Johnson & Johnson

Rank

4.03

Score

The full report card of Johnson & Johnson in PDF format.

Performance in the 2022 Index

2nd place. Johnson & Johnson is a leading company and demonstrates strong performance across all three Technical Areas. The company performs strongly across all assessment criteria including access strategies, R&D access planning and capacity building.

Governance of Access: 2nd place. Johnson & Johnson has a strong performance in this area. It has an access-to-medicine strategy integrated into its overall corporate strategy and a robust set of compliance controls to mitigate the risk of non-compliance in countries in scope of the Index. It also incentivises its senior executives, the CEO and in-country and regional managers to perform on access-to-medicine goals and discloses the outcomes of its access-to-medicine activities.

Research & Development: 2nd place. Johnson & Johnson is a leading company in this area. The company has a large-sized priority pipeline compared its peers with access plans in place for all late-stage pipeline candidates. It also performs strongly in R&D capacity building and has an access planning framework that covers all projects in the pipeline.

Product Delivery: 3rd place. Johnson & Johnson performs strongly in this area. The company engages in high-quality capacity building initiatives across all fields (i.e., manufacturing, supply chain and health systems strengthening). The company applies access strategies broadly, with several products having strategies across all country income classifications. It leads in its approach to access strategies for supranationally procured products.

Opportunities for Johnson & Johnson

Improve the quality of access plans for R&D projects for non-communicable diseases. Johnson & Johnson has access plans in place for all its late-stage R&D projects in the pipeline. The company can plan beyond registration by including more access components such as equitable pricing plans for each project, including cetrelimab, a monoclonal antibody in development for bladder cancer, and aprocitentan, an investigational treatment for hypertension.

Expand supply chain process reviews to more countries. Johnson & Johnson’s Global Public Health unit conducted supply chain process reviews in sub-Saharan African countries including Kenya, Uganda and Nigeria. These reviews revealed a gap in leadership skills in the supply chain. In response, the company launched the Public Health Supply Chain CEO Forum. The company can conduct needs assessments in further countries in sub-Saharan Africa and expand the forum to additional countries where supply chain leadership gaps are seen.

File patented medicines for HIV for registration in more countries. Johnson & Johnson’s antiretrovirals darunavir/cobicistat (Prezcobix®/Rezolsta®) and darunavir/ cobicistat/emtricitabine/tenofovir alafenamide (Symtuza®) have been filed in 12 and 5 countries in scope of the Index respectively. Both products can be filed for registration in countries with a high burden of disease, such as Mozambique, South Africa and Zimbabwe.

Expand access to patented products in countries with the highest burden of disease. Johnson & Johnson has access strategies in some LMICs for canagliflozin (Invokana®), indicated for type 2 diabetes mellitus, and for ibrutinib (Imbruvica®), indicated for leukaemia. The company can apply access strategies such as equitable pricing and/or non-exclusive voluntary licensing to expand patient reach, particularly in countries in scope of the Index where the burden of disease is the highest, such as Sri Lanka (for diabetes) and Afghanistan (for leukaemia).

Changes since the 2021 Index

Expanded the scope of its Global Public Health organisation to include a focus on Global Surgery, including obstetric fistula.
Launched new Health for Humanity 2025 Goals, including a goal on Global Access Plans.
Shipped approximately 270 million doses of the Johnson & Johnson COVID-19 vaccine to Africa at a not-for-profit price.
Entered into IP licensing agreements and conducted voluntary technology transfers for its COVID-19 vaccine across 10 manufacturing facilities, including in India and South Africa.
Announced an agreement to provide its COVID-19 vaccine technology to South Africa-based Aspen SA Operations (Pty) Ltd to manufacture its own branded vaccine.
Received WHO Prequalification for its Ebola vaccine (Ad26.ZEBOV-GP) (Zabdeno®) and Ebola vaccine (MVA-BN-Filo) (Mvabea®).
Announced several initiatives to help find the ‘Missing Millions’ of undiagnosed people living with TB, including with the Global Fund.
Launched a network of Global Health Discovery Centers to accelerate innovation and tackle pandemic threats.
Completed Phase 1 clinical study evaluating dengue-specific antiviral for treatment and prophylactic use.
Invested USD 100 million into the newly launched Antimicrobial Resistance (AMR) Action Fund.
Commenced the first interventional clinical trial for schizophrenia in Africa.
Marked over 2 billion doses of mebendazole (Vermox®) donated since 2006.

Sales and operations

Business segments: Consumer health, medical technologies and pharmaceutical.

