GHIT Fund
ANNUAL REPORT

2015

E

W E

A R E

E X P A N D I N G.
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A R E

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G R O U N D.
W E

W I L LD E L I V E R.

01

CONTENTS
AN UNYIELDING ETHOS

03

WE WILL DELIVER

05

OUR PORTFOLIO

07

WE ARE ON THE GROUND

09

NEW PARTNERS, NEW PROMISE

11EXPANDING GLOBAL NETWORK13PRIVATE-SECTOR ENGAGEMENT

15

FINANCES

17

LEADERSHIP

19
02

AN UNYIELDING ETHOSLetter from Chair and CEO
We are pleased to report noteworthy progress, from theearly research in Japan on the river blindness drug Ivermectin

frontiers of discovery to the frontlines of global health, as a

refocused attention on global health R&D. Ivermectin

result of our work.

transformed hundreds of millions of lives and communities,
and the story of its development represents the power of

We are expanding: our portfolio and partners are morediverse and driven than ever.

private-public collaboration, as well as Japan’s legacy of

We are on the ground: clinical trials in high-burdencountries are under way for many of our invested
innovations.

Despite the success of Ivermectin and numerous other global

We will deliver: critically needed innovations steadily
moving through our pipeline will be delivered to patients.

scientific excellence and creativity.

health innovations, extraordinary disease burdens persist in lowand middle-income countries. But we are optimists. We believethat the next game-changing global health tools are withinreach. To deliver on the promise of innovation, our work

The 2015 Nobel Prize awarded to Dr. Satoshi Omura for his
03

de-risks the global health product development process byFrom left: Masafumi Nogimori (Representative Director and Chairman, Astellas Pharma Inc.), Haruo Naito (Representative Corporate Officer and CEO, Eisai Co., Ltd.), Isao Teshirogi (President andCEO, Shionogi & Co., Ltd.), Trevor Mundel (President, Global Health, Bill & Melinda Gates Foundation), Yasuchika Hasegawa (Chairman of the Board, Takeda Pharmaceutical Company Limited),
George Nakayama (Representative Director, President and CEO, Daiichi Sankyo Company, Limited), Mitsuhiro Ushio (Assistant Minister for Global Health, Ministry of Health, Labour and Welfare),Kiyoshi Kurokawa (Representative Director and Chair, GHIT Fund), Atsuyuki Oike (Director-General for Global Issues, Ministry of Foreign Affairs), BT Slingsby (CEO, GHIT Fund), Hiroyuki
Yamaya (Director, Office of International Cooperation, Ministry of Health, Labour and Welfare), Eiji Hinoshita (Director, Global Health Policy Division, International Cooperation Bureau, Ministry ofForeign Affairs), Hikaru Ishiguro, (Board Member, Health and Global Policy Institute), Peter Piot (Director and Professor of Global Health, London School of Hygiene and Tropical Medicine),
Ko-Yung Tung (Senior Counselor, Morrison & Foerster) (Affiliation and title are as of June 5, 2015.) Not pictured: Mahima Datla (Managing Director, Biological E. Limited), Ann Veneman (Former
Executive Director, UNICEF; Former Secretary, United States Department of Agriculture), Kim C. Bush (Director, Life Sciences Partnerships, Bill & Melinda Gates Foundation) and Richard Seabrook(Head, Business Development, Wellcome Trust).

facilitating meaningful R&D partnerships between Japan andcandidates that do show promise.

the world, by helping each sector contribute strengths andcapabilities to accelerate global health innovation.

The creativity, insight, and commitment of our funders,sponsors, and product development partners inspire ourOur role is not simply to reduce the financial burden of

approach and propel our impact. We offer our gratitude andglobal health R&D. Success also depends on how welook forward to continued work together toward a healthier,manage our portfolio of investments, which for us means

more prosperous world.

leveraging the principles of product development used in
the private sector for public purposes. In this we areunyielding: we do not accept mediocre results. Too many
lives are at stake to pursue candidates that do not showpromise. The goal is to keep the valuable time andresources of people and institutions focused on the

Kiyoshi Kurokawa, MD
Board Chair

BT Slingsby, MD, PhD, MPH
Chief Executive Officer04

WE WILL DELIVER
Since our recent launch, we have built a robust portfolio of

million. Our Development Partners are more diverse thandrugs, vaccines, and diagnostics and effectively tapped into

ever–36 based in Japan, 41 outside Japan, shifting theJapan’s cutting-edge science and technology platforms for

fundamental approach to global health R&D in Japan andglobal health. But success for us is not simply showing thataround the world.

our model works in terms of governance, portfolio
management, or leveraging Japanese know-how for global

In just three years, GHIT and its Development Partners have

health. Rather, success means patients can access ouridentified 18 hit series and seven preclinical candidates;

effective, affordable products.

initiated seven clinical trials for novel candidates; and had
one clinical candidate achieve Proof of Concept (POC,

