2 ★ FINANCIAL TIMES Tuesday 27 August 2019

Médecins Sans Frontières aid agency,

says the area is too densely populated

and the population too mobile for the

ring strategy to work. “Ring vaccination

is not a terrible strategy, in and of itself,

but the dynamics of this epidemic mean

thatitisnotfeasible,”shesays.

Stocks of the vaccine are also limited.

Onlyaboutanother350,000dosesofthe

Merck shot will be available this year,

accordingtotheWHO.

In response, health professionals,

including MSF, have been calling for a

second trial using a vaccine under

development at Johnson & Johnson. Up

to 1.5m doses could be deployed, but in

July, Oly Ilunga, the then DRC minister

ofhealth,blockeditsuse.

A new programme could undermine

fragile trust in the current Merck opera-

tion, Dr Ilunga said. He added that the

J&J vaccine, which requires two shots 57

days apart, was less advanced and could

bemoredifficulttomanage.

Peter Piot, director of the London

School of Hygiene and Tropical Medi-

cine and co-discoverer of the Ebola

virus, says he was shocked by the deci-

sion.

The British medical school is part of a

consortium that had been working with

the Congolese government on a second

trial. He says the J&J vaccine has per-

formed well in animal testing and could

be used to vaccinate a much wider seg-

mentofthepopulation.

“Because there is a limited supply, we

have to make sure that every vaccine is

used in the best possible way,” he says. It

is only through trials during outbreaks

thatnewonescanbeproven,headds.

A shift in policy could yet see the J&J

vaccine deployed. Researchers

launched a trial in Uganda in August,

while Jean-Jacques Muyembe, the

respected virologist leading the

response in Congo, has proposed using

the J&J product to vaccinate cross- bor-

dertradersinregionalcapitalGoma.

At the mortuary in Beni, where as

many as five bodies continue to arrive

each day, the staff have no knowledge of

the debate over vaccination strategies.

Theyjustwantittoend.

Nearly 2,000 people have been killed

so far in what is the longest and deadli-

est outbreak in the country’s history.

Everydaymoregrievingrelativesarrive

toidentifytheirlovedones.

“This disease must just stop so we can

return to normal life,” says Marcel

Mbafumoja, a burial team member, as

yet another bereaved family files up the

mortuary’s stone ramp. “We can’t keep

livinglikethis.”

Continuedfrompage

FT HealthCommunicable Diseases

Contributors

Clive Cookson

Science editor

Richard Hatchett

Chief executive of the Coalition for

Epidemic Preparedness Innovations

Andrew Jack

Global education editor

Hannah Kuchler

US pharma and biotech correspondent

Sarah Murray

Freelance journalist

Shigeru Omi

President of the Japan Community

Health Care Organisation

Tom Wilson

East Africa correspondent

Darren Dodd

Commissioning editor

Steven Bird

Designer

Esan Swan

Picture editor

For advertising details, contact:

Ian Edwards, +44 (0) 207 873 3272,

[email protected], or your usual FT

representative.

All editorial content in this report is

produced by the FT. Our advertisers have

no influence over or prior sight of articles.

Vaccine

debate dogs

Ebola

response

I

nnovation knows no boundaries. A

project to develop a treatment for a

debilitating tropical disease in Afri-

can children is blending Japanese

pharmaceutical expertise with

longstanding German knowledge, sup-

plemented by insights from academics

inEurope,LatinAmericaandAfrica.

For years the medicine praziquantel

has been used as the best treatment for

— and prevention method against —

schistosomiasis (bilharzia), an inflam-

matory disease transmitted by parasitic

worms. Yet the infection’s concentra-

tioninsomeofthepoorestandremotest

parts of the world means there has been

little financial incentive to stimulate

research.

The result was that until recently, the

effects of the drug in small children —

among those most at risk — had never

been systematically tested. But in the

past five years, an international consor-

tium has been working to understand

the best dosage and formulation to

make it safe, effective and palatable for

the pre-school age group. The work

includes support from Japanese phar-

maceutical company Astellas on paedi-

atric formulation and clinical develop-

mentinchildren.

The project — which is scheduled to

achieveregulatoryapprovalin2021—is

oneofthemostadvancedinthepipeline

for the Global Health Innovative Tech-

nology Fund, a Tokyo-based non-profit

vehicle.

Over this decade, GHIT has forged

partnerships between a growing

number of Japanese companies and

their commercial and academic coun-

terparts around the world to accelerate

efforts to tackle neglected diseases in

low-incomecountries.

With support from the Japanese gov-

ernment, the UNDP and philanthro-

pists including the Wellcome Trust and

the Bill & Melinda Gates Foundation, it

aims to break down silos between

organisations and engage Japanese

researchersinglobalconsortiums.

“This is a poster child of the GHIT

fundingmechanismcomingtofruition,”

says Catherine Ohura, recently

appointed as chief executive at

the fund, which has provided nearly

$16m to support the consortium.

Since its launch in 2013, GHIT has

allocated a total of $170m to 80 partner-

ships to develop drugs, diagnostics and

vaccines — with each such project

involving Japanese companies or aca-

demic institutions working alongside

internationalpartners.

Japanese companies have long been

active in identifying agents and devel-

oping drugs to tackle communicable

diseases, including antivirals, anti-

fungals, anti-parasitics and more than

100anti-bacterialagents.

They have also made significant

progress over the past 10 years in esca-

lating work on neglected tropical dis-

eases, specifically targeting patients in

low-incomesettingsand,throughGHIT,

workingwithexternalpartners.

Eisai, one of the Japanese pharma

groups, was distinctive in working on

NTDs in the build-up to the 2012 “Lon-

don Declaration”, an agreement by

pharmaceutical companies to work

togethertoendsuchdiseases.