Therapeutic areas: Cardiovascular, immunology, infectious diseases, metabolism, neuroscience, oncology, pulmonary hypertension and other diseases.

Product categories: Consumer health products, innovative medicines, medical technologies and vaccines.

M&A news: Johnson & Johnson acquired Momenta Pharmaceuticals, Inc. in October 2020 for USD 6.5 billion.

Johnson & Johnson's products are sold in 95 out of 108 countries in scope of the Index. Johnson & Johnson has sales offices in 24 countries and sells via suppliers and/or pooled procurement in an additional 71 countries.

Sales by segment (2021) – in USD

Consumer health 14.64 bn

Pharmaceutical 52.08 bn

Medical technologies 27.06 bn

Total 93.78 bn

Sample of pipeline and portfolio assessed by the Index

PIPELINE for diseases in scope

Johnson & Johnson has a total of 101 R&D projects in scope with 64 of these projects targeting priority diseases. The other 37 R&D projects target other diseases in scope. Of the projects targeting priority diseases, the focus is on viral hepatitis (B and C) (12 projects), HIV/AIDS (11 projects), and tuberculosis (11 projects). Of the projects targeting other diseases in scope, the focus is on oncology (25). Forty R&D projects are in late-stage development. These target either a priority disease (19) or address a public health need in LMICs (21).* Evidence of access planning was in place for 100% of these projects.

PORTFOLIO as selected for analysis by the Index

Johnson & Johnson has 26 medicines in scope, 19 of which are on patent, and two vaccines. 42% of the medicines (11) are on the WHO EML. The off-patent medicines target the neglected tropical diseases soil-transmitted helminthiasis and echinococcosis and the non-communicable diseases (NCDs) (6) relating to cancer (3), mental health conditions (2) and kidney diseases. The on-patent medicines target communicable diseases such as HIV/AIDS (8) and tuberculosis, and NCDs such as cancer (5), mental health conditions (2), diabetes (2) and Alzheimer's disease. The company also has two vaccines targeting Ebola and COVID-19.

Performance breakdown

Governance of Access

Places 2nd, scores 4.43

Has an access-to-medicine strategy with measurable objectives, integrated within its overall corporate strategy. Johnson & Johnsons performs strongly. Its access strategy, embedded in its Global Public Health unit and Janssen Access and Pricing Principles, covers all therapeutic areas in which the company is involved. The highest responsibility for access lies directly with the board, namely with the Science & Technology Committee.

Provides evidence of financial and non-financial access-related incentives at the executive level. Johnson & Johnson performs strongly. It incentivises its senior executives, including its CEO and members of the Executive Committee, and regional managers to take action on access to medicine with financial and non-financial rewards. Senior management, including the CEO, have enterprise-level targets as well as access-related performance indicators, including KPIs to improve access to medicine, as part of their annual goals and objectives.

Publicly discloses outcomes of its access-to-medicine activities. Johnson & Johnson performs strongly in transparency of access activities. It publicly discloses commitments, measurable goals, objectives and targets for improving access to medicine in countries in scope of the Index. It facilitates accountability and transparency by consistently sharing the outcomes of its access-to-medicine activities in a centralised manner within its annual Health for Humanity Goals Progress Scorecard.

Performs above average in responsible promotional practices. Johnson & Johnson’s sales agents are not solely incentivised on sales volume targets. The company, however, sets sales incentives at the individual level for agents. It does not publicly disclose information related to transfers of values to healthcare professionals in countries in scope of the Index (e.g. payments for attending events or promotional activities) except as required by law or national/regional trade associations (e.g., EFPIA), though it has policies and procedures in place limiting transfers of values to healthcare professionals in countries in scope of the Index. In addition, the company reports not using sales and marketing representatives for some products related to diseases in scope, such as HIV/AIDS medicines.

Has a robust set of compliance controls to ensure that governance efforts are not undermined by non-compliant or corrupt activities. Johnson & Johnson performs strongly, demonstrating evidence of all components looked for by the Index: fraud-specific risk assessment, country risk-based assessment, a continuous system to monitor activities, audits (both internal and external, covering third parties and in all countries where it operates) and has formal processes to ensure third-party compliance with company standards. No breaches in countries in scope of the Index were publicly found in the period of analysis.

Publicly supports international agreements, such as the Doha Declaration on the TRIPS agreement. Johnson & Johnson publicly recognises and supports international agreements including the TRIPS Agreement, and states that it advocates for strong intellectual property (IP) systems that promote innovation. The company expresses reservations on compulsory licensing, namely that it should be limited to certain circumstances when alternatives are exhausted. There is evidence of industry association lobbying on IP and the usage of TRIPS flexibilities, namely of compulsory licensing, by national governments in some countries in scope of the Index. As a member of the industry association, Johnson & Johnson, like all other member companies in scope of the Index, is by default connected to this activity.