GHIT has invested in more than 60 product development

Phase II). This progress is the direct result of our productpartnerships, with allocations totaling more than US$60

development partners’ strong leadership and commitment to

STAGE
GATE

LEAD OPTGO

PRECLINICALGO

Lead Optimization

PHASE IGO

Preclinical Development

PHASE IIGO

Phase I

Eisai Co., Ltd., Liverpool School of Tropical Medicine, University of Liverpool (Lymphatic filariasis and Onchocerciasis)
Eisai Co., Ltd., Broad Institute (Malaria)
Takeda Pharmaceutical Company Limited, DNDi (Leishmaniasis)

PZQ: Praziquantel Consortium (Astellas Pharma Inc., Farmanguinhos, Lygature,
Merck KGaA, Simcyp Limited, Swiss Tropical and Public Health Institute) (Schistosomiasis)
DSM265: Takeda Pharmaceutical Company Limited,
Medicines for Malaria Venture (Malaria)

Drugs
Eisai Co., Ltd., Liverpool School of Tropical Medicine,
University of Liverpool (Malaria)(+)-SJ733: Eisai Co., Ltd., Medicines for Malaria Venture, St. Jude Children’s Research Hospital (Malaria)
Ajinomoto Co., Inc., Meiji Seika Pharma Co., Ltd., University of Massachusetts Medical School, PATH (Soil-transmitted helminthiasis)
GeneDesign, Inc, DNDi (Leishmaniasis)

National Institutes of Biomedical Innovation, Health and Nutrition, Create Vaccine, Aeras (Tuberculosis)

BK-SE36/CpG: Research Institute for Microbial Diseases,
Osaka University, Gulu University (Malaria)

Eisai Co., Ltd., Aeras, Baylor College of Medicine,
Sabin Vaccine Institute (Chagas disease)
The Chemo-Sero-Therapeutic Research Institute, Mahidol University (Dengue)
BK-SE36: RIMD, Osaka University,
Centre National de Recherche et de Formation sur le Paludisme,
European Vaccine Initiative (Malaria)

Vaccines

Institute of Tropical Medicine (NEKKEN) Nagasaki University, Institut Pasteur, European Vaccine Initiative (Dengue)
Institute of Tropical Medicine (NEKKEN) Nagasaki University, McGill University, The Ohio State University (Leishmaniasis)

Product Design

Product Development

Graduate School of Agricultural and Life Sciences, University of Tokyo, National Research Center for Protozoan Diseases,
Obihiro University of Agriculture and Veterinary Medicine, InBios International, Inc., University of the Philippines (Schistosomiasis)

Diagnostics

FUJIFILM Corporation, Foundation for Innovative New Diagnostics (Tuberculosis)
Institute of Tropical Medicine (NEKKEN) Nagasaki University , Juntendo University, Malaria No More Japan (MNMJ),
National Institute of Advanced Industrial Science and Technology, Panasonic Corporation, Kenya Medical Research Institute (KEMRI) (Malaria)

05

achieving each potential product’s exit strategy.
One important reason I support GHIT is its effective
Such dedication means that critically needed innovations

engagement of Japanese pharmaceutical companies;

with the potential to save millions of lives are now no

involvement in and contributions to global health activities

longer just aspirations; they are moving steadily through thecarry great benefits. Product development is very difficult,pipeline.

and some important and potentially game-changing
contributions from the companies that participate in GHIT
are their chemical libraries for research for new drugs, as

We will deliver.

well as their very talented scientists.

Bill Gates
Co-chair, Bill & Melinda Gates Foundation

PHASE IIIGO

POC

Phase II

18
7
7
1

LICENSEGO

Phase III

Registration

E1224: Eisai Co., Ltd., DNDi (Chagas disease)

Hit Series
Identified

Preclinical Candidates
Identified

DAR-901: Tokyo Medical and Dental University, Geisel School of Medicine at Dartmouth,
Muhimbili University of Health and Allied Sciences (Tuberculosis)

Product Validation

FY2013 Invested

Clinical Candidates
Identified

Registration

FY2014 Invested

FY2015 Invested

Advanced

Planned

Proof of Concept
Achieved

06

OUR PORTFOLIO
Discovery
Target Research Platform

Screening Platform

Drug

Drug

Drug

Diagnostic

Drug

Drug

Drug

Drug

Drug

Drug

Drug

Drug

Drug

Drug

Malaria

Tuberculosis

Chagas disease/Leishmaniasis

NTDs

Drug

Drug

Drug

Drug

Drug

90.0
USD

USD

GHIT Total
Committed Investment– Leveraged

MillionGHIT Investment

31.7
Million( USD )

70.0

29.6
Million

60.0
50.0

USD

20.6
Million

40.0
USD

USD

USD

USD 2.0
MillionUSD 6.6
Million

19.0
Million

USD

34.3
Million2013 September

2014 March2014 September

46.1
Million

57.2
Million

USD

63.7
Million

30.0
20.0
10.0

2015 March

2015 September

2016 MarchThe US dollar amounts represent translations of Japanese yen, solely for the reader’s convenience, at JPY 100 = USD 1.

