Results Briefing - Tsumura · Results Briefing Junichi ... Shizuoka Plant (Granulating and...

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Fi lY Fi lY Fiscal Y ear Fiscal Y ear Ended March 2011 Ended March 2011 Ended March 2011 Ended March 2011 Results Briefing Results Briefing Junichi Yoshii Junichi Yoshii President & Representative Director T &C T sumura & Co. May 13 2011 May 13, 2011

Transcript of Results Briefing - Tsumura · Results Briefing Junichi ... Shizuoka Plant (Granulating and...

Fi l YFi l YFiscal YearFiscal YearEnded March 2011Ended March 2011Ended March 2011Ended March 2011

Results BriefingResults Briefing

Junichi YoshiiJunichi YoshiiPresident & Representative Director

T & CTsumura & Co.

May 13 2011May 13, 2011

Contents

Fi l Y E d d M h 2011 Fiscal Year Ended March 2011Overview of Results (Including impact of the earthquake)

Forecast for the Fiscal Year Ending March 2012 (Including impact of the earthquake)( g p q )

Progress of Actions for the Six Goals

1

Impact of the Great East Japan Earthquake - 1 - Operation resumed in stages on aIbaraki Plant

Shut down on March 11

- Operation resumed in stages on a process-by-process basis

- Operation fully resumed on May 10

Plant zone

Operation fully resumed on May 10(Location: 3586 Yoshiwara, Ami-machi, Inashiki-gun, Ibaraki)

Typical production flow for Kampo preparations (bulk) Powdered

extract

Extract granules

Granule container

Weighing and mixing

Automated warehouse for crude drug

Boxed crude drug

Cutting

Extracting Spray-drying

Powdered extract

Lactose

Mixing

Roll crusher

container

Mixed herbs

Chopped herbs

Powdered extract

Tableting

Intermediates to go to the side of the

automated warehouse

Granules to go to the side of the automated

warehouse

Granulation Filling and packagingCrude drug as WeighingCutting Extraction Drying Granulation Filling and packagingCrude drug asraw materials

Weighing and mixing

Cutting Extraction,separation,

and concentration

Drying

Resumed on April 4

Resumed on April 13

Resumed on May 10Minor damages

All processes were resumed on May 10

2

Impact of the Great East Japan Earthquake -2

F iliti I t

Damage and recovery at facilities other than Ibaraki Plant

Facilities ImpactIshioka Center(Location: 7-2 Kashiwabara

Suspended for inspections and other purposes. Operations at certain crude drug processing lines(Location: 7-2, Kashiwabara,

Ishioka-shi, Ibaraki)Operations at certain crude drug processing lines was resumed on March 24. All functions were resumed on April 11.

Laboratory(Location: 3586 Yoshiwara, Ami-machi, Inashiki-gun, Ibaraki)

Checks of precision equipment were conducted. Quality tests of Kampo preparations were resumed on March 22. Other tests were gradually resumedon March 22. Other tests were gradually resumed and the entire facilities had returned to normal operation by March 28.

E J L i i N i d Ti f ti dj t d fEast Japan Logistic Center(Location: 1584-8, No, Gyoda-shi,

No serious damage. Time of operation adjusted for the rolling blackout.

(Location: 1584 8, No, Gyoda shi, Saitama)

3

Impact of the Great East Japan Earthquake -3 Breakdown of extraordinary loss <Disaster loss>

[FY 3/2011]

Breakdown of extraordinary loss <Disaster loss>

Contents Amount

[FY 3/2011]Damage to facilities, etc. are covered by the

Damage at Ibaraki Plant not covered by the insurance ¥50 million

Damage to other facilities, ¥130 million

insurance. The loss is only for damage not covered by the i

g ,etc. ¥130 million

Fixed costs during the shutdown period ¥350 million

insurance.

shutdown period

Total disaster loss ¥530 millionThe total loss due to damage to equipment, etc. at Ibaraki Plant, which is ,being estimated now, is expected to be below ¥1.0 billion.

