AMR Benchmark Opportunities: progress update

Research-based pharmaceutical company

Otsuka Pharmaceutical Co, Ltd
This table is part of a November 2023 report that looks at what actions each company in scope of the AntimicrobialResistance (AMR) Benchmark has taken with regards to each of the Opportunities set out in its 2021 AMR Benchmark
Report Card. The full 2021 Report Card is also included in this PDF.

2021 O PPO RTU N IT Y

2023 U PDATE

What was the Opportunity shared in the AMR Benchmark?

What progress has been made on this Opportunity?

Expand breadth of R&D pipeline into more pathogens.

Otsuka did not report progress on this Opportunity, refer-

Despite being the smallest of the large R&D-based com-ring to its current focus on tuberculosis (TB) R&D.

panies assessed in the AMR Benchmark, Otsuka optimises
its resources and has achieved remarkable expertise intuberculosis R&D, being one of the main investors in TB
R&D worldwide. Otsuka can now redirect this expertise andinvest in innovative in-house R&D to target resistant pathogens for which R&D is limited, such as Campylobacter spp.
and H. pylori, through acquisition or collaboration with othercompanies, or by joining existing public private partnerships.
Develop an AMR-specific environmental risk-Otsuka reports that it has completed the development ofmanagement strategy and increase public disclosure.

an analytical method to quantify the levels of delamanid

Otsuka reports a commitment to manufacture its products

in wastewater. As a follow-up, Otsuka plans to quantify

in an environmentally responsible manner without specify-discharge levels to confirm if the existing wastewatering whether AMR is taken into account. The company cantreatment setup maintains delamanid concentration below

develop an AMR strategy for its own manufacturing sites,discharge limits.

the sites of suppliers and external private waste-treatment
plants, based on the guidelines of the AMR Industry Alliance,of which Otsuka is a member. This includes setting limits
and quantifying discharge levels to track compliance.
Moreover, Otsuka can publish information on how it manages environmental risk related to antibacterial manufacturing to curb AMR.
Ensure availability and affordability of delamanid

Otsuka reports that since 2021, Deltyba® is newly regis-(Deltyba).

tered in three countries in scope of the Benchmark – Brazil,

Otsuka can expand the availability of delamanid (Deltyba)

Morocco and Uzbekistan. Additionally, Otsuka has also filed

by filing for registration in more access countries, including

for registration in four countries in scope – Malaysia, Mexico,

through its voluntary licensing agreement with Viatris, inThailand and Vietnam. To increase affordability and accessi-

particular in the 30 countries with the highest MDR-TB

bility, Otsuka has completed a full technology transfer for its

burden identified by the WHO.

50mg delamanid formulation to Viatris in India. In addition,
Otsuka has initiated a technology transfer of delamanid’s
paediatric formulation. Furthermore, Otsuka reports acommitment to ensure a continuous supply of delamanid’s
paediatric formulation to the Stop TB Partnership’s Global
Drug Facility (GDF).

Engage in AMR surveillance activities.

Otsuka reports plans to set up surveillance activities in at

Otsuka is not active in AMR surveillance activities. It canleast two countries in scope. However, Otsuka does notengage in AMR surveillance programmes through setting

report when these surveillance activities will commence.

up (in-house) programmes or by funding establishedThe company reports that future surveillance results will be

programmes run by research organisations. Additionally,submitted for publication in open access journals.

Otsuka should publicly share raw data collected from theprogramme.

19Antimicrobial Resistance Benchmark 2021

OPC

Overall Performance
2020

2021

52 % 57% ▲Access to Medicine Foundation

Otsuka Pharmaceutical Co, Ltd
Large R&D-based pharmaceutical company
Stock exchange: TSE • Ticker: 4578 • HQ: Tokyo, Japan • Employees: 5,657

OPCPERFORMANCE
Otsuka performs average overall in its evaluated Research Areas

Performance in the Benchmark

0%compared to the other large research-based pharmaceutical companies
in scope.
R&D: Otsuka performs well in R&D. All four projects in its pipeline
are antibacterial medicines: three targeting M. tuberculosis and one
targeting a critical and/or urgent pathogen (P. aeruginosa). It has one
novel antituberculosis candidate in clinical development. Otsuka has two
projects in late-stage development with comprehensive plans for accessenvironmental risk-management strategy but without a specific aim to(on-patent medicine) for registration in access countries. Reports somestrategies to expand access and ensure continuous supply of its relevant
product.
Stewardship: Middle-performing. It does not promote delamanid(Deltyba®) to healthcare professionals which is its only product in50%

100%

Points56%

R&D

14/ 25

43%

Manufacturing

6/ 1460%

Access

9/ 15

65%

Stewardship0%

13/ 2050%

100%

How Otsuka was evaluatedlimit AMR.
Appropriate Access: Middle-performing. Files its relevant products

42/ 74

Performance by Research Areaand stewardship.
Responsible Manufacturing: Performs low. Reports a general

Points57%

Overall score

A R&D

12.1 2.2 2.3 2.43

●

●

●

●

123

B Manufacturing ●

●

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3C Access●●●4567C Stewardship

●

●

●

●

●

●

●

●

scope. It is not involved in AMR surveillance programmes. It reports
comprehensive conflict of interest mitigation for its educational
programme. It adapts brochures for patients.