Astellas and Takeda were among the

groups that pledged support soon after,

and Daiichi Sankyo has also since begun

work in the field. Today, Eisai has sev-

eralprojectsinthepipeline.

The result is that in the most recent

Access to Medicines Index, produced by

a research organisation in the Nether-

lands, Takeda advanced sharply from

15th to fifth among the top global phar-

maceutical companies, while Eisai

jumpedfrom11thtoeighth.

Takeda, run since 2015 by Christophe

Weber, a French national, has devel-

oped initiatives including equitable

pricing, waiving patents on products in

low-income countries, and a strategy on

access to healthcare, which is overseen

directlybythechiefexecutive.

Eisai’s high score reflected its exten-

sive focus on research and development

in priority areas and its commitment to

donations and strong ethical standards,

for its own sales representatives as well

asforthirdparties.

“We have seen that Japanese compa-

nies in particular have embraced the

idea of measuring and reporting access

programmes,” says Prof Richard Laing

at the Boston University School of Pub-

lic Health, who oversees a new Access

Observatory of public information on

accesstomedicine.

Yet such initiatives can only function

once new products have been success-

fully developed. One issue for GHIT and

the other groups it works with is the

slow and uncertain pace of testing and

developmentforsafetyandefficacy.

Ms Ohura, a veteran of commercial

drug companies, argues: “If anything,

I’m quite surprised to see that GHIT

scores a little higher on the probability

of success [on getting drugs approved]

comparedtomyexperience.”

She stresses the organisation’s capac-

ity in “connecting the dots and creating

the pathway” for research and develop-

ment,whichremainsitscoremission.

But she concedes that even when

GHIT projects succeed, there is an addi-

tional barrier in using those products to

target neglected diseases: how to pro-

vide access and deliver them to those in

need in the absence of a significant mar-

ket, well-developed medical infrastruc-

tureorthecapacitytopay.

“Getting drugs and diagnostics

approved is one thing,” she says. “Get-

tingthemtopatientsisanother.Thereis

a lot of complexity in access, which

includes regulation and World Health

Organizationguidelines.

“Plus how we can make the financing

achievable and lower the cost of manu-

facturing,”sheadds.

Her organisation and others have had

some success but ensuring widespread

access for new drugs for the poor

remainsaworkinprogress.

Japanese tie-ups catalyse research

Tokyo-based fund forges

links between Japanese

health companies and

global partners, writes

Andrew Jack

Japaneseuniversitiesandcompanies

areadeptatcreatingsolutionsto

combatinfectiousdiseases,suchas

malaria,tuberculosisandHIV.Yetwith

sofewJapaneseaffected,thecountry’s

researchersfinditdifficulttoforge

aheadwithclinicaltrials.

Withthisinmind,theJapan

CommunityHealthcareOrganizationis

workingwithresearchinstitutionsin

south-eastAsiaandelsewheretocreate

aframeworkfortrialsinthecountries

hithardestbythesediseases.

WehaveaskedtheJapanese

governmentfor¥6bnover10years,as

wellasdiplomaticsupport, tohelpset

upthenewplatform.Wehopetesthubs

forTBandmalariacanbeginworkin

2020.

Malaria-relatedtrialswillberunout

ofThailand’sMahidolUniversityanda

TBcentrewillbebasedinIndonesia.

Thenewprocesswillcarryouttests

onnewmedicines,vaccinesorother

medicalproducts,undertake

epidemiologicalstudiesandworkwith

theinternationalresearchnetworkset

upbytheTokyo-basedNationalCenter

forGlobalHealthandMedicinein2016.

Theproject’s“commandcentre”in

Japanwillconsistofanexecutive

councilmadeupofexpertsfrom

industry,thegovernmentand

academia;scientificcouncilsfor

individualdiseases,suchasTB,malaria

anddenguefever;andasecretariat,

basedattheNationalInstitutesof

BiomedicalInnovation,Healthand

Nutrition.

Theexecutivecouncilandthe

scientificcouncils,eachwitharound

members,willmeetafewtimesayearto

decidewhen,whereandwhatnew

productswillbetested.

Westerncountrieshaveledthewayin

thistypeoftrialprocess.SouthAfrica’s

UniversityofCapeTown,forexample,is

aleaderontrialsforTBvaccinesand

epidemiologicalresearch.Italso

undertakestrialscommissionedby

businesses—apracticethatishelping

theinstitutionbecomefinancially

independent.Wehopethatthiskindof

mechanismwillhaveasimilareffectin

Japan.

Japanesecompaniesanduniversities

finditdifficulttogetaccesstoforeign

marketsforclinicaltrialswherewestern

playersaredominant.Ifwedonot

addressthis,westernbusinessesand

universitieswilldominatethe

developmentandsaleofnewmedical

productsforinfectiousdiseasesacross

theworld.

Japanese-ledtrialscanbringmany

benefits.Theywilllettherestofthe

worldprofitfromJapaneseinnovation,

allowthecountry’smanufacturersto

tapemergingmarketsandenhance

Japan’spresenceintheinternational

community.TheywillalsobenefitJapan

inthefaceofgrowingrisksofdiseases

suchasdenguefeverandmalaria

transmittedbytravellersfromChina,

south-eastAsiaandSouthAsia.

ShigeruOmiispresidentoftheJapan

CommunityHealthCareOrganization

Clinical trials venture

aims to challenge

western domination

OPINION

Shigeru

Omi

‘Getting

drugs and

diagnostics

approved is

one thing.

Getting

them to

patients is

another’

Praziquantel,

shown above

being

administered to

a child in

Madagascar, is a

key drug in in

the fight against

schistosomiasis

GHIT chief executive Catherine Ohura

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