4

Measures for Power OutagesMeasures for reducing power consumption at Ibaraki Plant

Supply sources Amount of power needed for production

g p p

25% reductionPower purchase 6,200kW

Power generators 2,100kW

25% reduction Equivalent to

1,550kWg ,

Total 8,300kW

M f d liMeasures for dealing with the power outages

M AmountMeasures Amount supplemented

Power-saving measures 620kWAble to produce as

Power generators (owned by the Laboratory) 400kW

Power generators (rental) 810kW

Able to produce as scheduled.

g ( )Total 1,830kW

5

Fiscal YearEnded March 2011

Overview of Results

6

Overview of Results (Consolidated)

B th l d fit/i d d j ti

Plan 3/2011Difference from plan Year on year

Both sales and profit/income exceeded projections(Million yen)

Plan 3/2011Amount Change

(%) Amount Growth(%)

Net sales 93,100 94,778 1,678 1.8% 3,845 4.2%Operating profit 19,600 21,553 1,953 10.0% 2,614 13.8%Recurring income 19,800 21,725 1,925 9.7% 2,653 13.9%Net income 11,500 12,945 1,445 12.6% 2,241 20.9%

Plan 3/2011 3/2010Operating profit margin 21.1% 22.7% 20.8%

ROA(Return on assets)

13.9% 15.6% 14.5%

Dividend 56 yen 58 yen 46 yen

The year-end dividend was revised upwards by 2 yen, to 30 yen per share. The annual dividend is 58 yen per share

(Dividend per share) 56 yen 58 yen 46 yen dividend is 58 yen per share.

*The dividend (projection) was revised from 52 yen/year to 56 yen/year on November 10, 2010 7

Trend of Net Sales of Tsumura Prescription Kampo Preparations(In Terms of Shipment)

FY2010Net sales of the 129 prescriptions of Tsumura prescription Kampo formulations

continue to grow steadily

FY2010

¥89.2 billion (up 6.5%)

Sales of 105 prescriptions

126 prescriptions The three drug-fostering formulas

continue to grow steadily. Sales of 105 prescriptions increased

100,000

p p g g

79,013 83,78289,247

Total of the129 prescriptions

(6.5%)

(Million yen)

9,054 10,493 12,414 14,875 17,234

60 000

80,000 69,212 73,91079,013

(15.9%)

60 158 63,417 66,599 68,907 72,01340,000

60,000

(4.5%)60,158 63,417

0

20,000Growth

rate

02006 2007 2008 2009 2010 Fiscal year

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Trend of Net Sales of Tsumura Prescription Kampo Preparations (Actual Sales)

FY2010FY2010

¥92.0 billion (Up 7.3%)

Sales of 111 prescriptions

126 prescriptions The three drug-fostering formulas

Sales of 111 prescriptions increased

(Million yen)

15 49317,80780 000

100,000 (7.3%)

(14.9%)70 73775,858 80,890 85,772

92,016Total of the129 prescriptions

9,48111,034 13,004 15,493

,

60,000

80,000 70,737

61,255 64,823 67,886 70,279 74,20840,000 (5.6%)

0

20,000 Growth rate

02006 2007 2008 2009 2010

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Fiscal year

Forecast forForecast for the Fiscal Year

Ending March 2012

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FY2011 Projection -1 (Assumed Net Sales)It is assumed that the growth rate of prescription Kampo preparationsIt is assumed that the growth rate of prescription Kampo preparations

[Results] FY2010 R t f th f < i ti K ti >

It is assumed that the growth rate of prescription Kampo preparationsIt is assumed that the growth rate of prescription Kampo preparationsin FY2011 will be in FY2011 will be 9.4% 9.4% in terms of quantity.in terms of quantity.

Actual Figures Sales ShipmentsQuantity 12.4% 10.1%

FY2010 Rate of growth of < prescription Kampo preparations >

Actual performance value

Amount 7.3% 6.5%

(In actual sales in terms of quantity)

3/2011 First Half Second Half Full YearActual Figures 9.7% 14.8% 12.4%

Changing Rebound: -1.2pReluctance in buying: -1.3pSeasonal influence: -0.8p

Rebound & reluctance inBuying: -1.3pS l i fl 0 0Changing

factorsRebound: 1.2pSeasonal influence: +0.7p

Seasonal influence: 0.8pIncrease in demand due to the earthquake: -3.2p

Seasonal influence: -0.0pIncrease in demand due to the earthquake: -1.7p

Actual Value 9 2% 9 5% 9 4%Actual Value 9.2% 9.5% 9.4%

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FY2011 Projection -2(Million yen)

ff fOriginal

planRevised

plan

Difference from plan Year on year

Amount Change(%) Amount Growth

(%)