07

80.0

USD

USD

12.8
Million

32.3
Million0

Cumulative investments USD (in millions)96

Co-investment

Preclinical

ClinicalHit-to-Lead Platform

Product Development Platform

Product Development Platform

Drug

Drug

Vaccine

Drug

Drug

Vaccine

Drug

Drug

Diagnostic

Drug
UNIVERSITYOF FLORIDA

Vaccine

Drug

Drug

VaccineVaccineDrug

Diagnostic

Drug

Chagas disease
Drug

Vaccine

Drug

Drug

Dengue fever
VaccineVaccineLeishmaniasis
Drug

Drug

VaccineLymphatic filariasis/Onchocerciasis
Drug

Schistosomiasis
Diagnostic

Drug

Soil-transmitted helminths
Drug

For more details of each project, please visit the GHIT Fund Website. https://www.ghitfund.org/impact/portfolio/advance08

WE ARE ON THE GROUND
Six potential global health products currently being

developed over the next few years, could make an immense

advanced with GHIT investment are on the ground, in theimpact on the lives and livelihood of millions worldwide, as

clinic, reaching patients and persons who live in areas where

well as a lasting effect on their communities, societies andmalaria, tuberculosis, Chagas disease, and schistosomiasis

economies.

are endemic. These six potential products if successfully

PERU
DSM265 Malaria/Drug

BOLIVIAE1224 Chagas disease/Drug

DSM265

E1224

DSM265 kills the malaria parasite throughinhibition of an essential enzyme. The
compound’s long duration of action
creates the potential for DSM265 tosupport acute treatment, as well as be partof a single-dose cure. DSM265 hascompleted a Phase IIa Proof of Concept
study in patients with uncomplicated P.
falciparum or P. vivax malaria in Peru.
This project aims to develop a commercial
formulation of DSM265 prior to phase IIb
clinical trials.

Just two existing drugs, discovered decades ago, havevariable efficacy in treatment of the chronic phase of Chagas
disease and an unsatisfactory tolerability profile in adults.
This Phase IIa trial tests E1224, which, with similar or
improved efficacy but a better tolerability profile, particularly
in adults, paves the way for a breakthrough. Eisai and DNDi
joined efforts to conduct a Phase II, proof-of-concept study ofthe combination of E1224, a new-generation triazole
compound with potent inhibitory activity against ergosterol
biosynthesis, and the reference drug, Benznidazole, instandard and reduced dosing regimens, to provide a newtreatment strategy for Chagas disease. In preparation for
future registration, all required chemistry, manufacturing, andcontrols activities and nonclinical tests will be conducted.

Disease: Malaria
Intervention: Drug
Development Stage: Phase IIb
Country: Peru

09

Disease: Chagas disease
Intervention: Drug
Development Stage: Phase IIa
Country: Bolivia

6Countries

BURKINA FASO
BK-SE36 Malaria/VaccineUGANDA

BK-SE36/CpG Malaria/Vaccine

IVORY COASTPZQ Schistosomiasis/Pediatric Drug

TANZANIA
DAR-901 TB/Vaccine

PZQ

Disease: Schistosomiasis
Intervention: Pediatric Drug
Development Stage: Phase IIa
Country: Ivory Coast
With praziquantel, the standard recommended treatment
for schistosomiasis, younger children run a significant riskof choking because of the size and bitter taste of the oral
tablets. The new pediatric praziquantel candidates aremuch smaller, can be dispersed in water, have improved
taste, as compared with the current tablets and canwithstand the challenges presented by a tropical climate. A
Phase II clinical trial in Ivory Coast is currently ongoing totest these new candidates in preschool-age children,
infants, and toddlers in order to identify the formulationand dose with the best efficacy/safety profile in thesechildren. The resulting clinical data will enable registrationof the selected formulation in endemic countries where themedication is urgently needed.

DAR-901

Disease: Tuberculosis
Intervention: Vaccine
Development Stage: Phase IIb
Country: Tanzania
An inactivated whole cell TB vaccine booster isthe only new TB vaccine in development to haveshown efficacy in humans. The current versionof this vaccine, DAR-901, has been shown to
produce an immune response in adults who
received childhood BCG (the current TB
vaccine) in a Phase 1 study. This new Phase 2
proof-of-concept study in Tanzania tests whether
DAR-901 prevents initial TB infection when
given as a booster to 13-to-15-year-old
adolescents who received BCG at birth. Thisapproach contrasts with most TB vaccine trials
that test whether a vaccine prevents the laterstage of active TB disease.

BK-SE36
BK-SE36/CpG
Disease: Malaria
Intervention: Vaccine
Development Stage: Phase Ia/Ib
Country: Burkina Faso, Uganda
The BK-SE36 malaria vaccine candidate
Phase Ia clinical compares results withdata from a previous clinical trial
conducted in Uganda (where slightly
different malaria disease characteristics
were noted), tests the vaccine candidate
in children one to five years old who
have thus far not been included in
testing, and generates additional
information on safety, immunogenicity,and efficacy.

10NEW PARTNERS,NEW PRO MISE
We launched the GHIT Fund in 2013 as a $100 million fund.