Research and Development

Places 2nd, scores 3.73

Access planning processes encompass all projects in the pipeline. Johnson & Johnson has a structured process in place to develop access plans during R&D. The process is intended to be applied to all R&D projects (both in-house and collaborative) for diseases in scope of the Index. In general, Johnson & Johnson begins developing access plans for R&D projects in Phase II of clinical development.

A large-sized priority R&D pipeline compared to peers, with access plans in place for 100% (19/19) of the late-stage candidates. Johnson & Johnson has a priority R&D pipeline of 64 projects, including 19 late-stage projects that target a priority gap. The company focuses on various priority areas, including viral hepatitis (B and C), HIV/ AIDS and tuberculosis. Of Johnson & Johnson's 19 late-stage candidates targeting a priority product gap, all have evidence of an access plan in place. It provides evidence of access plans with a range of components including equitable pricing strategies and plans for registration in countries in scope of the Index. Notably, the access plan for the two-shot regimen Ebola vaccine (Ad26.ZEBOV-GP) (Zabdeno®) and Ebola vaccine (MVA-BN-Filo) (Mvabea®) is multifaceted, comprising of WHO prequalification, health systems strengthening and capacity building initiatives through the Johnson & Johnson vaccination monitoring platform Vxnaid™, and product donations.

Many projects address a public health need in LMICs,* with 100% (21/21) of late-stage projects covered by access plans. In this analysis, Johnson & Johnson has 21 late-stage R&D projects that target a disease and/or product gap not yet established as a priority by global health stakeholders. These projects are all deemed by the Index to offer a clear public health benefit for people living in LMICs.* Primarily, these projects have clinical trials in countries in scope of the Index and/or are first-in-class molecules. The projects mainly target cancer. Johnson & Johnson provides evidence of access plans for all 21 eligible projects.

Does not publicly disclose R&D investment data disaggregated by disease category, product type or phase of development. However, Johnson & Johnson does disclose fully disaggregated R&D investment data to Policy Cures Research.

All five R&D capacity building initiatives included for analysis meet all Good Practice Standards. Johnson & Johnson leads in this area. The number of initiatives meeting all inclusion criteria is higher than average and more initiatives meet all Good Practice Standards than what is average for this indicator. For example, the Johnson & Johnson Global Public Health R&D Fellowship Program provides training in drug development to mid-career African doctors and scientists.

Product Delivery

Places 3rd, scores 4.09

Public commitment not to enforce patents in countries in scope. Johnson & Johnson has had a specific policy since 2012 not to enforce the patents it owns and controls on the antiretroviral drug darunavir (Prezista®) in sub-Saharan Africa and Least Developed Countries. In 2015, it expanded the geographical scope of the policy for paediatric products used in LMICs.

Publicly discloses information on patent status. Like most of its peers, Johnson & Johnson discloses the patent statuses for small molecules in scope via the Pat-INFORMED database. Johnson & Johnson discloses patent information including filing date, grant number, grant date and jurisdiction.

Performs above average in terms of sharing intellectual property (IP) assets with third-party researchers. Johnson & Johnson engaged in two new IP-sharing agreements with third-party research institutions or drug discovery initiatives established during the current analysis period that meet all inclusion criteria for evaluation. The company does have existing agreements of this nature in place that were established before the current Index cycle and meet all inclusion criteria for evaluation.

Uses licensing to enable generic supply. Johnson & Johnson has a non-exclusive voluntary licensing agreement for one compound (for diseases in scope). Its licence for rilpivirine (Edurant®) encompasses 83 countries in scope, including 57 middle income countries. It has also issued a non-assert declaration for one patented compound in scope, darunavir (Prezista®).

Filed to register new products in 15 countries in scope on average. Johnson & Johnson has filed filed six products in at least one country in scope of the Index with the highest burden of disease (for products that could be assessed with available global burden of disease data, which excludes COVID-19). Among new products, its most widely filed is the Johnson & Johnson COVID-19 vaccine, rapidly authorized in 41 countries within the scope of the Index, 13 of which are LICs. Examples include Somalia, Sudan and Uganda. Johnson & Johnson also received emergency use waivers or import permits in 31 countries in scope of the Index. Among old products, canagliflozin/ metformin (Vokanamet®/Invokamet®) has been filed in 18 countries within the scope of the Index, including one high burden disease country.