N t lNet sales 100,000 100,400 400 0.4% 5,621 5.9%Operating profit 23,400 23,400 0 0 1,846 8.6%Recurring income 23 600 23 600 0 0 1 874 8 6%Recurring income 23,600 23,600 0 0 1,874 8.6%Net income 13,800 13,600 -200 -1.4% 654 5.1%R&D expenses 4,300 4,600 300 7.0% 476 11.6%Capital investments 11,400 12,300 900 7.9% 7,035 133.7%

Operating profit margin 23.4% 23.3% - - 22.7% -

ROA(Return on assets)

15.7% 16.1% - - 15.6% -

Dividend

*The original plan was announced on May 13, 2010

Dividend(Dividend per share)

- 60 yen - - 58 yen Up 2 yen

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FY2011 Projection -3Compared with the original plan:

ItemDifference from the projection (Milli )

Details

Compared with the original plan:

(Million yen)

Net sales 400 The rate of growth of prescription Kampo preparations was 9.4% in volume terms

Th t f l ti b 0 1 t i t (31 4%Cost of sales 200

The cost of sales ratio rose by 0.1 percentage point (31.4% 31.5%)Due to unrealized profit and increase of depreciation

SG&A 200 The ratio of selling, general and administrative expenses SG&A 200 g, g pwas on the same level at 45.2%.

Operating profit 0 Operating margin: 23.4% 23.3%

Recurring income 0Recurring income 0 -

Net income -200 The amount of disaster loss (extraordinary loss) is about 480 million yen.

Fixed costs during the shutdown period ¥270 million

Breakdown of the disaster loss

Rents for power generators ¥210 million

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Capital Investments (Difference from Projection)Design review for productivity improvement Cause

3/2011 3/2012

g p y p Delayed start of the construction of facilities

Cause

(Billion yen)

3/2011 3/2012Original plan (As of May 2010) 8.5 11.4Result and prospect Results 5.2 Plan 12.3Difference -3.3 0.9

(Billion yen)

3/2011 3/2012Ibaraki Plant (granulating building, etc.) -0.9 -0.2

Breakdown of the difference

)Shizuoka Plant (Granulating building, packaging building, etc.) 0.0 -1.8

Shanghai Plant -0 8 0 1Shanghai Plant -0.8 0.1Facilities for crude drug, or botanical raw materials (Ishioka and Shenzhen) -1.1 2.6

Others -0.5 0.2Total -3.3 0.9 14

Breakdown of Capital Investments

Addition of new production facilities including buildings becomes necessary

Increase of crude drug storage capability also becomes necessary

FY2010 FY2011 (Billion yen)(Billion yen)

Contents Amount

Ibaraki Plant (SD line, etc.) 3.0

Shizuoka Plant 0 3

Contents Amount

Ibaraki Plant (Granulating building, SD line, etc.) 3.5

Shizuoka Plant 0.3

Shanghai Plant 0.1

Facilities for crude drug (Ishioka and Shenzhen) 0.6

Shizuoka Plant (Granulating and packaging building and crude drug storage) 1.6

Shanghai Plant (SD building) 2.2(Ishioka and Shenzhen)

Others (Laboratory, etc.) 1.2

Total capital investment 5.2

Facilities for crude drugs (Ishioka) 1.4

Facilities for crude drugs (Shenzhen) 1.3

Facilities for crude drugs (Yubari) 0.7g ( )

Others (Laboratories, etc.) 1.6

Total capital investment 12.3

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Ideas on Capital Investments and Depreciation for the Next Term (FY2012) and Beyond

Prescription Kampo preparations are in the “growth stage.”Construction of facilities for increasing production and

di d d t

14,000

expanding crude drug storage are necessary.(Million yen)

12,30012,000

14,000

Capital Investment

Depreciation

Capital spending is expected to be at the same level as this year, or at around ¥13 billion.