● ● ● Scored●

Not scoredOPPORTUNITIES FOR OTSUKA

CHANGES SINCE 2020

Expand breadth of R&D pipeline into more pathogens. Despite being the smallest of the large• In February 2020, Otsuka joined the Project to

R&D-based companies assessed in the AMR Benchmark, Otsuka optimizes its resources and has

Accelerate New Treatments for Tuberculosis

achieved remarkable expertise in tuberculosis R&D, being one of the main investors in TB R&D(PAN-TB), a collaboration among philan-worldwide. Otsuka can now redirect this expertise and invest in innovative in-house R&D to target

thropic, non-profit and private sectors part-resistant pathogens for which R&D is limited, such as Campylobacter spp. and H. pylori, throughners that aims to develop an investigational

acquisition or collaboration with other companies, or by joining existing public private partnerships.

drug regimen capable of treating all forms ofDevelop an AMR-specific environmental risk-management strategy and increase public disclo-TB.

sure. Otsuka reports a commitment to manufacture its products in an environmentally responsible• In September 2020, the European Medicinesmanner without specifying whether AMR is taken into account. The company can develop an AMR

Agency (EMA) approved the extension ofstrategy for its own manufacturing sites, the sites of suppliers and external private waste-treat-

Otsuka’s MDR-TB treatment delamanid

ment plants, based on the guidelines of the AMR Industry Alliance, of which Otsuka is a member.

(Deltyba®) to include children with a bodyThis includes setting limits and quantifying discharge levels to track compliance. Moreover, Otsuka

weight of at least 30 kg. In July 2021, the EMA

can publish information on how it manages environmental risk related to antibacterial manufactur-

approved the use of the 25 mg dispersible

ing to curb AMR.

tablet formulation of delamanid (Deltyba®) forEnsure availability and affordability of delamanid (Deltyba®). Otsuka can expand the availability ofthe treatment of pulmonary MDR-TB in adults,

delamanid (Deltyba®) by filing for registration in more access countries, including through its vol-adolescents, children and infants with a bodyuntary licensing agreement with Viatris, in particular in the 30 countries with the highest MDR-TB

weight of at least 10 kg.

burden identified by the WHO.
Engage in AMR surveillance activities. Otsuka is not active in AMR surveillance activities. It canengage in AMR surveillance programmes through setting up (in-house) programmes or by funding
established programmes run by research organisations. Additionally, Otsuka should publicly shareraw data collected from the programme.

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Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONS

OPC
Revenue by business segment

Therapeutic areas: Cardiovascular and renal diseases, Central nervous

2019

system, Oncology, Ophthalmology, Tuberculosis

2020

Business segments: Pharmaceuticals

924,250
955,1590

Product categories: Innovative medicines

200,000

400,000

600,000

800,000

Pharmaceuticals

M&A since 2020: None in the antibacterial and/or antifungal sectors

1,000,000
mn JPY

OPC
Revenue by region
2019

450,2132020

436,8120

200,000

400,000

JapanNorth America

Others289,335

184,701

335,396
600,000

182,949

800,000

1,000,000
mn JPYPIPELINE for pathogens in scope

PORTFOLIO for pathogens in scope

Pipeline size: 4 projects targeting pathogens in scope* (4 antibacterial

Comparatively small portfolio: At least 1 product: 1 antibacterial medicinemedicines).

On-patent medicine: 1 (delamanid)

Development stages: 1 clinical project, OPC-167832, a Phase II candidate

AWaRe medicines: 0for the treatment of M. tuberculosis; and 1 preclinical project targeting P.

Anti-TB medicine**: 1aeruginosa.
Novelty: 1 novel project, OPC-167832, an antituberculosis candidate thatOPC
Pipeline for priority pathogens

meets all four criteria set by WHO for innovativeness.
‘Critical’ and/or ‘urgent’ pathogens: 1 project, VIS705, a preclinical therapeutic candidate, targeting P. aeruginosa, including MDR strains.

401020Regulatory approvals: 2 approvals. Marketing authorisation by the EMA
was granted to the antituberculosis drug delamanid (Deltyba®) for thetreatment of children with a body weight of at least 30 kg. In July 2021 theEMA approved the use of the 25 mg dispersible tablet formulation of delamanid (Deltyba®) for the treatment of pulmonary MDR-TB in adults, adolescents, children and infants with a body weight of at least 10 kg.