Has access strategies for all supranationally procured products in scope for this analysis. Johnson & Johnson leads in securing access for products procured supranationally. For the four products assessed in this category, the company demonstrates strategies both in countries eligible for supply from such procurers, and also in at least one country not eligible for such supply. For example, the company supplied its Johnson & Johnson COVID-19 vaccine at a not-for-profit price via a supranational procurement agreement with the African Vaccine Acquisition Trust (AVAT) as well as two advance purchase agreements with the South African government.

Has access strategies for the majority of healthcare practitioner-administered products in scope of this analysis. Johnson & Johnson performs above average in this area. For three of the five products assessed, the company provides examples of access strategies which consider affordability in countries of all assessed income levels (UMIC, LMIC, LIC). The company makes efforts to reach additional patients using strategies considering relevant payers' ability to pay. For example, Johnson & Johnson secured bendamustine hydrochloride (Ribomustin®) reimbursement in both public institutions and private health insurance in Brazil. The company provides evidence of how patient reach has been increased through the approaches used in some of the country examples provided.

Has access strategies for the majority of its self-administered products for countries in scope for this analysis. Johnson & Johnson performs above average in this area. For two of the five products assessed, the company provides examples of access strategies which consider affordability in countries of all assessed income levels (UMIC, LMIC, LIC). It makes efforts to reach additional patients through pricing strategies considering relevant payers' ability to pay and patient assistance programmes. For example, in an LIC for one cancer product, it provided evidence of pricing and non-pricing strategies to ensure continuous patient care while implementing health systems strengthening initiatives. Johnson & Johnson provides evidence of patient reach.

Four of the five manufacturing capacity building initiatives included meet all Good Practice Standards. Johnson & Johnson's performance is above average in this area. The number of initiatives meeting all inclusion criteria is higher than average and more initiatives meet all Good Practice Standards (GPS) than what is average for this indicator. For example, the company collaborated with Aspen Pharmacare Limited, a manufacturer in South Africa to transfer technology to produce the Johnson & Johnson COVID-19 vaccine. This initiative meets all GPS.

All five supply chain capacity building initiatives included for analysis meet all Good Practice Standards. Johnson & Johnson is one of the leaders in this area. The number of initiatives meeting all inclusion criteria is higher than average and more initiatives meet all GPS than what is average for this indicator. For example, the company is involved in the Strategic Training Executives Programme (STEP 2.0) which is a targeted leadership and change management solution that trains public health supply chain managers and leaders in LMICs.

All five health systems strengthening initiatives included for analysis meet all Good Practice Standards. Johnson & Johnson is one of the leaders in this area. The number of initiatives meeting all inclusion criteria is higher than average and more initiatives meet all Good Practice Standards than what is average for this indicator. For example, Johnson & Johnson Global Public Health developed Vxnaid™, a vaccination monitoring platform which supports adherent vaccine administration in the framework of clinical studies or campaigns, including support of the Rwandan Ministry of Health’s large-scale Ebola vaccination campaign. The company’s ultimate goal is for the platform to be available on a more global scale.

Has engaged in scaling up two and piloting four inclusive business models. Johnson & Johnson performs above average in the use of inclusive business models aimed at meeting the access needs of populations at the base of the income pyramid (including other underserved populations) in LMICs. Johnson & Johnson Impact Ventures, a fund within the Johnson & Johnson Foundation, helped to scale up South Lake Medical Center, a specialised low-cost primary care hospital in Naivasha, Kenya that runs a hub-and-spoke healthcare model.

Performs above average in terms of ensuring continuous supply of medicines in LMICs. Johnson & Johnson is involved in technology transfers with third-party manufacturers in LMICs, and has a system in place to work with relevant stakeholders to communicate issues that may affect the supply chain, works with several active pharmaceutical ingredient suppliers, manages a buffer stock of relevant products and is involved in supply chain capacity building initiatives.

Has a procedure for reporting substandard and falsified (SF) medicines in countries in scope of the Index in less than ten days. Johnson & Johnson has a procedure for reporting SF medicines to national health authorities within five days. The company reports aiming at reporting within two days if the case presents a direct and serious or life-threatening risk to patient or healthcare professional. It distinguishes quicker reporting time frames for cases which only require visual inspection to be confirmed.

Donates in response to expressed need and monitors delivery. Johnson & Johnson has public policies and supply processes in place to ensure ad hoc donations are carried out rapidly in response to expressed need, and it monitors the delivery of donations.

Publicly commits to the achievement of elimination, eradication or control goals in one structured donation programme for neglected tropical diseases or malaria. Johnson & Johnson publicly commits to supporting the control of soil-transmitted helminthiasis as a public health problem through its donation of mebendazole (Vermox®) until the end of 2025 in 51 countries in scope of the Index.