8,000

10,000Depreciation

Depreciation will rise with the increase in capital investments,but not to the extent of raising the

5,237 5,2644,200

3 4533 2254 000

6,000

but not to the extent of raising the cost of sales ratio significantly.

All the amount of capital 3,4533,225

2,000

4,000 investments can be afforded with our own fund.

02009 2010 2011 2012 2013 FY

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Dividend[Basic policy][Basic policy]Aiming to ensure a stable higher dividend, under the perspectives of capital spending, the performance of each term, and the payout ratio etc

Dividend(yen)

Dividendratio (%)

ratio, etc.

30.331.6 31.1

70

80

30

35

303017.8

22.350

60

20

25

17

23

3030

8 1 9.130

4015

20

1017

238 1013

17

3028

8.1

10

20

5

10

6 7 100

2005 2006 2007 2008 2009 2010 2011 Plan0

17FY

Use of Cash Flows

Cash flows from operating activities

I t t f Capital investmentsInvestments for further growth

Capital investmentsIncreasing production facilities, crude drug storage, etc. based on a long-term demand forecast

Repayment of loans RepaymentMaking judgments on repayment as appropriate in

with interest consideration of capital investments, dividends, etc. (A repayment of approx. ¥2.0 billion is planned in FY2011.)

Return to shareholders

DividendAiming to ensure a stable higher dividend, under the perspectives of capital spending, the performance of each shareholders p p p p g, pterm, and the payout ratio, etc.

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Goals and Action Plan

1. Establish Kampomedicin

2. Promote drugfostering and the

evolution of Kampo

3. Internationalize

6. Create an opencompany

Kampo

4. Increase productionit d h th

5. Secure the stablesupply of safer

capacity and enhance thequality control system

crude drug InternationalizeKampo

Secure the stablesupply of safer crude drug

Topics: Explanations about three of the six action goals

Create an opencompanycompany

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Fiscal year

TU-100 Daikenchuto Research and Development Schedule (Japan and US)

Fiscal yearItem 2009 2010 2011 2012 2013 2014 2015 2016 2017

Japa

DKT ForumColon Team In progress: DB-RCT

DKT Forum In progress: DB-RCTan (Drug fosterin

Clinical Pharmacology Team In progress: DB RCT

DKT ForumHepatic Surgery Team In progress: DB-RCT

DKT ForumStomach and Esophagus Team In progress: DB-RCTng, etc.)

Stomach and Esophagus Team

Pharmacokinetic Studies (STEP I & II) Finished

Treatment Outcome Study (Development of Side Effects) In progress

US

(D

Early Phase II (Healthy Subject) Finished

Early Phase II (Patient) (1) In progress

Early Phase II (Patient) (2) In progress*

Hepatic enzyme induction test Finished

Targeted disorder in US:Targeted disorder in US:PostPost--operativeoperative ileusileus (POI)(POI)evelopm

ent)

p y

Pharmacokinetic Studies (ADME) In progress*

Intestinal bacteria (Basic) In progress*

Late Phase II Planned Planbe la

PostPost--operative operative ileusileus (POI)(POI)

Phase III Planned

Phase III Planned

nned to aunched

Expansion of application scope • Items which were being prepared or planned as of the pre io s res lts briefing (No ember 2011)

DB-RCT: Double blind – Randomized Controlled TrialPOI: Postoperative ileus

to be considered in the futureas of the previous results briefing (November 2011)Implemented earlier than scheduled.

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Research on Liquorice Cultivation

Issues concerning liquorice

Dependence on wild speciesDependence on wild speciesDependence on wild speciesDependence on wild species

- Regulations- Exhaustion of resources, etc.

Used for 94 Tsumura prescriptions of Kampo preparationsUsed for 94 Tsumura prescriptions of Kampo preparationsUsed for 94 Tsumura prescriptions of Kampo preparations Used for 94 Tsumura prescriptions of Kampo preparations (approx. 70% of all)(approx. 70% of all)

Research on cultivation commenced in China in 2001.

