AMR Benchmark Opportunities: progress update

Research-based pharmaceutical company

Johnson & Johnson
This table is part of a November 2023 report that looks at what actions each company in scope of the Antimicrobial
Resistance (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?

Diversify access plans for late-stage R&D projects.

Clinical trials for the ExPEC9V vaccine candidate areJohnson & Johnson has one medicine and one vaccine inactively recruiting participants, including in two low- andlate-stage development. It can improve access to these new

middle-income countries (LMICs): China and Thailand.

products, by developing plans for registration, affordability

In October 2023, Johnson & Johnson announced a devel-and sustainable supply. For example, for their phase III vac-

opment and commercialisation agreement with Sanofi forcine, ExPEC9V, Johnson & Johnson can define the accessthe candidate. It is too early for the companies to disclose

countries where they will file for registration, based on bur-access plans for the ExPEC9V vaccine candidate.

den of disease, and where it considers ability-to-pay in its
pricing strategy. Johnson & Johnson can also engage withexternal partners with the expertise to help boost availability of the vaccine in relevant territories once approved.
Ensure compliance with antibacterial discharge limits

Johnson & Johnson continues to report implementing theat own sites and suppliers by tracking and publicly

AMR Industry Alliance’s Antibiotic Manufacturing Standard.

disclosing progress and results.

However, based on public information, it is unclear how

Johnson & Johnson reports to set limits and to quantify

many of its own and supplier sites are compliant withthe discharge levels at its own sites and suppliers’ sites.

discharge limits.

To provide clear evidence of its progress, it can track

Similar to 2021, Johnson & Johnson does not publicly

compliance at all sites and publicly disclose the results.

disclose individual audit results containing antibacterial

Disclosure of information, including the results of audits anddischarge levels for both its own sites and suppliers’ sites.

antibacterial discharge levels of its own sites and suppliers’

Furthermore, the company does not disclose the names andsites, is important. It can also publicly disclose the names

locations of its suppliers.

and locations of its suppliers and waste-treatment plants forincreased transparency.
Expand reach of bedaquiline (Sirturo) for eligible

Johnson & Johnson continues to expand access to

MDR-TB patients.

bedaquiline (Sirturo®) for multidrug-resistant tuberculosis

Johnson & Johnson has continued to reach more patients(MDR-TB) patients. By the end of 2020, Johnson & Johnsonwith MDR-TB through tenders, patient assistance pro-

had provided more than 317,000 courses of bedaquiline

grammes, access price settings and public or private part-

cumulatively to patients in 144 countries, including all 30

nerships. It can further apply these mechanisms to expand

high-burden MDR-TB countries. By September 2023, thisaccess and ensure diagnosed patients are treated, especiallynumber has more than doubled to a total of 745,000 courses

in countries where gaps remain between diagnosis ofof bedaquiline, provided to patients in 159 countries, includ-

MDR-TB and treatment.

ing all 30 high-burden MDR-TB countries. Three out of four
MDR-TB patients on treatment globally are receiving all-oral
bedaquiline-containing regimens. The majority of bedaquiline
courses have been supplied via the supranational agreementwith the Stop TB Partnership’s Global Drug Facility (GDF).
In 2023, there were three key developments affecting
access to bedaquiline in LMICs. 1) In June 2023, Johnson &Johnson granted GDF appropriate licences which allows GDF
to purchase generic versions of bedaquiline for the majorityof LMICs. 2) In August 2023, GDF announced that Johnson& Johnson, through a competitive tender process, offered
GDF and the countries it supplies a 55% price reduction forJohnson & Johnson’s 6-month bedaquiline treatment course,
supplying it at USD 130 per course.3) In September 2023,
Johnson & Johnson publicly reported that it will not enforce
any of its patents for bedaquiline in 134 LMICs.

13

AMR Benchmark Opportunities: progress update

Research-based pharmaceutical company

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?

Fully decouple incentives for sales agents from sales

Johnson & Johnson reports not deploying sales agents

volumes.

for bedaquiline, except in one country. However, globally,

Johnson & Johnson does not promote bedaquiline (Sirturo)for other antibiotics and antifungals, sales agents may bein most countries. Johnson & Johnson can apply the

deployed. Sales agents’ annual performance evaluation

practice of not promoting this product globally. Further, it

encompasses both financial and non-financial goals, andcan fully decouple incentives for sales agents from sales

their incentives are not solely based on sales volume

volumes of all antibacterial and antifungal medicines.

targets.

Publicly share raw data from surveillance programme.