Our expansion process has accelerated, and we are honored to

Today, as a result of new and renewed commitments, ourwelcome additional commitments from multiple new partners:

funding exceeds $140 million. In 2015, GHIT welcomed the

FUJIFILM Corporation, GlaxoSmithKline, Johnson & Johnson,

Wellcome Trust as a Full Partner and, Sysmex Corporation as

Kyowa Hakko Kirin Co., Ltd., Merck KGaA, Mitsubishi

an Associate Partner, and All Nippon Airways Co., Ltd.,

Tanabe Pharma Corporation, Nipro Corporation, Otsuka

Morrison & Foerster LLP, and Yahoo Japan Corporation

Pharmaceutical Co., Ltd., and Sumitomo Dainippon Pharma

joined us as Sponsors. Our Full, Associate, and AffiliateCo., Ltd. We are also very happy to welcome salesforce.com

Partners contribute funds that expand our global health R&D

Co.,Ltd. as a new Sponsor. These Partners’ and Sponsors’

investment capacity. In-kind legal, communication, and travel

engagement demonstrates their commitment to transforming

contributions from our Sponsors allow us to reduce our

global health R&D; their contribution broaden our reach andoperational costs and maintain a 5% overhead rate.

increase the impact and efficiency of our work.

2013

Partners

Sponsor2014
Partner

2015

Partners

Sponsors

2016

Partners

Sponsor= Founding Partner*Organizations listed under each year represent new partners and sponsor as of that year.
These new partners and sponsors join the larger group of organizations listed under previous
years--organizations that remain partners and sponsors today.

11The Ebola crisis reinforced for us both the urgent need for global health innovation how effectively
industry and the global health community can mobilize together to create and deliver new solutions.
Partnering with the GHIT Fund helps us engage even more meaningfully in global health over the longterm and enables us to leverage our history of innovation.

Shigetaka Komori
Chairman and CEO
FUJIFILM Corporation

Otsuka Pharmaceutical, based on our corporate philosophy of ‘Otsuka-people creating new products for better healthworldwide’, and on our scope as a total healthcare company, focuses on the creation of uniquely innovative products that
address people’s unmet medical needs that arise from pressing global healthcare problems. Our commitment to develop newtreatments for tuberculosis, led to investments for over thirty years in basic and clinical research that resulted in the creationof delamanid, one of the first new anti-tuberculosis agents in almost half a century. Henceforth, through our participation in
the GHIT Fund, it is our sincere belief that we can contribute further to improving the health of people across the world.

Tatsuo Higuchi

President and Representative Director
Otsuka Pharmaceutical Co., Ltd.

We are dedicated to providing innovative and effective pharmaceutical solutions to people not only inJapan but also around the world through research and development of new drugs. Participation in the GHIT
Fund helps us be more globally active and bring our leading-edge technologies to fight against infectious
diseases in the developing world.

Masayo Tada

Representative Director, President and CEO
Sumitomo Dainippon Pharma Co., Ltd.

The Ebola crisis served as a stark reminder of the devastating potential of infectious diseases. But whenthat epidemic finally subsides, there remains countless other infections threatening the health of theworld’s poorest populations. By partnering with GHIT, the Wellcome Trust hopes to bring the very best ofJapanese science to bear in tackling this critical unmet need.

Stephen Caddick

Director of the Innovations divisionWellcome Trust

Globalization has connected populations around the world in unprecedented ways. It has also increased therisk of infectious diseases spreading around the globe. We believe it is ANA’s social responsibility tosupport the GHIT Fund.

Osamu Shinobe
President and CEO
ANA

12EXPANDING GLOBALNETWORK

University of Liverpool
Liverpool School of Tropical Medicine
Simcyp Limited
PATH
InBios International, Inc.

Ohio State University
St. Jude Children’s Research Hospital
Baylor College of Medicine

McGill University

Institut Pasteur

Lygature
Merck KGaA

Broad Institute
Trustees of Dartmouth College Geisel School of Medicine
University of Massachusetts
Global Alliance for TB Drug Development
Aeras
PATH Malaria Vaccine Initiative
Sabin Vaccine Institute

University of Florida

Centre National de Recherche et deFormation sur le Paludisme
Université Félix-Houphouët-Boigny(PZQ Consortium’s local partner)

Asociación Civil Selva Amazónica
(MMV’s local partner)

Universidad Mayor de San Simon*
Universidad Autònoma Juan Misael Saracho*
Collective of Applied Studies and Social Development*
Platform of Integral Care for Patients with Chagas Disease*

Farmanguinhos（*DNDi’s local partners)

18 36 41
Countries

13

Japanese
Organizations

Non-Japanese
Organizations

European Vaccine Initiative

Ajinomoto Co., Inc.
Astellas Pharma Inc.
CellFree Sciences Co., Ltd.
Create Vaccine Co., Ltd.
Chugai Pharmaceutical Co., Ltd.
Daiichi Sankyo Company, Limited
Daiichi Sankyo RD Novare Co., Ltd.
Ehime University
Eisai Co., Ltd.
Fujifilm Corporation
GeneDesign, Inc.
Hokkaido University
HyphaGenesis Inc.
Institute of Tropical Medicine,(NEKKEN), Nagasaki University
Institute of Microbial Chemistry
Japan BCG Laboratory
Juntendo University
The Kitasato InstituteMalaria No More Japan

