
intensively cover their territories.
As for production, the Toyama Plant now
supplies Prograf ® (tacrolimus) capsules both to
Japan and North America. Supply of Prograf ®
10
North AmericaProtopic® is the latest product offered in the US
by Fujisawa Healthcare, Inc. located in
Deerfield, IL. Since its debut in early 2001,
Protopic® has been widely appreciated as a new
therapeutic alternative to conventional thera-
pies since the introduction of topical steroids
more than 40 years ago. This important addi-
tion to the product portfolio illustrates the
growing presence of Fujisawa Healthcare in
the US pharmaceutical market.
With a workforce of over 700, Fujisawa
Healthcare, Inc. is instrumental in promoting
the global business development of Fujisawa.
The current product portfolio offers pharma-
ceuticals in the immunology, anti-infective
(systemic antifungal infections), cardiovascular
(pharmacologic stress imaging, etc.) and der-
matology therapeutic areas.
Prograf ® is the leading product for Fujisawa
Healthcare and showed a sales increase of more
than 20%. Prograf ® is now used for nearly 85%
of new patients receiving a liver transplant.
Currently, more than 50% of new kidney
transplant recipients take Prograf ®, and this
number continues to grow.
The pharmacologic stress imaging agent
Adenoscan® (adenosine injection), together
with Adenocard ® (adenosine injection) for
paroxymal supraventr icular tachycardia
(PSVT), is a key product in the cardiovascular
franchise. Adenoscan® leads a growing pharma-
cologic stress imaging agent market with over
50% market share. The systemic antifungal
agent AmBisome® (liposomal amphotericin B)
also increased its sales in a fiercely competitive
marketplace.
Fujisawa Healthcare is very active in clinical
development and is also seeking opportunities
for in-licensing and product acquisition.
Evidence of this can be seen in the
completion of the clinical development pro-
gram for micafungin and the submission of a
New Drug Application to the FDA at the end
of April 2002.
11
In dermatology, Fujisawa Healthcare
acquired the exclusive North American mar-
keting and distribution rights to Atrisone ®, a
dapsone topical gel from Atrix Laboratories,
Inc. in October 2001. Atrisone ® is currently
in Phase III clinical studies for the treatment
of acne and in pilot studies for additional
indications.
Further, clinical studies are ongoing both for
CVT-3146, a selective A2a agonist as a second
generation pharmacologic cardiac stress imaging
agent from CV therapeutics, and for the
injectable formulation of DTI-0009, a selec-
tive A1 agonist for the treatment of atrial fib-
rillation and flutter and PSVT from Aderis
Pharmaceuticals, Inc.
The Grand Island, New York plant of Fujisawa
Healthcare for the formulation and packaging
of Protopic®, manufactures the product for the
North American market and the European
market (for Europe, formulation only).
In Canada, Fujisawa Canada, Inc., a wholly
owned subsidiary of Fujisawa Healthcare, is
expanding its business thanks to Prograf ®.
Further, Fujisawa Canada launched Protopic® in
September 2001 and obtained approval for the
extension of the indication for AmBisome®.
The Canadian launch of Protopic®, the third in
the world, came just seven months after its US
launch.
Cefdinir is marketed as Omnicef ® by Abbott
Laboratories in the US. Omnicef ® doubled its
sales to $88 million in 2001. While Omnicef ®
is available in capsule and oral suspension for-
mulations, its better tasting oral suspension
formulations are widely accepted because taste
is especially important for children. Omnicef ®
has now become the fourth-best-selling
antibiotic suspension product in the US, and
is an integral part of Abbott’s anti-infective
portfolio.
Accepting responsibilityfor growth and develop-ment, Fujisawa Health-care, Inc. is committedto excellence. Throughtraining and develop-ment, we will continueto provide the necessarytools that will enable allFujisawa Healthcare,Inc. employees to developand operate at thehighest level of profes-sionalism and salessuccess.
Karen L. TurnerManager, Sales TrainingHospital ProductsFujisawa Healthcare, Inc.
12
EuropeFujisawa GmbH, the European Headquarters
of Fujisawa, celebrated its 10th anniversary in
February 2002. Since its inception in 1991,
Fujisawa GmbH has been steadily growing,
driven by sales of Prograf ®. 1,300 people of
more than 30 nationalities now work for
Fujisawa GmbH and its subsidiaries, located in
Germany, France, the UK, Italy, Spain,
Austr ia, and Sweden, where Fujisawa
Scandinavia AB was established in April 2001.