Johnson & Johnson has shared the anonymised raw data

Johnson & Johnson runs the multinational Drug Resistancefrom the bedaquiline DREAM programme with the AMR

Emergence Assessment in MDR-TB (DREAM) programme,

Register, an initiative by Vivli.

which is focused on resistance against bedaquiline (Sirturo).

As with all datasets available on AMR Register, the data-

It can publicly share raw data from this surveillance pro-set is available for researchers to access after submitting agramme, anonymised and in a freely accessible format.

request, which is then subjected to a review by Vivli and therelevant company before data are shared.
Johnson & Johnson had also published aggregatedresults of the programme in a peer-reviewed, open-accessjournal.

14

Antimicrobial Resistance Benchmark 2021

JNJ

Overall Performance
2020

2021

68% 68%=

Access to Medicine Foundation

Johnson & Johnson
Large R&D-based pharmaceutical company
Stock exchange: NYSE • Ticker: JNJ • HQ: New Brunswick, NJ, USA • Employees: 136,400

JNJ
PERFORMANCE
Johnson & Johnson performs above average overall in its evaluated

Performance in the Benchmark

0%

Research Areas compared to the other large research-based
pharmaceutical companies in scope.
R&D: Johnson & Johnson is a middle-performing company in the
R&D Research Area. Its 14-project pipeline has two vaccines. It has
projects that target critical and/or urgent pathogens. Its two late-stage
development projects are covered by project-specific access plans.
Responsible Manufacturing: Performs strongly. Reports comprehensive

Appropriate Access: Performs well. Files some of its on- and off-patent

50%

80%

12/ 1572%

Access18/ 2580%

Stewardship
0%50%

16/ 20100%

How Johnson & Johnson was evaluated1

2.1 2.2 2.3 2.4

3

●

●

●

A R&D

Stewardship: Performs well. It generally does not promote bedaquiline(Sirturo®) to healthcare professionals. It shares raw data of its DREAM

1

2

3

B Manufacturing ●●●brochures and packaging for patients.

Points15/ 30

Manufacturing

to expand access and ensure continuous supply of its relevant products.

conflict of interest mitigation for its educational programmes. It adapts

100%

50%

R&D

medicines for registration in access countries. Reports some strategies

surveillance programme in a restricted manner. It reports comprehensive

/ 90
61/

Performance by Research Area

environmental risk-management strategy for own sites and suppliers;
quantifies discharge levels at all own sites.

Points68%

Overall score

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3

C Access

●

●

●

4

5

6

7

C Stewardship

●

●

●

●

●

●

●

●

● ● ● Scored●

OPPORTUNITIES FOR JOHNSON & JOHNSON

Not scored

CHANGES SINCE 2020
• Johnson & Johnson launched its inaugural

Diversify access plans for late-stage R&D projects. Johnson & Johnson has one medicine and one

satellite center for Global Health Discovery

vaccine in late-stage development. It can improve access to these new products, by developing

hosted at LSHTM focused on addressing theplans for registration, affordability and sustainable supply. For example, for their phase III vaccine,

threat of AMR and TB.

ExPEC9V, Johnson & Johnson can define the access countries where they will file for registration,• In February 2020, Johnson & Johnson joined

based on burden of disease, and where it considers ability-to-pay in its pricing strategy. Johnson &the Project to Accelerate New Treatments forJohnson can also engage with external partners with the expertise to help boost availability of theTuberculosis (PAN-TB), a collaboration among

vaccine in relevant territories once approved.

philanthropic, non-profit and private sec-

Ensure compliance with antibacterial discharge limits at own sites and suppliers by tracking andtors partners that aims to develop an investi-

publicly disclosing progress and results. Johnson & Johnson reports to set limits and to quantify

gational drug regimen capable of treating all

the discharge levels at its own sites and suppliers’ sites. To provide clear evidence of its progress, it
can track compliance at all sites and publicly disclose the results. Disclosure of information, includ-

forms of TB.
• Johnson & Johnson is funder and member ofing the results of audits and antibacterial discharge levels of its own sites and suppliers’ sites, isthe consortium VALUE-Dx. VALUE-Dx is theimportant. It can also publicly disclose the names and locations of its suppliers and waste-treatment

first Innovative Medicines Initiative project ini-plants for increased transparency.

tiated by six in vitro diagnostic companies who

Expand reach of bedaquiline (Sirturo®) for eligible MDR-TB patients. Johnson & Johnson has

work with 20 non-industry partners to combat

continued to reach more patients with MDR-TB through tenders, patient assistance programmes,

AMR and improve patient outcomes.

access price settings and public or private partnerships. It can further apply these mechanisms• Johnson & Johnson received two FDA indi-

to expand access and ensure diagnosed patients are treated, especially in countries where gaps

cation extension approvals for bedaqui-remain between diagnosis of MDR-TB and treatment.

