Johnson & Johnson
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Johnson & Johnson is one of the leaders when compared with other large research-based pharmaceutical companies in scope, driven by strong performances in Research & Development, Manufacturing & Production and Appropriate Access & Stewardship, largely centred around tuberculosis- related activities. The company has one of the largest antimicrobial R&D pipelines of the large research-based pharmaceutical companies in scope: 48** projects, of which 15** target priority pathogens, including one novel antimalarial candidate and at least three new vaccine candidates. It has access and stewardship provisions in place for some latestage candidates. The company discloses a comprehensive environmental risk-management strategy, which includes discharge limits and reportedly applies to all Johnson & Johnson’s third-party suppliers of antibiotic APIs and drug products. It has filed its three newest antibiotics for registration in some countries in scope.* It also reports equitable pricing strategies for some antibiotics, as well as multiple steps to improve supply chain efficiency. In stewardship, Johnson & Johnson engages in several tuberculosis-related educational programmes aimed at healthcare professionals, taking action to mitigate conflict of interest in these programmes. It engages in tuberculosis-related surveillance programmes, and collaborates and shares its data with public health authorities.
Sales & operations
Johnson & Johnson is a large research-based pharmaceutical company with operations in three segments: consumer healthcare, pharmaceuticals and medical devices. Its pharmaceuticals segment focuses on therapeutic areas such as cardiovascular health and metabolism, immunology, infectious diseases and vaccines, neuroscience and oncology. The company sells antimicrobial medicines or vaccines in 108 countries globally, 38 of which are low- to middle-income countries.* Johnson & Johnson’s vaccines are developed and produced by Janssen Vaccines & Prevention BV (part of Janssen Pharmaceutical Companies), which divested its oral typhoid and oral cholera vaccines to PaxVax and Valneva in 2014 and 2015 respectively.
Johnson & Johnson markets at least 22 antimicrobial medicines, seven of which are listed on the WHO EML (Section 6). Five of the company’s antimicrobial medicines are antibiotics. This includes levofloxacin (Elequine®, Levaquin®), listed on the EML’s Watch group, and bedaquiline (Sirturo®), included in the EML’s complementary list of reserve second-line drugs for the treatment of multidrug-resistant tuberculosis. Out of the remaining 17 medicines, six target HIV, two are used in the treatment of hepatitis C, five are antifungals and four are anthelminthics or antiprotozoals. The company has two vaccines on the market: Quinvaxem®, indicated for protection against five major childhood infectious diseases, and Hepavax-Gene®, a recombinant vaccine against hepatitis B. Johnson & Johnson reports that these are being phased out, citing availability of other products.
Plan ahead for access and stewardship during R&D. Johnson & Johnson has stated a commitment to ensure access and stewardship plans are in place for all of its candidates in the pipeline. It can ensure that this commitment is followed through with specific plans applying to all of its candidates in late-stage clinical development.
Improve transparency regarding environmental risk. Johnson & Johnson can share more information on how it manages environmental risk, e.g., the company can publish information regarding the levels of antibiotic discharge. Currently Johnson & Johnson discloses several policy documents regarding its environmental risk-management strategy.
Expand on stewardship activities. Johnson & Johnson engages in the DREAM surveillance programme, covering first- and second-line anti-tuberculosis medicines. The company can consider to expand this to more countries, e.g., in sub-Saharan Africa, and ensure data from such programmes is made publicly available. The company does not report stewardship activities for other antibiotics and can consider such activities for these antibiotics as well.
Improve access through the registration of new antibiotics. Johnson & Johnson can improve access in low- and middle-income countries* by filing its antimicrobials, particularly bedaquiline (Sirturo®) for registration in these countries. Johnson & Johnson has currently filed to register this product in 23 countries in scope.*
A. Research & Development
48 projects,15 target priority pathogens
A.1 Comparatively high antimicrobial R&D investments.
Johnson & Johnson reports investments in antimicrobial R&D in 2016, which are high compared to other large research-based pharmaceutical companies in the Benchmark. However, the Benchmark is not able to publish further information, as all details were provided on the basis of confidentiality.
A.2.1-2.3 Fifteen R&D projects that target priority pathogens, including one novel clinical antimalarial medicine.