Fujisawa GmbH also carries out promotional
activities in the Benelux countries, Ireland,
Poland, the Czech Republic and Hungary.
In the network of Fujisawa GmbH, Fujisawa
Deutschland GmbH has strategic significance.
The reorganization of Fujisawa’s European
operations in order to improve operational
efficiency and profitability, announced in
January 2001, culminated in the creation of
Fujisawa Deutschland GmbH in January 2002.
Fujisawa Deutschland GmbH, located in
Munich, was formed through the merger of
the German operations of Fujisawa GmbH
into Klinge Pharma GmbH. Pr ior to the
merger, Fujisawa GmbH acquired the remain-
ing minority stake at Klinge and made it a
wholly owned subsidiary.
Fujisawa Deutschland GmbH focuses on sales
and marketing activities, covering both hospi-
tal and general practitioner markets in the
German-speaking countr ies — Germany,
Austr ia and Switzerland. Its product
portfolio includes Prograf ®, Protopic ®, the oral
cephalospor in antibiotic Suprax® (cefixime),
the lipid-lowering agent Cranoc ® (fluvastatin),
anti-asthmatics and oncology products.
Further, in order to reinforce the product
portfolios not only of Fujisawa Deutschland
GmbH, but also of the entire European
operations of Fujisawa, in-licensing and
product acquisition activities are also pursued.
I have been working forFujisawa GmbH forthree years focusing onthe submission andsuccessful registration ofProtopic® in Europe —an exciting and chal-lenging project. Workingin an internationalenvironment and beinginvolved in the devel-opment and registra-tion of innovativemedicinal products ishighly motivating andI look forward to thenext goal, i.e. the sub-mission of the marketingauthorisation applicationfor micafungin in Europe.
Rosa Maria KleinSenior Manager, Regulatory AffairsFujisawa GmbH
13
Prograf ® is now commercially available in 18
European countries, with the latest launch in
Romania in March 2002. Of those, 16 coun-
tries are covered by Fujisawa affiliates, while
Portugal and Greece are covered by local part-
ners. The European launch of Protopic ® started
in Switzerland in January 2002. On February
28, the European Commission issued a
Marketing Authorization for Protopic ® valid
throughout the European Union, and in
Norway and Iceland. Following the launch of
Protopic® in Germany and the UK, both in
April, Protopic® was launched in Ireland in
May, Sweden in June and Austria early July.
Protopic® will soon be available in France, Italy
and other European countries.
At the 20th World Congress of Dermatology
in Paris, France early July 2002, Protopic ®
received high marks from the audience and is
being recognized as a new therapeutic option
for atopic dermatitis.
Fujisawa Ireland Limited, located in Killorglin,
serves as a base for the formulation and pack-
aging of Prograf ® ampoules and capsules to the
world market except for capsule formulations
to Japan and North America, as well as the
packaging of Protopic® to the European market.
In addition to coverage by the Fujisawa group
as Suprax ® in Germany and Aerocef ® in
Austr ia, cefixime is available in many
European countries through local partners,
under various names such as Oroken®, Suprax®
and Cefixoral ®. A dispersible tablet formulation
of cefixime has been added to the product line
in Italy since January 2002, and is now well
accepted.
14
Fujisawa has its own business operations inTaiwan and South Korea and has gained afoothold in China through its Hong Kongaffiliate. The Company also has local partnersin the region to distribute its products, mainlythe cephalosporin products.
Fujisawa Taiwan Co., Ltd., which celebratedthe 40th anniversary early 2002, is positionedamong the top-tier pharmaceutical companiesin Taiwan. The Company’s Taiwan operationscover the whole range of functions from clini-cal development and manufacturing to salesand marketing. They cover a wide range ofproduct categories comprised of in-housegenerated products of Fujisawa, such asPrograf ® and Cefspan® (cefixime), as well asproducts from partners, such as the anti-asthmatic and anti-allergic Intal ® (sodium cro-moglicate). Stilnox® (zolpidem tartrate) fromSanofi-Synthelabo of France has beenrobustly growing since its launch in June 1997and now holds the first place in the salesrankings of Fujisawa Taiwan. The antiglau-coma Rescula® (isopropyl unoprostone) fromR-Tech Ueno, Ltd. is another new productlaunched in December 2001. Fujisawa Taiwanreceived marketing approval for Protopic ® inDecember 2001 and plans to launch it in thesummer of 2002.