Medical Center for Translational Research, Osaka University
Meiji Seika Pharma Co., Ltd.
Mitsubishi Tanabe Pharma Corporation
National Institute of Advanced Industrial Science and Technology
National Institutes of Biomedical Innovation, Health and Nutrition
Obihiro University of Agriculture and Veterinary Medicine
OP Bio Factory Co., Ltd.
Panasonic Corporation
RIMD, Osaka University
Shionogi & Co., Ltd.
Sumitomo Dainippon Pharma Co., Ltd.
Takeda Pharmaceutical Company Limited
The Chemo-Sero-Therapeutic Research Institute
The Research Institute of Tuberculosis, Japan Anti-Tuberculosis
Association
University of Tokyo
Tokyo Medical and Dental University
Toyama Prefectural University

Swiss Tropical and Public Health InstituteDrugs for Neglected Diseases initiative
Foundation for Innovative New Diagnostics
Medicines for Malaria Venture

Mahidol University

University of the Philippines

Gulu University
The Kenya Medical Research InstituteMuhimbili University of Health and Allied Sciences
Ifakara Health Institute(PZQ Consortium’s local partner)

64

The University of Melbourne
Walter and Eliza Hall InstitutePartnerships
Funded* Continuation projects included

14

PRIVATE - SECTORENGAGEMENT
Japanese pharmaceutical companies—critical GHIT

markets of the future, as well as in their product portfolios.

partners—have become progressively more engaged on

The CEOs of these companies have led the charge,

global issues. This engagement is manifested in theircommitting their companies to tangible global health R&D

policies and priorities, which increasingly recognize thepartnerships through the GHIT Fund.

importance of access and affordability in reaching theFrequent air travel associated with globalization is likely to increase
the risk of health issues like infectious diseases occurring in one
geographic region to spread across the globe and impact worldwide
health. Developing medicines to mitigate these types of risks is our
mission. However, this problem is too big to be addressed by only one
company. We are dedicated to conducting global health activities thatleverage our know-how regarding development and formulation
technologies by working in close cooperation withgovernments, academia, and NPOs.

Japan has invested in infrastructure in low- and middle-income
countries through ODA. Once infrastructure is developed and basic
needs are met, the next priority is improving health. Japan is one of
the top leaders in the pharmaceutical arena and has the uniquecapacity and technology to contribute to the developing world beyond
ODA. The GHIT Fund offers an exceptional vehicle not only for
private-sector engagement in global health R&D, but also for thereinforcement of Japan’s national reputation andleadership on the global stage.

Yoshihiko Hatanaka

Isao Teshirogi, PhD

Chugai, a leader in biotechnology-based pharmaceuticals, is enthusiastic
about leveraging its technical prowess to conduct research and development
activities in the battle against the dengue virus. Asia bears a large share of
the burden from dengue, and attention is growing in Japan as well.
Therefore, Chugai will work diligently to help create a single treatment
effective against all four serotypes of the dengue virus. Good medicines
have the potential to strengthen tomorrow’s workforce by improving healthoutcomes, and thus enabling the emergence of a middle class that can playa central role in the economic life of a country. One issue that remains,
however, is finding ways to link the population growth in Asia with thelong-term prosperity of the entire global economy.

In the past, R&D for malaria and NTDs was not considered to be “goodbusiness” because of the enormous associated costs and risk. For thosereasons, it has also been difficult for a single company to conduct such
drug development on its own. Few pharmaceutical products reach themarket, despite new discoveries and rapid technological advancements. In
that sense, modern drug development is similar to gold mining. However,at the same time, we also gain knowledge and insights through eachproduct’s development process. We at Daiichi Sankyo are enthusiastic
about contributing to global health by utilizing our accumulated expertiseto help develop new and innovative products
for the people around the world who need them.

Osamu Nagayama

George Nakayama

Eisai signed a joint statement with WHO in 2010, in which it committed
to supply WHO with 2.2 billion tablets of its diethylcarbamazine (DEC)to combat lymphatic filariasis free of charge. Distribution began in 2013.
Furthermore, Eisai is a GHIT Fund investee for Chagas disease drug
development. Our motivation is to help people across the globe overcome
disease and engage in economic activities, contributing to national income
and national wealth. Investments in fighting infectious disease represent a
long-term investment in future market growth. Addressing global healthhas a potential to create a virtuous cycle with better
economic prospects—for Japan and the world alike.

New malaria drugs are needed to fight drug resistance. We haveworked with Medicines for Malaria Venture on the development of anew, long-acting malaria drug as part of the effort to eradicate
malaria, and received a US $2.5 million grant from the GHIT Fund. I
think the GHIT Fund’s network of partners, including governments,
pharmaceutical companies, and academics, is an effective approach
for infectious diseases. It enables us to access tremendously valuable
chemical libraries that we do not possess,
as well as important partners on the ground.

Haruo Naito

Christophe Weber

President and CEO
Astellas Pharma Inc.