Johnson & Johnson has 48** antimicrobial R&D projects in its pipeline, 23** of which are in clinical- stage development. Fifteen** of the company’s projects target priority pathogens. Ten of these are in clinical-stage development, making it the second-largest clinical-stage pipeline that targets priority pathogens, among the large research-based pharmaceutical companies assessed by the Benchmark. These ten projects consist of two medicines, three vaccines and five** adaptations to existing pharmaceuticals, including the adaptation of its anti-tuberculosis medicine bedaquiline (Sirturo®) for paediatric use. One of the investigational medicines is the antibiotic cadazolid, an oxazolidinone-quinolone hybrid targeting C. difficile, which was adopted through the acquisition of Actelion in 2017 and is now in Phase III of clinical development. The other is a novel antimalarial medicine, a dihydrofolate reductase inhibitor, in Phase I clinical development. The company is collaborating with ViiV Healthcare on the combination of its HIV/AIDS medicine rilpivirine (Edurant®) with ViiV Healthcare’s HIV/AIDS medicines: dolutegravir (Tivicay®)/rilpivirine (Edurant®) combination, as well as a cabotegravir/rilpivirine (Edurant®) long-acting nanosuspension for injection. The company has two vaccines in clinical development targeting HIV, and a third vaccine targeting multidrug-resistant extra-intestinal E. coli(specifically, targeting the four most prevalent serotypes resistant to at least three antibiotics). No vaccines currently exist for either pathogen.
A.3 Three R&D projects being developed with public partners, including two PDPs.
Johnson & Johnson is developing three R&D projects in its priority pathogen pipeline through public-private partnership. The company is developing an HIV vaccine in clinical stage through a consortium of partners, including, the National Institutes of Health (NIH), the Bill & Melinda Gates Foundation, the International AIDS Vaccine Initiative (IAVI), the United States Military HIV Research Program (MHRP) and the Beth Israel Deaconess Medical Center (BIDMC), among others. Additionally, the company is developing an antimalarial medicine through a PDP with the Medicines for Malaria Venture (MMV).
A.4 Access and stewardship provisions in place for some late-stage candidates.
Johnson & Johnson reports that it commits to having access and stewardship provisions in place for all its candidates in development before regulatory approval. To the Benchmark, the company reports that it will expand the access and stewardship activities currently in place for bedaquiline (Sirturo®) to its paediatric formulation in Phase II development. This entails a managed access programme through the Global Drug Facility and its own subsidiaries, and medical education on the use of bedaquiline (Sirturo®) to paediatric healthcare professionals. In addition, Johnson & Johnson has access provisions in place for three other R&D candidates targeting priority pathogens in late-stage development, including its HIV vaccine candidate and the antiretroviral combinations, developed in collaboration with ViiV Healthcare. Johnson & Johnson is responsible for delivery of the long-acting injectable cabotegravir/rilpivirine (Edurant®) regimen to developing countries. Only one of the remaining four candidates in late-stage development (ExPEC4v vaccine) has an access commitment in place. For this indicator, countries in scope are 106 low- and middle-income countries where access to medicine is likely limited.
Pipeline targeting priority pathogens
B. Manufacturing & Production
B.1 Comprehensive environmental risk-management strategy.
Johnson & Johnson undertakes almost all environmental risk-management activities that the Benchmark examines. Namely, it applies an environmental risk-management strategy to minimise the impact of antibiotic manufacturing discharge. It includes auditing and limits on antibiotic discharge, for its own manufacturing sites and those of third-party manufacturers of antibiotic APIs and drug products. Johnson & Johnson states that its strategy applies to external waste-treatment plants, yet it also reports that it does not set discharge limits for these plants nor audits implementation of the strategy.
B.2 Limited transparency regarding environmental risk management.
Johnson & Johnson publishes elements of its environmental risk-management strategy on its website. It does not disclose audit results, or the discharge levels of antibiotics. The company also does not share the identities of its third-party suppliers of antibiotic APIs and drug products or external waste-treatment plants.
B.3 Commits to following GMP, including at 3rd-party sites.
Johnson & Johnson reports that it has mechanisms for maintaining a high quality of antibiotic production — namely following GMP standards. This commitment applies to its own manufacturing sites. Johnson & Johnson requires its third-party suppliers of drug products to apply the same quality standards to their production facilities.
C. Appropriate Access & Stewardship
C.1 Filed three newest antibiotics in some countries in scope.