As for the huge Chinese market, Fujisawaoperates the Prograf ® business throughFujisawa Hong Kong Ltd., a wholly ownedsubsidiary of Fujisawa Taiwan. Sales ofPrograf ® have been expanding since its launchin 1997 thanks to promotional activities byFujisawa Hong Kong through its offices inHong Kong, Beijing, Shanghai andGuangzhou. Protopic ®, filed in China inSeptember 2001, is now under review by thegovernment authorities. Apart from Prograf ®
and Protopic®, the Company’s products are dis-tributed through local partners.
In South Korea, Fujisawa Korea Ltd. is responsi-ble for the Prograf ® business and has succeededin expanding sales of Prograf ®. Further, FujisawaKorea is now ready to launch Protopic®, whichreceived marketing approval in October 2001. Inthe oral cephalosporin market in South Korea,Suprax® by Dong A Pharmaceutical Co., Ltd.has kept the position of top brand product andOmnicef ® has become the fourth-best-sellingbrand product since its launch by JE ILPharmaceutical Co., Ltd. in 1999.
AsiaWorking smart – focus,flexibility and futureprospect (3F spirit) tocope with FujisawaTaiwan’s fast growth isalways my best guidelineas a frontline managerworking in Taichung,central Taiwan. Thanksto the strong supportfrom the Company andco-operation from ourcolleagues, the businessis running well. I aim toreach another recordhigh as my present toFujisawa Taiwan incelebration of its 40thanniversary this year.
Ming-Juu PengSupervisorTaichung OfficeFujisawa Taiwan Co., Ltd.
15
No.1 Prograf®
¥72.4 billion Immunosuppressants
No.2 Cefzon®
¥28.4 billionOral cephalosporin
No.3 Adenoscan®
¥19.2 billionPharmacologic stress imaging agent
No.4 Intal®¥14.1 billionAnti-asthmatic and anti-allergic
No.5 Nivadil®¥12.9 billionAntihypertensive
No.6 AmBisome®
¥11.8 billion Antifungal
No.7 Cefamezin®
¥11.5 billionInjectable cephalosporin
No.8 Cefspan®
¥9.3 billionOral cephalosporin
No.9 Protopic®
¥8.8 billionTopical immunomodulator
No.10 Dogmatyl®¥8.3 billionAnti-ulcer and neuroleptic
(Year ended March 31, 2002)
Top Ten Ethical Pharmaceuticals by Sales
16
Other Businesses
Non-invasive Intermittent Positive Pressure
Ventilation (NIPPV). Two home-care medical
devices provided by the US-based Respironics,
Inc., the BiPAP ® series for NIPPV, and the
CPAP system for SAS, are jointly promoted by
Fujisawa with Fuji RC, Ltd., the largest mar-
keter of home-care respiratory care devices in
Japan and the Japanese agency of Respironics,
Inc.
The Medical Supplies and Systems Business
of Fujisawa is an exclusive distr ibutor in
Japan of reagents of PharMingen and
Immunocytometry Systems of BD Biosciences,
a business unit of Becton Dickinson and
Company. We also exclusively distribute DNA
FISH (fluorescence in situ hybridization)
probes and instruments manufactured by Vysis,
Inc. of the US. Flow cytometory reagents, of
both PharMingen and Immunocytometry
Systems, are widely used in fields ranging from
basic research in immunology through disease
diagnosis. Genosensor ®, made by Vysis, which
includes genomic microarrays, reagents,
instrumentation and analysis software,
simultaneously detects gene copy number pages
from 287 target genes. In a move to expand the
Vysis line, Fujisawa launched the PathVysion®
HER-2 DNA Probe Kit (PathVysion) in Japan
in March 2002. PathVysion® is an in-vitro
diagnostic kit used to detect amplification of
HER-2 gene in human breast cancer tissues
and/or cells accurately by FISH. Fujisawa also
markets tests such as urine test sticks and stool
occult blood tests.