line (Sirturo®)* for MDR-TB in adolescents

Fully decouple incentives for sales agents from sales volumes. Johnson & Johnson does not pro-

(12 - <18years) and pediatrics indications (5mote bedaquiline (Sirturo®) in most countries. Johnson & Johnson can apply the practice of notpromoting this product globally. Further, it can fully decouple incentives for sales agents from sales- <12years).
• In 2020, Johnson & Johnson collaborated

volumes of all antibacterial and antifungal medicines.

with the GDF Stop TB to reduce the price of

Publicly share raw data from surveillance programme. Johnson & Johnson runs the multinational

bedaquiline in eligible low- and middle-income

Drug Resistance Emergence Assessment in MDR-TB (DREAM) programme, which is focused on

countries.

resistance against bedaquiline (Sirturo®). It can publicly share raw data from this surveillance programme, anonymised and in a freely accessible format.

* As part of combination therapy of pulmonary tuberculosis due to multi-drugresistant M. tuberculosis.

110Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONSJNJSales by business segment

Therapeutic areas: Cardiovascular/metabolism/(other), Immunology,

2019

Infectious diseases, Neuroscience, Oncology, Pulmonary hypertension.

2020

Business segments: Consumer health, Medical devices, Pharmaceutical

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

42,19814,0530

Product categories: Consumer health products, Medical devices, Innovative
medicines, Vaccines

13,89825,96345,57220,000Consumer Health40,00060,000

Pharmaceutical

22,95980,000

Medical Devices

100,000
mn USDJNJ
Sales by region
2019

42,097

2020

43,1330

20,000

United States

39,96239,45140,00060,00080,000International

100,000
mn USDPIPELINE for pathogens in scope

PORTFOLIO for pathogens in scope

Pipeline size: 14 projects targeting pathogens in scope** (12 antibacterial

Comparatively small portfolio: At least 8 products: 3 antibacterial medi-

medicines; 2 antibacterial vaccines).

cines; 5 antifungal medicines

Development stages: 1 clinical project, ExPEC9V (formerly ExPEC10V)

On-patent medicines: 1 bedaquiline (Sirturo®)a Phase III, 9-valent vaccine for the prevention of invasive extraintestinal

Off-patent/generic medicines: 3 of 7 were selected for analysis** (itra-

pathogenic E. coli disease in adults; and 12 discovery/preclinical projects.

conazole [F], levofloxacin [W], miconazole [F])Novelty: 0 novel clinical-stage medicine projects.

AWaRe medicines***: 1 Watch group‘Critical’ and/or ‘urgent’ pathogens: Projects targeting invasive extraintes-

Anti-TB medicines***: 1

tinal pathogenic E. coli (ExPEC) and P. aeruginosa.
Regulatory approvals: 2 approvals. In August 2019, marketing authorisa-

JNJ
Pipeline for priority pathogens

tion by the FDA was granted for the adolescent indication (12 - <18 years)of the MDR-TB drug bedaquiline (Sirturo®)* and in May 2020, for the paediatric indication (ages 5 - < 12 years).

2

12

0

10

20

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

JNJ
Products on the market
3
0

5
10

20

● 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

A.2.1 Medium-sized pipeline

A.2.2 No clinical-stage novel medicines

Johnson & Johnson does not disclose pub-The company has 14 projects targeting patho-

Johnson & Johnson’s clinical-stage medicine

licly, or to the Benchmark, its R&D investments

gens in scope: 12 medicines and two vaccines,

pipeline consists of one candidate, the paediat-

during 2019 and 2020 in antibacterial and anti-

all targeting bacterial pathogens. Out of the 14

ric adaptation of bedaquiline (Sirturo®). Johnson

fungal medicines and/or vaccines for pathogens

projects, eight are in discovery stage, four are in& Johnson does not currently have any medi-in scope. Johnson & Johnson has pledged USD

preclinical stage, one is in clinical development

cine candidate that is considered novel in clinical

100 mn to the AMR Action Fund over the next

and one received marketing approval during thedevelopment.

ten years.

period of analysis.

Pipeline targeting priority pathogens: 14† As at 24 September 2021
Discovery

Pre-clinical♦ S. aureus vaccine

Phase I

Phase II

Phase III

Approval♦ Extraintestinal pathogenic E. coli vaccine(ExPEC9V) ‡Bedaquiline (Sirturo®)[M. tuberculosis][FDA/Aug-19]: additional
population: adolescent(12 - <18 years)[FDA/May-20]: additional population: paediatric (5 - <12 years)♦ Vaccine† Includes 11 conﬁdential projects not shown in the ﬁgure.
‡ Progressed to Phase III after the end of the period ofanalysis.