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Establishment of Liquorice Cultivation Technology

Achievements in Research over Ten YearsAchievements in Research over Ten YearsJoint research partner

China Meheco Corporation/ Beijing University of Chinese Medicine

Achievements in Research over Ten YearsAchievements in Research over Ten Years

partner MedicinePeriod 2001 - 2010 (basic research), 2009 - 2011 (applied research)

Area/harvest 40 ha (Seeds sown in 2009)Area/harvest 40 ha (Seeds sown in 2009) 6 ha of 40 ha harvested (Amount of crude drug harvested: 5.5 tons)

Research 1 Succeeded in realizing high glycyrrhizic acid contentResearch outcomes

1. Succeeded in realizing high glycyrrhizic acid content Average: 3.5%(Minimum: 3.2%, Maximum: 4.0%)

2. Compliance with standards as a raw material of pharmaceutical productspharmaceutical products Compliance with all standards of Japanese

Pharmacopoeia3 Shorter growing season3. Shorter growing season Harvested in fifteen months after seeding

4. Success in large-scale cultivation Improved cultivation efficiency enabled by automationp y y

Patent Patent application in China License in China is free.22

Cultivation of Crude Drug in Laos (LAO TSUMURA)

Farm work in Laos Farm work in LaosFarm work in Laos

Trade name LAO TSUMURA CO., LTD.Established February 19 2010

Farm work in Laos

Established February 19, 2010Main business Cultivation and processing of crude drugFarm area Aprrox. 200ha. Planned to be expanded to 1,000ha in the future.

● Cooperation in school building construction of “Pokem Tsumura Friendship Junior High School”p g

- Site: Laongam, Saravan province (crude drug cultivation area)

- Completion ceremony: March 29 2011Completion ceremony: March 29, 2011Pokem Tsumura Friendship

Junior High School23

Tsumura’s Employment rate of Workers with Disabilities(Employment Measures)

Diversity of Various persons are employed as appropriate

4.50%

Diversity of employment

Various persons are employed as appropriate for individual works.

4.004.00

As of Mar 31 20113.19

3.00

3.50As of Mar. 31, 2011

3.19%

1.95 1 89 1.99 1.972.502.50

1.95 1.89 1.80

1.50

2.00Employment rate required by law: 1.8%

1.00

1.50

2005.3 2006.3 2007.3 2008.3 2009.3 2010.3 2011.3 2012.3As of the

end of 2005.3 2006.3 2007.3 2008.3 2009.3 2010.3 2011.3 2012.3Plan

each year

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Employment of Workers with Disabilities: Cultivation of Crude Drug

Concluded a consignment contract for the cultivation of crude drug.Opportunities to be employed for crude drug cultivation are given to workers with

“Harunire No Sato” social welfare corporationg g

disabilities.

Investment

Yubari Tsumura Co., Ltd.

“Temiru Farm”farming corporationLtd.

Business description Cultivation of crude drug

Ishikari-shi, Hokkaido

p gNumber of employees 3 able-bodied workers, 10 workers with disabilities (plan)Details of the crude drug cultivation

Test cultivation of crude drug (cnidium rhizome, perilla herb)cultivation

* Temiru FarmA farming corporation established in 2010 by “Harunire No Sato” to help people with mental disabilities to become independent “Harunire No Sato” is a social welfare corporation with 50disabilities to become independent. Harunire No Sato is a social welfare corporation with 50 offices and facilities in Sapporo-shi and Ishikari-shi of Hokkaido

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Contribute to the availability of medicinesf d t d litof unprecedented quality

by combining Kampo and Western medicine

26

For further information, contact

Investor Relations GroupInvestor Relations GroupCorporate Communications DepartmentCorporate Communications Department

Tsumura & Co.TEL: 03-6361-7101TEL: 03-6361-7101

NotesNotes

Data and information provided in this document include so-called forward-lookingstatements. Figures relating to forecasts show our judgments and assumptionsbased on information available and include risks and uncertainty Actual results mightbased on information available and include risks and uncertainty. Actual results mighttherefore differ from expected figures.

The information on pharmaceuticals included is not intended as advertising ormedical advicemedical advice.