Representative Director, Chairman and CEO
Chugai Pharmaceutical Co., Ltd.

Representative Corporate Officer and CEO
Eisai Co., Ltd.

15

President and CEO
Shionogi & Co., Ltd.

Representative Director, President and CEO
Daiichi Sankyo Company, Limited

Representative Director, President and CEO
Takeda Pharmaceutical Company Limited

16

FINANCES***For Translation Purposes Only***

Independent Auditor’s Report
To the Board of Directors, Global Health Innovative Technology Fund:<Audit of the Financial Statements>
We have audited the accompanying financial statements, which comprise the balance sheet, the statement ofincome, the notes to the financial statements, and the related supplementary schedules of the Public Interest
Incorporated Association Global Health Innovative Technology Fund (“the Organization”) applicable to thefourth fiscal year from April 1, 2015, through March 31, 2016. We conducted our audit in accordance withthe rules and regulations concerning the Act on the Authorization, etc. of Public Interest Incorporated
Associations and Public Interest Incorporated Foundations in Japan, under Article 23.
Directors’ Responsibility for the Financial Statements and the Related Supplementary Schedules
Directors need to ensure that the financial statements and related supplementary schedules were prepared andfairly presented in accordance with accounting principles generally accepted in Japan. Among others,
directors are responsible for designing and operating such internal control as directors determine is necessary
to enable the preparation and fair presentation of the financial statements and the related supplementaryschedules that are free from material misstatement, whether due to fraud or error.
Auditor’s Responsibility
Our responsibility is to express an opinion on these financial statements and the related supplementaryschedules based on our audit. We conducted our audit in accordance with auditing standards generally
accepted in Japan. Those standards require that we plan and perform the audit to obtain reasonable assurance
about whether the financial statements and the related supplementary schedules are free from material
misstatement.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in thefinancial statements and the related supplementary schedules. The procedures selected depend on theauditor’s judgment, including the assessment of the risks of material misstatement of the financial statements
and the related supplementary schedules, whether due to fraud or error. The purpose of an audit of thefinancial statements is not to express an opinion on the effectiveness of the Organization’s internal control,
but in making these risk assessments, the auditor considers internal controls relevant to the Organization’s
preparation and fair presentation of the financial statements in order to design audit procedures that areappropriate for the circumstances. An audit also includes evaluating the appropriateness of accounting
policies used and the reasonableness of accounting estimates made by directors, as well as evaluating theoverall presentation of the financial statements and the related supplementary schedules.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our
audit opinion.
OpinionIn our opinion, the financial statements and the related supplementary schedules referred to above present
fairly, in all material respects, the financial position and results of operations of the Organization applicableto the fourth fiscal year ended March 31, 2016, in conformity with accounting principles generally acceptedin Japan for Public Interest Incorporated Associations (similar to a 501(c)(3) in the United States).
<Opinion on the List of Assets and Liabilities>
We have audited the accompanying list of assets and liabilities for the fourth fiscal year of the Public Interest
Incorporated Association Global Health Innovative Technology Fund at March 31, 2016. We conducted our
audit in accordance with the rules and regulations concerning the Act on the Authorization, etc. of Public
Interest Incorporated Associations and Public Interest Incorporated Foundations in Japan, under Article 23.
Directors’ Responsibility for the List of Assets and Liabilities
Directors need to ensure that the list of assets and liabilities was prepared and fairly presented in accordancewith accounting principles generally accepted in Japan and also in conformity with the public-interest
certification documents.

17***For Translation Purposes Only***

Auditor’s Responsibility
Our responsibility is to express an opinion on the said list of assets and liabilities which was prepared andfairly presented in accordance with auditing standards generally accepted in Japan and also in conformity
with the public-interest certification documents.
OpinionIn our opinion, the list of assets and liabilities referred to above present fairly, in all material respects, inaccordance with auditing standards generally accepted in Japan and also in conformity with the
public-interest certification documents.
<Conflicts of Interest>
We have no interest in the Organization which should be disclosed in compliance with the Certified Public
Accountants Act.

Ernst & Young ShinNihon LLC
May 9, 2016
End-of-Document

2015 Financial Summary (Audited)
ASSETS, LIABILITIES, AND NET ASSETS
Millions ofYenMillions of
U.S. Dollars

FUNDS RECEIVED

Millions ofYenMillions of
U.S. Dollars

Cash and Cash Equivalents
Fixed Assets¥ 289.9
2,015.6

$ 2.6
17.9

¥ 1,219.4$10.8

TOTAL ASSETS¥ 2,305.5$ 20.5Governments, NGOs,
Multilateral Organizations
Foundations
Corporations

1,420.5
600.0

12.6
5.3

TOTAL FUNDS RECEIVED¥ 3,239.9$ 28.7ASSETSLIABILITIES AND NET ASSETS

Millions ofYenMillions of
U.S. Dollars¥ 370.9$ 3.3

Total Liabilities
Net Assets

1,934.6

17.2

TOTAL LIABILITIES AND NET ASSETS¥ 2,305.5$ 20.5FUNDS RECEIVED
37.6% Governments, NGOs,
Multilateral Organizations
43.9% Foundations
18.5% Corporations