**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.

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Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

A.2.3 Two vaccine candidates

and Prevention (CDC). In clinical development,

will extend to the new pediatric approval: for use

Johnson & Johnson reports two vaccine pro-Johnson & Johnson has a vaccine candidate,in patients aged 5 - < 12 years and weighing at

jects in its pipeline. Its clinical-stage candidate,

ExPEC9V, that targets extraintestinal pathogenic

least 15 kg.

ExPEC9V is a Phase III vaccine targeting extrain-

E. coli. Johnson & Johnson also has projects that

testinal pathogenic E. coli. Johnson & Johnson

target P. aeruginosa.

Johnson & Johnson is planning to expand its

also has a vaccine candidate against S. aureus in
preclinical stage.

There are no clinical trials running in accesscountries§ for the EXPEC9V vaccine, but

A.3

Access and stewardship plans for late-Phase III trial to access countries.

stage projects
A.2.4 Candidates targeting critical and/or
urgent priorities

Johnson & Johnson has one vaccine (ExPEC9V)

Johnson & Johnson has projects targeting path-and one medicine in late-stage development[bedaquiline (Sirturo®)]. They are both covered

ogens defined as ‘critical’ by WHO’s list of prior-by project-specific access plans.

ity pathogens and/or characterised as ‘urgent’

The current stewardship activities ongoingthreats by the US Centers for Disease Control

for the adult indication of bedaquiline (Sirturo®)B

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

B.1

Comprehensive environmental risk-man-report how many suppliers have quantified dis-ronmental audits, conducted at its own sites, theagement for own sites and suppliers;

charge levels and are compliant with limits.

sites of suppliers and/or external private andsets limits at own sites and suppliers

Johnson & Johnson expects exter-

public waste-treatment plants; (2) a list of theseJohnson & Johnson reports a comprehen-

nal private waste-treatment plants to comply

suppliers and plants; or (3) the levels of antibac-

sive strategy to minimise the environmental

with its general environmental standards.

terial discharge from its own or suppliers’ sites.

impact of wastewaters and solid waste gen-Johnson & Johnson reports that it audits pri-erated from antibacterial manufacturing at its

vate waste-treatment plants based on risk andsites, including conducting audits every three

region. It also employs conservative measures

years. It reports setting discharge limits in thefor effluents sent to external public wastewater

receiving waters for all antibacterials manufac-

treatment plants.

tured at its sites, based on PNECs to limit AMR,

B.3

System in place to maintain production
quality for own and suppliers’ sites; norequests for official corrective action

Johnson & Johnson reports that its own
sites and suppliers have a system to main-

Publicly discloses some information on

tain high-quality antibacterial production, con-Johnson & Johnson also reports quantifying dis-environmental risk management

sistent with international GMP standards. Thischarge levels at all its own sites using a mass bal-Johnson & Johnson publishes some compo-

includes periodic risk-based audits and tracking

ance approach, verified by chemical analysis if

nents of its environmental risk-managementof corrective and preventive actions. In general,applicable.

strategy. It is a member of the AMR Industry

Johnson & Johnson also requires its pharmaceu-

Johnson & Johnson requires third-party

Alliance, which publishes a list of recommended

tical suppliers to audit their own supplier sites

suppliers of antibacterial APIs and drug products

antibacterial discharge targets. It discloses thatbased on risk. The Benchmark found no requests

to follow the same standards, including limits

it has completed audits and an environmental

for official corrective action from the FDA orbased on PNECs. It reports conducting on-siterisk assessment of all its pharmaceutical sup-EMA related to non-conformities with cGMP at

audits of its suppliers typically every three years.

pliers located in China and India, which also

Johnson & Johnson’s own sites or any subsidiar-Johnson & Johnson requests and reviews thecovers antibacterial discharge levels. Johnson &ies that manufacture antibacterials.

discharge levels of its suppliers. It does not

Johnson does not publish: (1) the results of envi-

as recommended by the AMR Industry Alliance.

C

B.2

APPROPRIATE ACCESS & STEWARDSHIP – ACCESS

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries§
Johnson & Johnson is not eligible for indica-

filed for registration in at least one LIC.

tors: C.1.3 and C.2.3. For more information, see
Appendix VII.

lative 700,000 patients worldwide by 2025.
Bedaquiline is available in all 30 WHO high-bur-

C.2.1 Several strategies to expand access toden countries for MDR-TB.

its on-patent medicine
C.1.1

Filed to register on-patent medicines in

Johnson & Johnson performs above average.