Reference

Attached to handouts

Results concerning Tsumura Prescription Kampo Preparations(in Actual Sales in Terms of Quantity)

A growth rate of 9% or higher has been maintained. (Stable growth)

1 4961 600(10,000 preparations)

1 2381,331

1,496

1,400

1,600

9421,019

1,109

1,238

1,200Average

811 799741

655 639 664 687 719802 815

900 942

800

1,000g

quantity

Up 9.6%Average quantity

Up 8.5%Average655 639 664

600 Average quantity

Up 7 0%

Average quantity

Up 7.5%

200

400 Promoting drug fostering

Penetration and establishment of Kampo

Up 7.0%

2001994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

(Fiscal year)

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Top 10 Prescription Kampo Preparation in Terms of Net Sales

Rank Name of Kampo preparations Net sales ChangeRank Name of Kampo preparations Net sales(Million yen)

Change

1 Daikenchuto 7,960 7.2%

2 Hochuekkito 6,218 5.4%

3 Rikkunshito 5,288 20.4%

4 Yokukansan 3,984 30.5%

5 Kamishoyosan 3,653 4.7%

6 Goshajinkigan 3,531 2.7%

7 Bakumondoto 3,510 14.3%

8 Saireito 3,336 -0.5%

9 Shakuyakukanzoto 3,309 7.5%y ,

10 Shoseiryuto 2,757 13.6%Total of 129 prescriptions of Tsumura 89 247 6 5%p pprescription Kampo formulations 89,247 6.5%

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Trends of Cost of Sales Ratio, Ratio of Selling, General and Administrative Expenses, and Operating Margin (Consolidated)

Cost of sales ratio

55 958.4

60.160

Ratio of selling, general and administrative expensesOperating margin%

49 450.050.750.8

54.655.154.355.2

53.5

55.9

50

32 233.3

32 332 7

35.034.2

37.938.845.246.2

47.849.4

40

31.531.131.432.232.331.031.332.7

31.4 31.2

20 822.7 23.3

30

18.2

13.714.312.2

9 911.5

14.117.0 16.7

18.320.8

20

9.9

1.0

3.910

Plan

01997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

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Major New Facilities for Production of Kampo Preparations Planned Expansion/ Start of Operation

S h d l f C t ti f N P d ti F iliti

FY2009 FY2010 FY2011

Schedule of Construction of New Production Facilities

Powdered extract production process at Ibaraki

Operations to commence in FY2011

Operations toGranulation process at Ibaraki Operations to commence in FY2012

Granulation and packaging processes at Shizuoka

Operations to commence in FY2014processes at Shizuoka commence in FY2014

Powdered extract production process at Shanghai

Operations to commence in FY2013

Storage of crude drug, etc.(Ishioka, Shenzhen, Yubari etc.)

Operations to commence in FY2011 -

FY2013

Powdered extract production capacity (per year)

FY2009 FY2011 FY2013

3,300t +750t (4,050t)at Ibaraki Plant

+700t (4,750t)at Shanghai Plantat Ibaraki Plant at Shanghai Plant

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Establishing Kampo Medicine - 1

As of March 31, 2011

Progress in Kampo medicine education

Providing at least 8 compulsoryProviding at least 8 compulsoryKampo courses

Kampo clinics for outpatients

FD: Systems for training lecturers organized by medical schools

78 medical schools

79 medical schools

g y

79 medical schools

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Establishing Kampo Medicine - 2

Medical Education Model Core Curriculum

First curriculum revision in 10 years

Medical Education Model Core Curriculum(Ministry of Education, Culture, Sports, Science and Technology)

(Partial revision in December 2007)March 2001

(2010 Revised Version)March 2011

F Basics of medical care F Basics of medical care2 Basic knowledge on medical care(1) Fundamental principle of

pharmacological treatmentAttainment target:

2 Basic knowledge on medical care(1) Fundamental principle of

pharmacological treatmentAttainment target:

17) Capable of giving outlines of Wakan-yaku, traditional Japanese medicine.

17) Capable of giving outlines on characteristics and reality of use of Wakan-yaku, traditional Japanese

di i (K ti )medicine (Kampo preparations).