All companies were assessed based on information that was valid in the latest period of analysis (ending at 31 May 2022). This data was either submitted by companies, found in the public domain or was accessible through other sources.

The term LMICs is used to denote all low- and middle-income countries in scope of the Index, except when analysing companies’ access strategies where the use of LMIC refers to lower-middle income countries as per the World Bank income groups classification. Likewise, the terms LIC and UMIC refer to low income countries and upper-middle income countries.

*50 diseases and 243 product gaps in scope have been established as a priority by global health stakeholders. For other diseases, the Index used a set of criteria to determine which projects in the pipeline offer a clear public health benefit to patients in LMICs. Only projects in the clinical phase of development were included for this analysis.

**Neglected tropical diseases, while also communicable, are highlighted separately throughout the Index.

***Other includes projects that have a technical lifecycle and projects that follow a different development cycle (e.g. diagnostics).

†Products included in the analysis were selected using a set of criteria determined by stakeholder consensus.

‡Other includes vector control product.

Download the report card of Johnson & Johnson.

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compare

Overall score

68%

61/90

compare

R&D

50%

Points 15/30

Manufacturing

80%

12/15

Access

72%

18/25

Stewardship

80%

16/20

0% 50% 100%

Opportunities: next steps for addressing AMR

2021 OPPORTUNITY: Diversify access plans for late-stage R&D projects. Johnson & Johnson has one medicine and one vaccine in late-stage development. It can improve access to these new products, by developing plans for registration, affordability and sustainable supply. For example, for their phase III vaccine, ExPEC9V, Johnson & Johnson can define the access countries where they will file for registration, based on burden of disease, and where it considers ability-to-pay in its pricing strategy. Johnson & Johnson can also engage with external partners with the expertise to help boost availability of the vaccine in relevant territories once approved.

2023 UPDATE: Clinical trials for the ExPEC9V vaccine candidate are actively recruiting participants, including in two low- and middle-income countries (LMICs): China and Thailand.
In October 2023, Johnson & Johnson announced a development and commercialisation agreement with Sanofi for the candidate. It is too early for the companies to disclose access plans for the ExPEC9V vaccine candidate.

2021 OPPORTUNITY: Ensure compliance with antibacterial discharge limits at own sites and suppliers by tracking and publicly disclosing progress and results. Johnson & Johnson reports to set limits and to quantify 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, including the results of audits and antibacterial discharge levels of its own sites and suppliers’ sites, is important. It can also publicly disclose the names and locations of its suppliers and waste-treatment plants for increased transparency.

2023 UPDATE: Johnson & Johnson continues to report implementing the AMR Industry Alliance’s Antibiotic Manufacturing Standard. However, based on public information, it is unclear how many of its own and supplier sites are compliant with discharge limits.
Similar to 2021, Johnson & Johnson does not publicly disclose individual audit results containing antibacterial discharge levels for both its own sites and suppliers’ sites. Furthermore, the company does not disclose the names and locations of its suppliers.

2021 OPPORTUNITY: Expand reach of bedaquiline (Sirturo) for eligible MDR-TB patients. Johnson & Johnson has continued to reach more patients with MDR-TB through tenders, patient assistance programmes, access price settings and public or private partnerships. It can further apply these mechanisms to expand access and ensure diagnosed patients are treated, especially in countries where gaps remain between diagnosis of MDR-TB and treatment.

2023 UPDATE: Johnson & Johnson continues to expand access to bedaquiline (Sirturo®) for multidrug-resistant tuberculosis (MDR-TB) patients. By the end of 2020, Johnson & Johnson had provided more than 317,000 courses of bedaquiline cumulatively to patients in 144 countries, including all 30 high-burden MDR-TB countries. By September 2023, this number has more than doubled to a total of 745,000 courses of bedaquiline, provided to patients in 159 countries, including 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 agreement with 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 majority of 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 for Johnson & 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.

2021 OPPORTUNITY: Fully decouple incentives for sales agents from sales volumes. Johnson & Johnson does not promote bedaquiline (Sirturo) in most countries. Johnson & Johnson can apply the practice of not promoting this product globally. Further, it can fully decouple incentives for sales agents from sales volumes of all antibacterial and antifungal medicines.

2023 UPDATE: Johnson & Johnson reports not deploying sales agents for bedaquiline, except in one country. However, globally, for other antibiotics and antifungals, sales agents may be deployed. Sales agents’ annual performance evaluation encompasses both financial and non-financial goals, and their incentives are not solely based on sales volume targets.