NET ASSETS VARIATION STATEMENT
Millions ofYenMillions of
U.S. Dollars

Governments, NGOs,
Multilateral Organizations
Foundations
Corporations¥ 1,219.4

$10.8

977.7
346.9

8.7
3.1

TOTAL ALLOCATED REVENUE¥ 2,544.0$ 22.6EXPENSES

Millions ofYenMillions of
U.S. Dollars

Program Services
Support Services¥ 2,394.0$21.3

TOTAL EXPENSES¥ 2,517.0

ALLOCATED REVENUECARRY-OVER FROM PRIOR YEAR

¥0

123.0

SOURCES OF
ALLOCATED REVENUE
47.8% Governments, NGOs,
Multilateral Organizations
38.5% Foundations
13.7% Corporations

$0

1.1

$22.4

EXPENSE ALLOCATION
95.1% Program Services
4.9% Support Services

The US dollar amounts in this section represent translations of Japanese yen, solely for the reader’s convenience, at JPY 112.62 = USD 1, the approximate
exchange rate on March 31, 2016.
This financial summary is an excerpt from the GHIT Fund’s audited financial statements, which are audited by Ernst & Young ShinNihon LLC. The GHIT Fundis a Pubic Interest Incorporated Association and is registered in Japan.
18

LEADERSHIPOur governance structure is designed to structurally transcend

development and delivery of products to patients. Companies

potential conflicts of interest that can arise when a company may

commit non-dilutive capital to the GHIT Fund but thenbe both a benefactor and a beneficiary of the Fund. The reason

relinquish all decision making for investments and portfolio

for this is simple: national institutes and universities are criticalmanagement to a Board and Management Team that excludes

research partners, but we need companies to champion theprivate-sector representation.

COUNCIL[Roles and Function] Appoint and dismiss members of the Council and Board/ Amend Articles of Incorporation/ Determine Board terms/ Serve as advocates for the Fund/Approve financial statements

Koichi Aiboshi

Naoko Yamamoto, MD, MPH, PhD

Trevor Mundel, MD, PhD

Astellas Pharma Inc.

Chugai Pharmaceutical Co., Ltd.

Daiichi Sankyo Company, Limited

Eisai Co., Ltd.

Shionogi & Co., Ltd.

Takeda Pharmaceutical
Company Limited

Director-General for Global Issues,
Ministry of Foreign Affairs

Yoshihiko Hatanaka
Representative Director,
President and CEO

Haruo Naito
Representative Corporate Officer
and CEO

Assistant Minister for Global Health,
Minister’s Secretariat,
Ministry of Health, Labour and Welfare

Osamu Nagayama
Representative Director,
Chairman and CEO

Isao Teshirogi, PhD
President and CEO

President, Global Health,Bill & Melinda Gates Foundation

George Nakayama
Representative Director,
President and CEO

Christophe Weber
Representative Director,
President and CEO

BOARD OF DIRECTORS[Roles and Function] Approve midterm strategies/ Approve annual plans and budget/ Appoint and dismiss Selection Committee members/ Approve selection criteria andpriorities for the Selection Committee/ Approve investment recommendations from the Selection Committee

Representative Director and Chair

Vice Chair

Executive Director

Adjunct Professor,
National Graduate Institute for
Policy Studies & Chairman,
Health and Global Policy Institute

Director and Professor of Global Health,London School of Hygiene and Tropical Medicine,
Former Executive Director, UNAIDS

CEO,
Global Health Innovative Technology Fund

Kiyoshi Kurokawa, MD

BT Slingsby, MD, PhD, MPH

MemberMemberMemberManaging Director,
Biological E. Limited

Director, Global Health Policy Division,
International Cooperation Bureau,
Ministry of Foreign Affairs

Former Executive Director, UNICEF
Former Secretary,
United States Department of Agriculture

Mahima Datla

Eiji Hinoshita, MD, PhD

Ann M. Veneman, JD

MemberSupervisory Board Member

Supervisory Board Member

Director, Office of International
Cooperation, Ministry of Health,Labour and Welfare

Board Member,
Health and Global Policy InstituteSenior Counselor, Morrison & Foerster
Former Senior Vice President
and General Counsel of the World Bank

Hiroyuki Yamaya

Hikaru Ishiguro, LLM

Ex-Officio Observer

Ex-Officio Observer

Director, Life Sciences Partnerships,
Bill & Melinda Gates Foundation

Head, Business Development, Innovations,
Wellcome Trust

Kim C. Bush

19

Peter Piot, MD, PhD

Richard Seabrook, PhD, MBA

Ko-Yung Tung, JD

SELECTION COMMITTEE[Roles and Function] Review and evaluate investment proposals and progress reports from development partners/ Recommend provision of investments to the Board based on theirevaluations/ Ensure independence, accountability, and transparency of investment recommendations

MemberMemberMemberHead, Seeding Drug Discovery Fund,Business Development, Innovations,
Wellcome Trust

Deputy Director,
Discovery & Translational Sciences,
Bill & Melinda Gates Foundation