Excerpt from Medical Education Model Core CurriculumExcerpt from Medical Education Model Core Curriculum –Guidelines on Content of Education-Year 2010 Version

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Promoting Drug FosteringSteady progress since the start in FY2004Steady progress since the start in FY2004

Double blind tests (DBT) started for all Double blind tests (DBT) started for all drug fostering formulas based on past drug fostering formulas based on past

Steady progress since the start in FY2004Steady progress since the start in FY2004

g gg gachievementsachievements

FY2011DBT for five formulasDBT for five formulas

FY2009Addition of two formulas (3+2)

FY2009

Drug fostering started (3 formulas)FY2004

“Drug fostering” refers to the processes of examining the recent structure of diseases, focusing on disorders that are difficult to treat with

modern drugs but for which Kampo preparations have shown specific results in areasmodern drugs but for which Kampo preparations have shown specific results in areas where medical needs are heavy, and establishing evidence (scientific basis) for them.

35

Expansion of Drug-Fostering Formulas (Fields)

FY2004 FY2009

Gastroenterological medicineSurgery

Goshajinkigan

CancersRikkunshitoDaikenchuto +DaikenchutoGoshajinkigan

Neuropsychiatry

Yokukansan

HangeshashintoDaikenchutoRikkunshitoYokukansan

- Accumulation of more reliable evidence

- Facilities such as medical school hospitals playing the key roley

- Use of scientific research fund (Ministry of Health, Labour and industry) for some of the research

36

Implementation of DBT for Drug FosteringFormul Name of research,

Representative institution, Number of FY2009 FY2010 FY2011 FY2012 FY2013

a No,

etc.,

number of institutions, etc.

cases as entries Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Colon Team(Clinical Pharmacology)Target: 400 cases

Kitasato UniversityApprox. 50institutions

317 cases(61 cases)

3/2011Jan. 2009 – Jun. 2011

TJ-100

DKTForum

Target: 400 cases

Hepatic Surgery TeamTarget: 200 cases

Kushiro RosaiHospitalApprox. 20institutions

214 cases3/2011

Stomach and Oita University 11

Feb. 2010 – Jan. 2012

Stomach and Esophagus Team Target: 240 cases

Oita UniversityApprox. 30institutions

11 cases3/2011

TJ-43 FDTarget: 430 cases

Keio UniversityScientific research fund

-

Jan. 2011 – Dec. 2012

Feb. 2011 – Sept. 2012

TJ-54

Schizophrenia Target: 120 cases

Shimane UniversityScientific research fund

-

BPSDTarget: 140 cases

Tohoku UniversityScientific research fund

-

Mar. 2011 – Feb. 2012

Feb. 2011 – Mar. 2013Analysis:

Oct.

fund

TJ-107

GONETarget: 80 cases

Asahikawa Medical University -

GENIUSTarget: 310 cases

Kyushu UniversityScientific research fund

- Oct. 2010 – Mar. 2013

May 2009 – Oct. 2010

TJ-14

Hangesya-CTarget: 90 cases

Osaka NationalHospital -

Hangesya-GTarget: 90 cases

Kanagawa Cancer Center - Oct. 2010 – Sept. 2012

Oct. 2010 – Sept. 2012

- FD: Functional dyspepsia- GERD: Gastroesophageal reflux disease- BPSD: Behavioral and Psychological

Symptoms of Dementia

- DBT: Double Blind Test- TJ-100: From the Japanese Foundation for Multidisciplinary

Treatment of Cancer (JFMC)- Others: From UMIN Clinical Trials Registry 37

Presentations on Kampo in DDW

DDW: Digestive Disease Week in the United States

FY Site Number of presentations Contents

2011 Chicago 21 Rikkunshito: 16 (Basic)Daikenchuto: 5 (Basic)Rikkunshito: 14 (Basic: 8 Clinical: 6)

2010 New Orleans 21Rikkunshito: 14 (Basic: 8, Clinical: 6)Daikenchuto: 6 (Basic: 3, Clinical: 3)Shakuyakukanzoto: 1 (Clinical)Rikk hit 10 (B i 7 Cli i l 3)2009 Chicago 13 Rikkunshito: 10 (Basic: 7, Clinical: 3)Daikenchuto: 3 (Basic)

2008 San Diego 8 Rikkunshito: 8 (Basic: 5, Clinical: 3)

2007 Washington D.C. 3 Rikkunshito: 2 (Basic)

Daikenchuto: 1 (Basic)

38