Johnson & Johnson reports that it has filed its three newest antibiotics for registration in some countries in scope* (between 7–23 countries). Two of these antibiotics are licensed from Daiichi Sankyo for sale in Latin America only. Johnson & Johnson has filed these two antibiotics (introduced in 1990 and 1996) for registration in seven and ten of the countries in scope* in Latin America. Johnson & Johnson’s bedaquiline (Sirturo®) is the only product introduced in the past five years (2012) that has been filed for registration in more than ten countries in scope*. Indeed, it has been filed in 23 such countries. It is also worth noting that through the Global Drug Facility, more than 70 countries have approved importation of bedaquiline prior to regulatory approval.
C.2 Product-specific equitable pricing.
Johnson & Johnson discloses equitable pricing approaches for four of its seven highest-volume antimicrobial medicines: bedaquiline (Sirturo®), darunavir (Prezista®), mebendazole (®) and simeprevir (Olysio®). It applies inter-country equitable pricing to three of these (not mebendazole), and intra-country equitable pricing to bedaquiline, mebendazole and simeprevir. Its inter-country pricing policy for bedaquiline reflects countries’ ability to pay (measured by GNI per capita) and disease burden (of multidrug-resistant tuberculosis).
C.3 Taking multiple steps to improve supply chain efficiency.
Johnson & Johnson engages with PAHO, the Global Drug Facility, WHO and others to align supply and demand forecasting for three of its seven highest-volume antimicrobial medicines: bedaquiline (Sirturo®), darunavir (Prezista®) and mebendazole (Vermox®). It also has mechanisms in place (i.e., it maintains safety stocks) to respond efficiently in the event of stock-outs in countries in scope.* These mechanisms cover bedaquiline (Sirturo®), darunavir (Prezista®) and simeprevir (Olysio®).
C.4 Multiple activities in tuberculosis-related educational programmes.
Johnson & Johnson has provided tuberculosis-related stewardship information only. The company reports that it is involved in tuberculosis educational programmes for HCPs that include AMR stewardship and rational use of antibiotics, with conflicts of interest (COI) mitigation measures in place. The company collaborates with third parties such as the International Union against Tuberculosis and Lung Disease and USAID on the appropriate use of anti-tuberculosis drugs, pharmacovigilance and multidrug- resistant tuberculosis management. The company supports these initiatives with unrestricted educational grants, which ensures independent content development.
C.5 No active promotion of bedaquiline.
The Benchmark measures how companies address stewardship through appropriate promotion practices. Johnson & Johnson’s new anti-tuberculosis drug, bedaquiline (Sirturo®), is provided solely through national tuberculosis programmes and therefore does not require any marketing materials. The company reports that it does not deploy any sales organisations for the sale of Sirturo® in countries in scope.*
C.6 Implements packaging adaptation for bedaquiline to facilitate appropriate use.
The company collaborated with Stop TB Partnership to adapt bedaquiline (Sirturo®) packaging by creating a six-month presentation and a blister preparation of the medicine. The former aims to improve patient adherence to treatment in Directly Observed Treatment (DOT) programmes, while the latter aims to facilitate usage in different environmental conditions.
C.7 Engages with WHO reference laboratories and national tuberculosis programmes.
Johnson & Johnson runs one multi-country surveillance programme, focused on tuberculosis resistant trends. It engages numerous laboratories to support the surveillance of tuberculosis resistance trends via the Drug Resistance Emergence Assessment in multidrug-resistant tuberculosis programme (DREAM). Although results are to be published in peer-reviewed journals, the company is also sharing data with national tuberculosis programmes.
Animal Health & Diagnostics
Activities in this area are not scored by the Benchmark. This information is provided given the importance of animal health and diagnostics on the topic of AMR.
Johnson & Johnson reports that it is developing bedaquiline sensitivity diagnostic plates and panels that are to be deployed on the Becton Dickinson and Thermo Fisher Scientific Inc. lab infrastructure. In December 2015, Johnson & Johnson and the Foundation of Innovative New Diagnostics (FIND) entered into a collaboration for the discovery of point-of-care diagnostics for tuberculosis case detection, including multidrug- resistant strains. The company has also formed a partnership with Cue Inc. to develop an HIV viral load test on Cue’s Lab-In-A-Box molecular diagnostic platform. The technology is aimed to improve routine viral load testing of HIV/AIDS patients on antiretroviral therapy.
* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited
** Rilpivirine long-acting nanosuspension has been terminated after the period of analysis
† EML Section 6: Anti-Infective Medicines
§ FYE 1 January 2017