● Antibacterial vaccine● Antibacterial medicine● Antifungal vaccine● Antifungal medicine

OPC
Products on the market
0101020● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

PERFORMANCE BY RESEARCH AREAA

RESEARCH & DEVELOPMENT Evaluated: medicine & vaccine pipelines for priority* bacteria & fungi

A.1

Investments in R&D

pathogens in scope. All of them are medicines

cine candidate which meets all four WHO’s inno-

Otsuka discloses to the Benchmark its R&D

targeting bacterial pathogens: three are antitu-vativeness criteria: OPC-167832. In September

investments during 2019 and 2020 in antibac-

berculosis agents and the remaining one tar-

2020, EMA approved the extension of Otsuka’s

terial and antifungal medicines and/or vaccines

gets P. aeruginosa. Out of the four projects, one

MDR-TB treatment delamanid (Deltyba®) tofor pathogens in scope. Otsuka reports that it

is in preclinical stage, one in Phase II, delamanid

include children with a body weight of at least

invested USD 34.61 mn in R&D for antibacte-(Deltyba®) for paediatric patients received mar-30 kg. In July 2021, the EMA approved the use ofrial medicines in 2019 and 2020. This constitutes

keting approval during the period of analysis andthe 25 mg dispersible tablet formulation of dela-a small proportion of its revenues compared tothe adult indication remains in Phase IV.

manid (Deltyba®) for the treatment of pulmo-

the other companies who reported investmentsnary MDR-TB in adults, adolescents, children andA.2.2 Small innovative pipelineto the Benchmark.

infants with a body weight of at least 10 kg.

Otsuka’s clinical-stage medicine pipeline conA.2.1 Pipeline targets mainly M. tuberculosis

sists of both innovative and adaptive R&D pro-

A.2.3 Not active in vaccine development

The company reports four projects targeting

jects. Otsuka has one antituberculosis medi-Otsuka is not active in vaccine development tar-

Pipeline targeting priority pathogens: 4*** As at 24 September 2021
DiscoveryPre-clinical
VIS705 [P. aeruginosa]

Phase I

Phase II
OPC-167832 [M. tuberculosis]

Phase III

Approval
Delamanid (Deltyba®)[M. tuberculosis][EMA/Sep-20] additional population: paediatric (>30 kg)[EMA/Jul-21] additional
formulation (25mg)(>10 kg)†*** Includes 1 Phase IV project not shown in the figure.
† Approved after the end of the period of analysis.
* See Appendix V for information about
eligibility for R&D projects and Appendix
VII for eligibility criteria of products.
** Listed on the 2019 WHO EML.

19

Antimicrobial Resistance Benchmark 2021

geting pathogens in scope.

Access to Medicine Foundation

Otsuka has two medicine projects in late-stageensure its appropriate use, as well as availability

development. For its project OPC-167832, inand affordability in access countries†.

Phase II, Otsuka has committed itself conA.2.4

One candidate targeting criticaltractually to a comprehensive access strat-

and/or urgent priorities

egy as stipulated by the Bill & Melinda Gates

Otsuka has one medicine candidate in its R&D

Foundation. Otsuka also reports plans to engage

pipeline targeting pathogens defined as ‘critical’in surveillance and monitoring of the emer-

by WHO’s list of priority pathogens and/or char-gence of resistance to this new antituberculo-

acterised as ‘urgent’ threats by the US Centers

sis candidate.

for Disease Control and Prevention (CDC).

For the paediatric indication of the antitu-VIS705 is in preclinical development and targets

berculosis drug delamanid (Deltyba®) forP. aeruginosa, including MDR strains.

which marketing authorisation by the EMA was
granted in September 2020 for children above

A.3

Comprehensive planning for access and30 kg and on July 2021 for children above 10 kg,stewardship

Otsuka also has comprehensive strategies toB

RESPONSIBLE MANUFACTURING Evaluated: antibacterials manufacturing (APIs and drug products)

B.1

No AMR-specific environmental risk

B.2Publicly discloses some information on

subsuppliers of antibacterials. The Benchmark

environmental risk managementfound no requests for official corrective action

Otsuka’s general environmental strategy

Otsuka publishes some components of its envi-

from the FDA or EMA related to non-conform-

includes a commitment to manufacture its prod-ronmental risk-management strategy, with-ities with cGMP at Otsuka’s own sites or any

ucts in an environmentally responsible mannerout specific references to AMR. It is a member

subsidiaries.

but without a specific aim to limit AMR. Its strat-of the AMR Industry Alliance, which publishes aegy also does not include any actions specific tolist of recommended antibacterial discharge tar-delamanid (Deltyba®), the only antibacterial pro-gets. Otsuka does not publish: (1) the results ofduced at its manufacturing sites, in both its API

environmental audits, whether conducted at itsand drug product forms.

own sites, the sites of suppliers or external pri-management strategy

Otsuka does not report making any require-vate and public waste-treatment plants; (2) a listments in this regard to the third-party drugof these suppliers and plants; or (3) the levels of

product manufacturer contracted for an inter-antibacterial discharge from its own or suppli-

mediate step in delamanid production.

ers’ sites.