Project Professor, Nagoya City University
Visiting Lecturer, United Centers for Advanced
Research and Translational Medicine,
Tohoku University Graduate School of Medicine

Ann Mills-Duggan, PhD

Ken Duncan, PhD

Kouji Hattori, PhD

MemberMemberMemberDirector, Vaccine Development
and Surveillance,
Bill & Melinda Gates Foundation

Professor and Dean,
Nagasaki University School of
Tropical Medicine and Global Health

Chief Scientific Officer,
Vela Diagnostics

Penny M. Heaton, MD, MPH

Kiyoshi Kita, PhD

Gerd Michel, PhD

MemberMemberMemberProfessor, Division of Clinical Virology,
Center for Infectious Diseases,
Kobe University Graduate School of Medicine

Former Head, Infectious Diseases Research,
Merck Research Labs, USA,
Former Head, Research, MSD-Japan

Technical Officer, Malaria, other Vectorborne
and Parasitic Diseases Unit, Division ofCommunicable Diseases, World HealthOrganization Western Pacific Regional Office

Yasuko Mori, MD, PhD

Dennis Schmatz, PhD

Aya Yajima, MSc, PhD

ADVISORY PANEL[Roles and Function] Provide strategic advice to the Fund's Board Chair, CEO, and Management Team

MemberMemberMember

Minister of Health, Republic of Senegal
Former Executive Director,
Roll Back Malaria Partnership

President, Gordon and Betty Moore Foundation
Former President,
Institute of Medicine of the National Academies

Senior Director, Health Technologies
Pharmaceutical and Health Technologies GroupManagement Sciences for Health

Awa Marie Coll Seck, MD, PhD

Harvey V. Fineberg, MD, PhD

Dai Hozumi, MD, MSM, MPH

MemberMemberMemberTaro Takemi Professor,
International Health Policy,
Harvard School of Public HealthPresident and CEO,
Cosmo Public Relations Corporation

Former Director, Department of
Neglected Tropical Diseases, WHO

Michael R. Reich, PhD

Kumi Sato

Lorenzo Savioli, MD, DTM&H, MSc

MemberPeter Singer, MD, MPH, FRCPCCEO,Grand Challenges Canada

20

LEADERSHIP
EXTERNAL REVIEWERS
The work of the GHIT community could not progress without vital support from these experts and their institutions worldwide.

21

Akinori Kimura

Giuseppe Pantaleo

Nadia Tourniporth

Sanjay Jain

Alan Fairlamb

Gray Heppner

Nancy Le Cam Bouveret

Sanjeev Krishna

Ami Shah Brown

Greg Matlashewski

Naoto Keicho

Shigeyuki Kano

Ann Ginsberg

Herman Feldmeier

Nathalie Strub-Wourgaft

Shing Chang

Birgitte Giersing

Hidehito Kotani

Niranjan Kanesa-thasan

Simon Campbell

Brian Greenwood

Hing Sham

Nisha Garg

Simon Croft

Bruce G. Weniger

Hiroyoshi Endo

Pantaleo Giuseppe

Somei Kojima

Carl Mendel

James Le Duc

Paul Kaye

Stephen Johnston

Carol Marzetta

James Mckerrow

Paul Roepe

Stephen Ward

Carole A. Long

JoAnne L. Flynn

Paul Wyatt

Sue KinnCharles Mgone

Judy SakanariPeter Andersen

Takafumi Tsuboi

Charles Mowbray

Kaoru Terashima

Peter Dailey

Takashi Fujitsu

Christine Debouck

Katsushi Tokunaga

Peter G. Kremsner

Takushi Kaneko

Clifton E Barry

Kent Kester

Peter John Myler

Thierry Diagana

Dan Stinchcomb

KJ Singh

Peter RuminskiThomas Dick

Daniel E. Goldberg

Lee HallPeter Smith

Timothy K. Lu

Daniel Neafsey

Lewellys F. Barker

Philip Russell

Timothy Wells

David A Fiddock

Lynn Soong

Polly Roy

Toshihiro HoriiDavid Brown

Marcel Tanner

Punnee Pitisuttithum

Walt Brandt

David Pompliano

Marleen Boelaert

R.Kiplin Guy

Yoshihisa Hashiguchi

Dennis Kyle

Meg Phillips

Rebecca Richards Kortum

Yukihiro Akeda

Donato Zipeto

Michael Free

Regina Rabinovich

Yves Ribeill

Elizabeth Winzeler

Michael Kurilla

Ricardo T Gazzinelli

Zarifah Reed

Eric Chatelain

Michael Witty

Richard Adegbola

Filip Dubovsky

Mickey Urdea

Rino Rappuoli

Gerd Michel

Moriya Tsuji

Sanjay Gurunathan

PARTNERS
Full Partners

Associate Partners

Affiliate Partners

Sponsors

22

Ark Hills Sengokuyama Mori Tower 25F,
1-9-10 Roppongi, Minato-ku,
Tokyo 106-0032 Japan
TEL: +81-36441-2032 FAX: +81-36441-2031
www.ghitfund.org