The Home Care Business, conducted solely
in Japan, has been growing since the start of
operations in 1995. Home Oxygen Therapy
(HOT) is so far the main area of service,
and Fujisawa now serves nearly 15% of the
Japanese HOT market. The service includes
Home Infusion Therapy (HIT), Continuous
Positive Airway Pressure (CPAP) for Sleep
Apnea Syndrome (SAS), and BiLevel for
17
leading position in their respective markets
worldwide. Among these, Sodium Gluconate and
sodium erythorbate have long been used in a
variety of areas including food processing, bottle
washing, metal surface treatment and so on.
The safe and useful properties of these old but
new products are expected to provide opportu-
nities for much wider use with the chemicals
business. The chemicals business, with the full
range of capabilities from product development
and manufacturing to marketing, is engaged in
by the parent company and PMP Fermentation
Products, Inc. headquartered in Peoria, Illinois.
The Nagoya Plant in Japan and PMP’s plant in
Illinois serve as production bases for industrial
chemicals and food additives.
Fujisawa divested its animal health business,
with annual sales of about two billion yen, in
June 2001. Further, the concrete admixture
business of the Company is now operated in
the form of a joint-venture company with
NIPPON PAPER INDUSTRIES CO., LTD.
This new venture, in which Fujisawa owns
34% equity, started operations in April 2001.
Fujisawa currently holds 50.1% of the shares of
Daisan Kogyo Co., Ltd., the largest manufac-
turer of industrial cleaning and hygiene prod-
ucts for the brewing and beverage industry in
Japan. These shares are scheduled to be
transferred to the minority shareholder in
November 2003.
I have been working forPMP Fermentation foralmost 15 years. I amworking hard to makeour products the highestquality and the mostcompetitive in theworld. These challengesinspire my motivations,and I have a brightoutlook on the future.
Dennis HuffDirector of CorporatePlanningPMP FermentationProducts, Inc.
The Chemicals Business now focuses on
industrial chemicals and food additives in order
to improve management efficiency and prof-
itability. The current product line is composed
of the chelating agent and food additive Sodium
Gluconate, the food antioxidant Eribate® (sodium
erythorbate), the food acidulant Fujiglucon®
(glucono delta lactone) and the calcium fortifier
Calcium Gluconate. These products enjoy a
18
R&D ActivitiesAs a research-driven pharmaceutical company, Fujisawa’s research and develop-
ment activities are the key to its success in the highly competitive global market.
To discover innovative products satisfying unmet medical needs, Fujisawa has
been investing heavily in research and development activities. The figure for the
year ended March 2002 was ¥57,093 million (US$429 million), giving a
ratio to net sales of 16.7%.
19
Under the banner of “speed, focus and flexibil-
ity,” Fujisawa is deeply committed to innova-
tive research to satisfy unmet medical needs. Its
research activities currently target the discovery
of compounds to be recognized as “best in the
class, first in the class” in the four therapeutic
categor ies on which Fujisawa focuses —
immunology/inflammation, cerebral diseases,
metabolic diseases and infectious diseases.
Organization and Network
Fujisawa’s research activities are conducted
mainly at the 10 domestic laboratories located
in Osaka, Tsukuba and Nagoya. The Company
also owns satellite research laboratories over-
seas: Fujisawa Research Institute of America,
Inc. in collaboration with Northwestern
University, and The Fujisawa Institute of
Neuroscience in Edinburgh, a collaborative
research venture between Fujisawa and the
University of Edinburgh.
In full recognition that methods of drug discovery
are changing dramatically along with the rapid
progress of molecular biology, Fujisawa is very
keen on strengthening its strategic collaboration
with outside institutions or emerging research
ventures that possess novel technologies or
ideas for drug discovery. Through Fujisawa
Investments for Entrepreneurship, L.P. I&II
(FITE I&II), the Company is continuously
seeking equity investments in start-up pharma-
ceutical research ventures. As of July 2002,
FITE I&II have made seven investments in
research ventures scattered across North
America, Europe and Asia. Among these
seven, an investment in a Taiwan venture was
the first one jointly made by FITE I&II.
In June 2001, Fujisawa reorganized its
Development Division in order to strengthen
its function as the global development head-
quarters. The division has been subdivided
into a global development group and a local
(Japanese) development group. The global
development group promotes the global
development of Fujisawa products speedily and
efficiently.