2021 OPPORTUNITY: Publicly share raw data from surveillance programme. Johnson & Johnson runs the multinational Drug Resistance Emergence Assessment in MDR-TB (DREAM) programme, which is focused on resistance against bedaquiline (Sirturo). It can publicly share raw data from this surveillance programme, anonymised and in a freely accessible format.

2023 UPDATE: Johnson & Johnson has shared the anonymised raw data from the bedaquiline DREAM programme with the AMR Register, an initiative by Vivli.
As with all datasets available on AMR Register, the dataset is available for researchers to access after submitting a request, which is then subjected to a review by Vivli and the relevant company before data are shared.
Johnson & Johnson had also published aggregated results of the programme in a peer-reviewed, open-access journal.

2021: Performance

Johnson & Johnson performs above average overall in its evaluated 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 environmental risk-management strategy for own sites and suppliers; quantifies discharge levels at all own sites.

Appropriate access

Performs well. Files some of its on- and off-patent medicines for registration in access countries. Reports some strategies to expand access and ensure continuous supply of its relevant products.

Stewardship

Performs well. It generally does not promote bedaquiline (Sirturo) to healthcare professionals. It shares raw data of its DREAM surveillance programme in a restricted manner. It reports comprehensive conflict of interest mitigation for its educational programmes. It adapts brochures and packaging for patients.

2021: Pipeline and Portfolio

Looking at bacterial and fungal pathogens

The AMR Benchmark evaluates pharmaceutical companies on the size and relevance of their R&D pipelines and on the actions they are taking to ensure their products on the market are accessible and being used responsibly.

Portfolio

Products on the market

Comparatively small portfolio: At least 8 products: 3 antibacterial medicines; 5 antifungal medicines
On-patent medicines: 1 bedaquiline (Sirturo)
Off-patent/generic medicines: 3 of 7 were selected for analysis** (itraconazole [F], levofloxacin [W], miconazole [F])
AWaRe medicines***: 1 Watch group
Anti-TB medicines***: 1

Pipeline

Pipeline for priority pathogens

Pipeline size: 14 projects targeting pathogens in scope** (12 antibacterial medicines; 2 antibacterial vaccines).
Development stages: 1 clinical project, ExPEC9V (formerly ExPEC10V) a Phase III, 9-valent vaccine for the prevention of invasive extraintestinal pathogenic E. coli disease in adults; and 12 discovery/preclinical projects.
Novelty: 0 novel clinical-stage medicine projects.
‘Critical’ and/or ‘urgent’ pathogens: Projects targeting invasive extraintestinal pathogenic E. coli (ExPEC) and P. aeruginosa.
Regulatory approvals: 2 approvals. In August 2019, marketing authorisation 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).

2021: Sales & Operations

Scope, scale and focus of the business

Therapeutic areas: Cardiovascular/metabolism/(other), Immunology, Infectious diseases, Neuroscience, Oncology, Pulmonary hypertension.
Business segments: Consumer health, Medical devices, Pharmaceutical
Product categories: Consumer health products, Medical devices, Innovative medicines, Vaccines
M&A since 2020: None in the antibacterial and/or antifungal sectors

Sales by business segment

Sales by region

2021: Performance breakdown

Explore Johnson & Johnson's performance in detail, including the drivers behind any movement and the main areas where it scores well or poorly compared to peers.

Research & Development

Investments in R&D
Medium-sized pipeline
No clinical-stage novel medicines
Two vaccine candidates
Candidates targeting critical and/or urgent priorities
Access and stewardship plans for late stage projects

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

A.1 Investments in R&D
Johnson & Johnson does not disclose publicly, or to the Benchmark, its R&D investments during 2019 and 2020 in antibacterial and antifungal medicines and/or vaccines for pathogens in scope. Johnson & Johnson has pledged USD 100 mn to the AMR Action Fund over the next ten years.

A.2.1 Medium-sized pipeline
The company has 14 projects targeting pathogens in scope: 12 medicines and two vaccines, all targeting bacterial pathogens. Out of the 14 projects, eight are in discovery stage, four are in preclinical stage, one is in clinical development and one received marketing approval during the period of analysis.

A.2.2 No clinical-stage novel medicines
Johnson & Johnson’s clinical-stage medicine pipeline consists of one candidate, the paediatric adaptation of bedaquiline (Sirturo®). Johnson & Johnson does not currently have any medicine candidate that is considered novel in clinical development.