30 access countries

It aims to expand access to its one relevant

C.2.2 Limited information on strategies toexpand access to off-patent/generic
medicines

Johnson & Johnson performs above average,

on-patent medicine in access countries throughfiling its one relevant on-patent medicine fortenders, patient assistance programmes, accessJohnson & Johnson has an average perfor-

registration in 30 access countries, including

price settings and public or private partner-

mance. It has set equitable tiered-pricing princi-

eight LICs. The medicine is the MDR-TB medi-

ships. It collaborates with the GDF-Stop TB

ples and publicly states to apply equitable pric-cine bedaquiline (Sirturo®). Johnson & Johnson

Partnership to provide 100 mg bedaquiline at

ing policies to its antifungal itraconazole andpublicly discloses on its company’s website

a global access price of USD 340 per 6-month

antibiotic levofloxacin. Johnson & Johnson pro-where bedaquiline was filed for registration.

treatment course to GDF-eligible countries.

vides evidence of patient reach and geographic

The GDF-Stop TB Partnership also provides

reach for two of its three relevant products in

C.1.2 Filed to register off-patent/generic med-

the paediatric formulation of bedaquiline (20scope. Details were provided under the basis of

icines in 29 access countries on averagemg) at a price of USD 200 per 6-month treat-confidentiality.

Johnson & Johnson performs above average,

ment course. Johnson & Johnson provides evi-filing all its three sample off-patent/generic

dence of patient reach and geographic reach for

medicines for registration in 29 access countries

all its reported approaches. It publicly commits

on average. All its three sample products are

to providing its MDR-TB medicine to a cumu-§ 102 low- and middle-income countries

where better access to medicine is mostneeded.

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Antimicrobial Resistance Benchmark 2021

C.3

Access to Medicine Foundation

Several strategies to ensure continuous

casts and global donor grant budgeting cycles.

Pharmstandard (Russia). It mitigates substand-supplyIt mitigates against shortage risks by keeping a

ard and falsified products by having a dedicatedJohnson & Johnson performs above aver-buffer stock for APIs and finished products. Bothteam. It uses packaging security features andage, with strategies reported in all four areas

bedaquiline API and finished product are manu-

digital technologies to detect illicit trade.

assessed. It ensures accurate demand plan-

factured in India with flexibility to scale produc-ning and data sharing by forecasting demandtion. It reports several capacity building or tech-of bedaquiline (Sirturo®) based on local tender

nology transfer initiatives including a technol-

patterns and utilisation trends in high burden

ogy transfer for the formulation, filling, and pack-

MDR-TB countries, distributor demand fore-

aging processes of bedaquiline including withC

APPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

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

Comprehensive COI mitigation strategies

C.6

in place for its educational programmes

Makes two types of brochure and/or packaging adaptations to facilitate
appropriate use by patientsJohnson & Johnson performs strongly in conflict of interest (COI) mitigation for the five

Johnson & Johnson adapts brochures and pack-

AMR-related educational programmes foraging to facilitate the appropriate use of bedaq-

HCPs assessed by the Benchmark. To mitigate

uiline (Sirturo®) by patients. Johnson & Johnson

COI for all five programmes, it provides finan-

performs well, taking account of language andcial resources to independent third parties (Theadherence to treatment. It produces a pack-

Union, the Chinese and Indonesian govern-

age insert with information in four languages toments) to carry out the programme.

streamline distribution. Further, it packaged a
6-month treatment regimen in a single bottle to

C.5

Engages in sales practices but does notfacilitate patient adherence to treatment.

engage in marketing practices to addressappropriate use
Johnson & Johnson performs above averagein sales practices. It does not deploy any sales

C.7

Active in one AMR surveillance programme; shares raw data in a restricted
manneragents to promote bedaquiline (Sirturo®) toJohnson & Johnson runs the multinational

healthcare professionals except in one country.

Drug Resistance Emergence Assessment in

However, for the remaining antibacterial and/or

MDR-TB (DREAM) programme, which is focused

antifungal medicines it does not report whether

on resistance against bedaquiline (Sirturo®) init decouples incentives for sales agents from11 countries and has been running since 2015.

sales volumes to help prevent the inappropriate

Johnson & Johnson shares the raw data (fromuse of such medicines.

its clinical trials) through the Yale University

Johnson & Johnson does not engage inOpen Data Access (YODA) platform, which canmarketing practices that aim to address the

only be accessed via approval through an inde-appropriate use of its antibacterial and/or anti-

pendent scientific committee.

fungal medicines as its marketing materials do not reflect emerging resistance trends
or include treatment guidelines for healthcare
professionals.

113