� Genomic Research
In addition to in-house activities, genomic
research of the Company is enhanced through
various joint projects. Fujisawa is currently
collaborating with Quark Biotech, Inc. to dis-
cover stroke-related genes and to develop
promising new medicines for the treatment of
strokes. The Reverse Proteomics Research
Institute, set up by other Japanese companies
along with Fujisawa, studies co-action
between small molecule compounds and pro-
teins expressed from full-length cDNA clones
gained through the research activities of Helix
and other institutions. The Pharmaceutical
Consortium for Protein Structure Analysis, in
which Fujisawa participates along with 21
Japanese pharmaceutical companies, is due to
start its research in October 2002.
20
� Microbial Product Research
Fujisawa has excellent records in microbial
product research based on its renowned fer-
mentation technology. Even though genomic
research offers new opportunities for drug dis-
covery, Fujisawa believes that microbial prod-
uct research of the Company, endorsed with
generation of such compounds as tacrolimus
and micafungin, is a viable method for drug
discovery. In this area, as the bio-diversity of
microorganisms depends on ecological and
environmental factors, Fujisawa has been col-
laborating with the Malaysian companies
SIRIM Berhad and TropBio Research Sdn.
Bhd. since 2000, and expects its microbial
product library to expand. In this bilateral col-
laboration, Fujisawa is committed to transfer
its technology to its Malaysian partners.
Tacrolimus Development
Clinical development of Protopic ® has almost
been completed. It is now moving to the mar-
ket launch stage, as illustrated in the world-
wide operations of this annual report. In the
area of auto-immune diseases, Phase III studies
for chronic rheumatoid arthritis are underway
in Japan and the US, while Phase II studies are
underway in Europe. Phase III for inflamma-
tory bowel disease, Phase II studies for lupus
nephritis, and Phase II for vernal conjunctivitis
and perennial allergic conjunctivitis with eye
drop formulation are ongoing in Japan. Phase
II studies for psoriasis by gel formulation in the
US, and Phase II for dry-eye with eye drop
formulation by Sucampo Pharmaceutical, Inc.
in Europe are also underway.
Micafungin Development
Micafungin is an injectable antifungal agent
and a member of the echinocandin group that
specifically inhibits fungal cell-wall synthesis.
Along with a high safety profile, micafungin
shows excellent efficacy against both candidia-
sis and aspergillosis, major invasive infections
caused by fungi. An NDA for micafungin was
filed in Japan in June 2001, and was submitted
in the US in April 2002 and in Canada in
June 2002. Fujisawa also plans to file an NDA
for micafungin in Europe soon.
Other Products under Clinical Development
� Cerebral Diseases
FK960 is expected to be effective in treating
memory impairment, which is a core symp-
tom of Alzheimer’s disease, and Phase II for
antidementia is underway both in Japan and
the US. FK960 for cognitive disorder in schiz-
ophrenia is also in Phase II in Europe.
Seroquel®, commercially available as an atypical
antipsychotic agent, is in Phase II for psy-
chogenic symptoms and behavior disorder in
dementia in Japan.
The extraordinary effortsof a worldwide develop-ment team for micafun-gin resulted in NDAfilings in Japan, theUSA, Canada and sched-uled filings in Europe.Ten clinical trials inpatients across fourcontinents, along withpreclinical and volunteerdata, have demonstratedthe efficacy and safety ofthis important newantifungal agent.
Donald Buell, Ph. D.Senior Medical Director,Research and DevelopmentFujisawa Healthcare, Inc.
21
◆ Metabolic Diseases
FK614 is an insulin sensitizer expected to have
potent hypoglycemic effects. FK614, a benz-
imidazole derivative, has a molecular structure
different from glitazones and is in Phase II for
non-insulin dependent diabetic mellitus in
both Japan and the US.
◆ Immunology and Inflammation
FK778, an immunosuppressant, has a novel
mechanism that inhibits bio-synthesis of
pyrimidine in both T-cell and B-cell. FK778 is
expected to have a synergistic effect with
Prograf ®, and Phase II clinical studies of FK778
for the prophylaxis of rejection in kidney
transplant patients in combination with
Prograf ® are currently progressing in Europe.
◆ Other Diseases
Abciximab is a chimeric monoclonal antibody
fragment targeted at GP IIb/IIIa receptors.
Fujisawa has licensed abciximab from
Centocor, Inc. and it is now in Phase II for use
in high-risk angioplasty in Japan. JTE-522, a
cyclooxygenase-2 (COX-2) inhibitor, is an
oral anti-inflammatory agent licensed from
Japan Tobacco Inc. (JT). Phase II study of
JTE-522 for chronic rheumatoid arthritis,
osteoarthr itis, etc. is ongoing by JT and
Fujisawa will participate in Phase III onwards.