There is also limited information on therequirements Otsuka makes of external private

B.3

System in place to maintain production
quality for own and suppliers’ sites; nowaste-treatment plants, in terms of strategy,

requests for official corrective action

audits and discharge limits and levels. It reports
these plants are audited every three years but

Otsuka reports that its own sites and suppliers

audit parameters are not related to AMR. It also

have a system to maintain high-quality antibac-

reports wastewater is treated on-site and exter-

terial production consistent with international

nal private and public wastewater treatment

GMP standards. This includes periodic risk-based

plants are not used.

audits and tracking of corrective and preventive actions. Otsuka reports it does not have anyCAPPROPRIATE ACCESS & STEWARDSHIP – ACCESS

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries†
Otsuka is not eligible for indicators: C.1.2, C.1.3,of USD 1,700 for a 6-month treatment course.

data sharing by conducting long-term plan-

C.2.2 and C.2.3. For more information, see

Otsuka has a voluntary licensing agreement withning and S&OP planning. Otsuka mitigates

Appendix VII.

Viatris and R-Pharm to accelerate access toagainst shortage risks by keeping a 1,5-year aver-delamanid (Deltyba®) in high TB burden coun-age buffer stock in the countries where dela-

Filed to register its on-patent medicine

tries. Otsuka and Viatris have entered into amanid (Deltyba®) has a marketing authorisa-in 9 access countries

technology transfer agreement, to produce andtion. It conducts annual inventory checks andOtsuka has an average performance, filing its

distribute a lower-cost generic version of dela-

external audits of its stocks. Otsuka conducts

one on-patent medicine for registration in nine

manid (Deltyba®). Otsuka provides evidence

a technology transfer to allow Viatris to man-access countries. The medicine is the anti-tuber-of patient reach and geographic reach for its

ufacture, package, and distribute delamanid

culosis medicine, delamanid (Deltyba®).

reported approaches. It estimates that at least(Deltyba®) in a set of access countries. To mit-

24,700 treatment courses were distributed inigate against substandard and falsified prod-

2020. Delamanid (Deltyba®) is available in all 30

ucts, Otsuka uses security features such as seri-

WHO high-burden countries for MDR-TB.

alisation, GS1 barcodes and GDSN traceability.

C.1.1

C.2.1 Some strategies to expand access to its
on-patent medicine
Otsuka has an average performance. It aims toexpands access to its one on-patent medicine inaccess countries through a voluntary licensing

Delamanid (Deltyba®) has a unique packaging
C.3

Some strategies to ensure continuous

process including alu-alu blisters, tamper-proof

supplyseals, and unique identifier codes.

agreement and a partnership. It partners with

Otsuka has an average performance, with

the Global Drug Facility - Stop TB Partnershipstrategies reported in all four areas assessed.

to provide delamanid at a global access price

Otsuka ensures accurate demand planning and† 102 low- and middle-income countries
where better access to medicine is mostneeded.

20

Antimicrobial Resistance Benchmark 2021

CAccess to Medicine Foundation

APPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globallyC.4

Comprehensive COI mitigation strategies

healthcare professionals, the company is not eli-in place for its educational programme

gible to be assessed on marketing materials.

Otsuka performs strongly in conflict of interest (COI) mitigation for the one AMR-related

C.6

Makes one type of brochure and/or
packaging adaptation to facilitate appro-

educational programme for HCPs assessed

priate use by patientsby the Benchmark. The programme has all
three COI mitigation strategies looked for by

Otsuka adapts brochures to facilitate the appro-

the Benchmark: (1) content is developed inde-

priate use of delamanid (Deltyba®) by patients.

pendently from its marketing department; (2) a

Otsuka is middle-performing in this measure,pledge not to provide financial or material incen-

taking account of language. It has translated

tives to participants; and (3) it does not use

its Educational Risk Minimisation Materials into

branded materials.

English, French, Spanish and Russian, which are
distributed through the Global Drug Facility.

C.5

Does not promote its antibacterial
medicine

Otsuka performs strongly in sales practices as it

C.7

No involvement in AMR surveillance
programmes

does not promote its product in scope. It does

Otsuka is the only large R&D-based company

not deploy any sales agents to promote dela-that does not report any involvement in AMR

manid (Deltyba®) to healthcare professionals,

surveillance programmes.

because treatment is only available in specialised
centres under tightly controlled conditions. Since
Otsuka does not develop or use marketing materials for delamanid (Deltyba®) to promote it to21