A.2.3 Two vaccine candidates
Johnson & Johnson reports two vaccine projects in its pipeline. Its clinical-stage candidate, ExPEC9V is a Phase III vaccine targeting extraintestinal pathogenic E. coli. Johnson & Johnson also has a vaccine candidate against S. aureus in preclinical stage.

A.2.4 Candidates targeting critical and/or urgent priorities
Johnson & Johnson has projects targeting pathogens defined as ‘critical’ by WHO’s list of priority pathogens and/or characterised as ‘urgent’ threats by the US Centers for Disease Control and Prevention (CDC). In clinical development, Johnson & Johnson has a vaccine candidate, ExPEC9V, that targets extraintestinal pathogenic E. coli. Johnson & Johnson also has projects that target P. aeruginosa.

A.3 Access and stewardship plans for late-stage projects
Johnson & Johnson has one vaccine (ExPEC9V) and one medicine in late-stage development [bedaquiline (Sirturo®)]. They are both covered by project-specific access plans. The current stewardship activities ongoing for the adult indication of bedaquiline (Sirturo®) will extend to the new pediatric approval: for use in patients aged 5 - < 12 years and weighing at least 15 kg.
There are no clinical trials running in access countries§ for the EXPEC9V vaccine, but Johnson & Johnson is planning to expand its Phase III trial to access countries.

Responsible Manufacturing

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

Comprehensive environmental risk-management for own sites and suppliers; sets limits at own sites and suppliers
Publicly discloses some information on environmental risk management
System in place to maintain production quality for own and suppliers’ sites; no requests for official corrective action

Evaluated: antibacterials manufacturing (APIs and drug products)

B.1 Comprehensive environmental risk-management for own sites and suppliers; sets limits at own sites and suppliers
Johnson & Johnson reports a comprehensive strategy to minimise the environmental impact of wastewaters and solid waste generated from antibacterial manufacturing at its sites, including conducting audits every three years. It reports setting discharge limits in the receiving waters for all antibacterials manufactured at its sites, based on PNECs to limit AMR, as recommended by the AMR Industry Alliance. Johnson & Johnson also reports quantifying discharge levels at all its own sites using a mass balance approach, verified by chemical analysis if applicable.

Johnson & Johnson requires third-party suppliers of antibacterial APIs and drug products to follow the same standards, including limits based on PNECs. It reports conducting on-site audits of its suppliers typically every three years. Johnson & Johnson requests and reviews the discharge levels of its suppliers. It does not report how many suppliers have quantified discharge levels and are compliant with limits.

Johnson & Johnson expects external private waste-treatment plants to comply with its general environmental standards. Johnson & Johnson reports that it audits private waste-treatment plants based on risk and region. It also employs conservative measures for effluents sent to external public wastewater treatment plants.

B.2 Publicly discloses some information on environmental risk management
Johnson & Johnson publishes some components of its environmental risk-management strategy. It is a member of the AMR Industry Alliance, which publishes a list of recommended antibacterial discharge targets. It discloses that it has completed audits and an environmental risk assessment of all its pharmaceutical suppliers located in China and India, which also covers antibacterial discharge levels. Johnson & Johnson does not publish: (1) the results of environmental audits, conducted at its own sites, the sites of suppliers and/or external private and public waste-treatment plants; (2) a list of these suppliers and plants; or (3) the levels of antibacterial discharge from its own or suppliers’ sites.

B.3 System in place to maintain production quality for own and suppliers’ sites; no requests for official corrective action
Johnson & Johnson reports that its own sites and suppliers have a system to maintain high-quality antibacterial production, consistent with international GMP standards. This includes periodic risk-based audits and tracking of corrective and preventive actions. In general, Johnson & Johnson also requires its pharmaceutical suppliers to audit their own supplier sites based on risk. The Benchmark found no requests for official corrective action from the FDA or EMA related to non-conformities with cGMP at Johnson & Johnson’s own sites or any subsidiaries that manufacture antibacterials.

Appropriate Access

Performs well. Files some of its on- and off-patent medicines for registration in access countries. Reports some strategies to expand access and ensure continuous supply of its relevant products.

Filed to register on-patent medicines in 30 access countries
Filed to register off-patent/generic medicines in 29 access countries on average
Several strategies to expand access to its on-patent medicine
Limited information on strategies to expand access to off-patent/generic medicines
Several strategies to ensure continuous supply

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries§

Johnson & Johnson is not eligible for indicators: C.1.3 and C.2.3. For more information, see Appendix VII in the 2021 AMR Benchmark report.