FK352B, an adenosine A1 antagonist, is in
Phase II study for dialysis-induced hypotension
in Japan. Phase II clinical studies for FK228, a
histone deacetylase inhibitor anticancer, have
started in the US.
Products under Clinical Development
Japan
immunosuppressant (chronic rheumatoid arthritis)
immunosuppressant (chronic rheumatoid arthritis)
immunosuppressant (atopic dermatitis in pediatric population)
antifungal (deep-seated fungal infection)
antifungal (deep-seated fungal infection)
monoclonal antibody to GP IIb/IIIa receptors
Antidementia (Alzheimer’s disease)
Antidementia (Alzheimer’s disease)
insulin sensitizer (non-insulin dependent diabetes mellitus (NIDDM))
insulin sensitizer (non-insulin dependent diabetes mellitus (NIDDM))
anticancer
North America
Europe
immunosuppressant (lupus nephritis)
immunosuppressant (vernal conjunctivitis and perennial allergic conjunctivitis (eye drops))
immunosuppressant (inflammatory bowel disease)
Prograf ®
Prograf ®
Prograf ® tacrolimus (FK506)
tacrolimus (FK506)
tacrolimus (FK506)
tacrolimus (FK506)
tacrolimus
Prograf ® tacrolimus (FK506)
micafungin (FK463)
(FK506)
micafungin (FK463)
Protopic®
ReoPro® abciximab
FK960
FK960
FK614
FK614
FK228
Product Name Generic Name Product Category Phase II Phase III Filed
immunosuppressant (chronic rheumatoid arthritis)Prograf ® tacrolimus (FK506)
micafungin (FK463) antifungal (deep-seated fungal infection)
immunosuppressant (heart transplant)tacrolimus (FK506)Prograf ®
immunosuppressant (psoriasis (gel))tacrolimus (FK506)
immunosuppressant (dry-eye (eye drops))
immunosuppressant (prophylaxis of organ rejection in liver and kidney transplants)
tacrolimus (FK506)
FK778
(cognitive disorder in schizophrenia) FK960
adenosine Al antagonist (dialysis-induced hypotension)
(behavior psychological symptoms of dementia)
COX-2 inhibitor (chronic rheumatoid arthritis, osteoarthritis etc.)
Seroquel® quetiapine fumarate (FK949)
tilmacoxib (JTE-522)
FK352B
22
Environmental Measures
Fujisawa has set numerical targets for its main
environmental conservation activities. For
example, all energy consumption is calculated
in the form of CO2, as reductions in energy
use indirectly prevent global warming.
We have succeeded in substantially reducing
the emission of landfill waste through our ini-
tiatives for the reduction and recycling of dis-
posables.
Environmental Protection
It is Fujisawa’s policy to ensure that all aspects
of its activities are in harmony with the envi-
ronment. Fujisawa’s global environmental
conservation activities are based on the
“Fujisawa Environmental Principles,” which
are supplemented by the “Fujisawa
Environmental Guidelines” as a practical
guide enabling all group companies to effec-
tively implement the Principles. While the
Principles were renamed to the current name
in 2000, the Guidelines were newly elabo-
rated in 2001.
During the year ended March 2002, in-house
environmental auditors of Fujisawa carried
out on-site audits at fifteen facilities in Japan
to check that environmental management
activities based on the Principles were being
carried out. As a result of the acquisition dur-
ing the term of ISO 14001 certification by
the Irish plant of Klinge Pharma GmbH (now
Fujisawa Deutschland GmbH), the number of
facilities that have obtained ISO 14001 certi-
fication increased to 6 out of the 14 facilities
engaged in manufacturing. The Irish plant of
Fujisawa Deutschland GmbH was also
selected as the winner of the “Environmental
Management Award for Sustainable
Development” for 2001 of Ireland. As the
best facilities in Ireland, the Plant will repre-
sent Ireland at this Award at the European
level in October 2002.
1996 19981997 1999 2000 2001 2002(Target)
300
250
200
150
50
100
0
(tons) (%)120
100
80
60
40
20
0
Landfill Waste (Klinge Pharma GmbH)Volume Ratio (1996 = 100)
Years to December 31
1991 1992 1993 1994 19961995 1997 1998 1999 2000 2001 2002 2006(Target)
14,000
12,000
10,000
8,000
6,000
2,000
4,000
0
(tons) (%)140
120
100
80
60
40
20
0
Landfill Waste (Japan)
Years to March 31
Volume Ratio (1991 = 100)
1991 1994 1995 1996 19981997 1999 2000 2001 2002 2011(Target)
140,000
120,000
100,000
80,000
60,000
20,000
40,000
0
(tons) (%)130
120
110
100
90
80
70
60
Emmision of CO2 (Japan)
Years to March 31
Volume Ratio (1991 = 100)
23
We have finishedexpanding the facilitiesat the Toyama Plant forthe manufacture ofPrograf ®, Protopic® andtacrolimus drug sub-stance as well as mica-fungin drug substance.Environmental protec-tion is one of the toppriorities of the plantmanagement. We havefurther enhanced thetraining of our staff toimplement the FujisawaEnvironmentalPrinciples, and haveachieved a constantimprovement in envi-ronmental performance.
Yasutada ShirakuraDirector, TechnicalToyama PlantManufacturing
Further, the staff responsible for our manufac-
turing facilities that use large volumes of
organic solvents are now tackling the task
of recycling more than ten different kinds
of solvents and re-using more than forty-
thousand tons of organic solvents per annum.
The proper management of chemical sub-
stances is an issue of the highest significance
for Fujisawa, and the Company is taking steps
to reduce the volume of pollutants, find
substitutes for such substances, and curtail
emissions.
Environmental Accounting
In the year ended March 2002, Fujisawa
introduced environmental accounting in the
parent company as a tool to improve the cost
performance of environmental conservation.
“Deemed effects” resulting from the imple-
mentation of measures to reduce environ-
mental r isks were not calculated, but
described only in a qualitative manner for the
first year’s environmental accounting. We
intend to measure these “deemed effects” on
a monetary basis.
1996 19991998 2000 2001 2002 2011(Target)
2006(Target)
600
500
400
300
100
200
0
(tons) (%)120
100
80
60
40
20
0
Air Emission of Dichloromethane (Japan) Volume Ratio (1996 = 100)
Years to March 31
Environmental Costs
Category Details Value (¥ Million)
Environmental Benefits
Category Details Value (¥ Million)
1) Costs within business area
1. Pollution control cost
2. Environmental protection cost
3. Resource conservation cost
Water quality, prevention of air pollution
Energy conservation, protection of ozone layer
Reduction of waste, recycling of solvents and used paper
2) Upstream / downstream cost Bottle recycling
3) Management cost ISO 14001 certification, environmental education and training
4) Technology cost Development of new environmental technology
5) Social activity cost Social contribution efforts, donations
6) Environmental damage cost Accidents or lawsuits relating to the environment
Total
817
1,061
708
961
1,021
2,946
60
48
25
18
0
0
158
164
a. Resource conservation Cost saving by in-house refining of solvents
b. Sale of disposables
c. Sale of valuable waste
d. Energy conservation
e. Reduction of waste handling expenses
Total
Revenue from sale of solvents, activated sludge, etc.
n.a.
Reduction of energy expenses resulting from energy conservation measures
Reduction, reuse and recycling of waste
Note: Approximately ¥1.2 billion was invested in environmental protection.
2,095
24
Board of Directors
Akira FujiyamaChairman of the Board
Michio IidaVice Chairman and Chief Financial Officer
Hatsuo Aoki, Ph. D. President and Chief Executive Officer
Koichi SejimaCorporate Executive Vice President andChief Administrative Officer
Tomokichiro Fujisawa, Ph. D.Chairman Emeritus
Akiro KojimaMember of the Board (Senior Counselor, Daicel Chemical Industries, Ltd.)
Kanji KobayashiMember of the Board (Senior Advisor, Nippon Life Insurance Company)
Members of Management Committee(Front row, from left)
Takeshi Shimomura Corporate Executive Vice President, Sales & Marketing
Hatsuo Aoki, Ph. D. President and Chief Executive Officer
Hideo TanakaCorporate Senior Vice President, External Relations
(Back row, from left)
Masafumi NogimoriCorporate Senior Vice President, Global Strategy
Michio Iida Vice Chairman and Chief Financial Officer
Koichi SejimaCorporate Executive Vice President and Chief Administrative Officer
Shuji InoueCorporate Senior Vice President, Overseas Operations