C.1.1 Filed to register on-patent medicines in 30 access countries
Johnson & Johnson performs above average, filing its one relevant on-patent medicine for registration in 30 access countries, including eight LICs. The medicine is the MDR-TB medicine bedaquiline (Sirturo®). Johnson & Johnson publicly discloses on its company’s website where bedaquiline was filed for registration.

C.1.2 Filed to register off-patent/generic medicines in 29 access countries on average
Johnson & Johnson performs above average, filing all its three sample off-patent/generic medicines for registration in 29 access countries on average. All its three sample products are filed for registration in at least one LIC.

C.2.1 Several strategies to expand access to its on-patent medicine
Johnson & Johnson performs above average. It aims to expand access to its one relevant on-patent medicine in access countries through tenders, patient assistance programmes, access price settings and public or private partnerships. It collaborates with the GDF-Stop TB Partnership to provide 100 mg bedaquiline at a global access price of USD 340 per 6-month treatment course to GDF-eligible countries. The GDF-Stop TB Partnership also provides the paediatric formulation of bedaquiline (20 mg) at a price of USD200 per 6-month treatment course. Johnson & Johnson provides evidence of patient reach and geographic reach for all its reported approaches. It publicly commits to providing its MDR-TB medicine to a cumulative 700,000 patients worldwide by 2025. Bedaquiline is available in all 30 WHO high-burden countries for MDR-TB.

C.2.2 Limited information on strategies to expand access to off-patent/generic medicines
Johnson & Johnson has an average performance. It has set equitable tiered-pricing principles and publicly states to apply equitable pricing policies to its antifungal itraconazole and antibiotic levofloxacin. Johnson & Johnson provides evidence of patient reach and geographic reach for two of its three relevant products in scope. Details were provided under the basis of confidentiality.

C.3 Several strategies to ensure continuous supply
Johnson & Johnson performs above average, with strategies reported in all four areas assessed. It ensures accurate demand planning and data sharing by forecasting demand of bedaquiline (Sirturo®) based on local tender patterns and utilisation trends in high burden MDR-TB countries, distributor demand forecasts and global donor grant budgeting cycles. It mitigates against shortage risks by keeping a buffer stock for APIs and finished products. Both bedaquiline API and finished product are manufactured in India with flexibility to scale production. It reports several capacity building or technology transfer initiatives including a technology transfer for the formulation, filling, and packaging processes of bedaquiline including with Pharmstandard (Russia). It mitigates substandard and falsified products by having a dedicated team. It uses packaging security features and digital technologies to detect illicit trade.

Stewardship

Comprehensive COI mitigation strategies in place for its educational programmes
Engages in sales practices but does not engage in marketing practices to address appropriate use
Makes two types of brochure and/ or packaging adaptations to facilitate appropriate use by patients
Active in one AMR surveillance programme; shares raw data in a restricted manner

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally

C.4 Comprehensive COI mitigation strategies in place for its educational programmes
Johnson & Johnson performs strongly in conflict of interest (COI) mitigation for the five AMR-related educational programmes for HCPs assessed by the Benchmark. To mitigate COI for all five programmes, it provides financial resources to independent third parties (The Union, the Chinese and Indonesian governments) to carry out the programme.

C.5 Engages in sales practices but does not engage in marketing practices to address appropriate use
Johnson & Johnson performs above average in sales practices. It does not deploy any sales agents to promote bedaquiline (Sirturo®) to healthcare professionals except in one country. However, for the remaining antibacterial and/or antifungal medicines it does not report whether it decouples incentives for sales agents from sales volumes to help prevent the inappropriate use of such medicines. Johnson & Johnson does not engage in marketing practices that aim to address the appropriate use of its antibacterial and/or antifungal medicines as its marketing materials do not reflect emerging resistance trends or include treatment guidelines for healthcare professionals.

C.6 Makes two types of brochure and/or packaging adaptations to facilitate appropriate use by patients
Johnson & Johnson adapts brochures and packaging to facilitate the appropriate use of bedaquiline (Sirturo®) by patients. Johnson & Johnson performs well, taking account of language and adherence to treatment. It produces a package insert with information in four languages to streamline distribution. Further, it packaged a 6-month treatment regimen in a single bottle to facilitate patient adherence to treatment.

C.7 Active in one AMR surveillance programme; shares raw data in a restricted manner
Johnson & Johnson runs the multinational Drug Resistance Emergence Assessment in MDR-TB (DREAM) programme, which is focused on resistance against bedaquiline (Sirturo®) in 11 countries and has been running since 2015. Johnson & Johnson shares the raw data (from its clinical trials) through the Yale University Open Data Access (YODA) platform, which can only be accessed via approval through an independent scientific committee.