Merck & Co., Inc.
|Applicable indicator||Not applicable|
Merck & Co., Inc. is active in many important areas related to AMR, reflected in its good performance in certain areas of the Benchmark. Due to a lack of publicly available information and engagement with the Benchmark, it performs less well in areas evaluating depth of engagement in AMR. The company has a relatively small antimicrobial R&D pipeline: 16 projects of which nine target priority pathogens, including two new vaccine candidates. The company discloses an environmental risk-management strategy that reportedly also applies to all Merck & Co., Inc.’s third-party suppliers of antibiotic APIs and drug products. The company reports no information about setting discharge limits. Regarding access, Merck & Co., Inc. has not publicly disclosed where it has filed its newest antibiotics for registration. It has, however, publicly committed to engaging in equitable pricing for some antimicrobials. Regarding stewardship, the company reports that it engages in several AMR educational activities aimed at healthcare professionals. It has also established a long-running AMR surveillance programme.
Sales & operations
Merck & Co., Inc. (known as MSD outside of the US and Canada) is a large research-based pharmaceutical company with three business segments: pharmaceuticals, vaccines and animal health. The company sells its products in more than 140 countries worldwide. Its core therapeutic areas include infectious diseases and vaccines. In 2015, Merck & Co., Inc. acquired Cubist Pharmaceuticals for USD 9.5 billion, a company specialising in the development and supply of antibiotics to treat infections arising in acute care settings, frequently caused by drug-resistant bacteria. At the end of 2016, Merck & Co., Inc. and Sanofi Pasteur ended their vaccines joint venture in Europe (Sanofi Pasteur MSD, established 1994) to independently manage their product portfolios.
According to publicly available data, Merck & Co., Inc. markets at least 19 antimicrobial medicines, nine of which are listed on the WHO EML (Section 6). Nine of the company’s antimicrobials are antibiotics, with four listed on the WHO EML (Section 6), including two in the EML’s Reserve group: daptomycin (Cubicin®) and ceftolozane/ tazobactam (Zerbaxa®). Out of the remaining ten medicines, seven are antivirals used for treating HIV/AIDS or hepatitis C, two are antifungals, and one is an anthelminthic. The company also markets an antibody, bezlotoxumab (Zinplava®), indicated, in conjunction with antibacterial therapy, to reduce recurrence of of C. difficile infections. The company’s vaccines portfolio includes both traditional childhood immunisations (such as a measles, mumps and rubella combination vaccine) and newer additions, such as Gardasil®/ Gardasil®9 for use against certain strains of human papillomavirus (HPV), and RotaTeq® for use against rotavirus.
Plan ahead for access and stewardship during R&D. Merck & Co., Inc. discloses no information regarding access and stewardship provisions for its candidates. Merck & Co., Inc. can develop and implement access and stewardship plans for all its candidates in late-stage clinical development.
Expand environmental risk-management strategy. Merck & Co., Inc. can ensure that it sets and applies discharge limits for antibiotic manufacturing. The company publishes its environmental risk-management policies that it applies to both its own and third-party manufacturing sites.
Improve access through the registration and affordability of new and existing antimicrobials. Merck & Co., Inc. discloses information on its registration approach for six antimicrobials, including antimicrobial medicines and vaccines. It can seek opportunities to ensure greater access in more low- and middle-income countries through the registration of new and existing antimicrobials, and ensure that these are priced affordably.
Expand on stewardship activities. Merck & Co., Inc. engages in educational activities for healthcare professionals on AMR globally. It also developed the SMART surveillance programme, which has been measuring resistance trends globally since 2002. The company can collaborate with public health authorities, and can ensure that the data is made publicly available via an open database. Merck & Co., Inc. can also engage in improving appropriate promotion practices.
A. Research & Development
16 projects, 9 target priority pathogens
A.1 No information on antimicrobial R&D investments.
Merck & Co., Inc. reports no information on its antimicrobial R&D investments.
A.2.1-2.3 Nine candidates targeting priority pathogens.
Merck & Co., Inc. does not publicly report information on candidates in Phase I development. According to publicly available information, the company has 16 antimicrobial R&D projects in its pipeline, including ten projects in clinical-stage development. Nine of the company’s projects target priority pathogens. Although its priority pathogen pipeline is relatively small compared to other large research-based pharmaceutical companies assessed by the Benchmark, eight of the nine projects that target priority pathogens are focused on multidrug-resistant bacteria (the remaining project targets HIV). This includes the adaptation of the existing medicines ceftolozane/tazobactam (Zerbaxa™) and tedizolid (Sivextro®) for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP). Its clinical-stage projects consist of a next-generation HIV/AIDS medicine, a ß-lactamase inhibitor targeting gram-negative bacteria, and a vaccine against S. pneumoniae.
A.3 Some preclinical R&D projects being developed with public partners.
Merck & Co., Inc. is developing three preclinical R&D projects in its priority pathogen pipeline through public-private partnerships (including non-profit organisations). It is developing a vaccine for shigellosis through its joint venture with the Wellcome Trust called Hilleman Laboratories. Hilleman Laboratories focuses on developing affordable vaccines and addressing R&D gaps for low-resource settings. In addition, the company collaborates with the University of Granada and the regional government of Andalusia, Spain, in a research alliance called Medina Discovery, which focuses on the screening and validation of drug targets for infectious diseases. Merck & Co., Inc. also collaborates with Rutgers University, USA, for the discovery of novel antimicrobial medicines, with funding from the National Institutes of Health (NIH).
A.4 Access and stewardship commitment in place.
Merck & Co., Inc. has a Global AMR Action Plan which describes the company’s commitment to support access and stewardship for its novel antimicrobials portfolio. It has signed the Davos Declaration, which includes a general commitment to ensuring access to antimicrobial medicines and vaccines, and to support the appropriate and responsible use of these products.
Pipeline targeting priority pathogens
B. Manufacturing & Production
B.1 Environmental risk management at own and external sites.
Merck & Co., Inc. has an environmental risk-management strategy to minimise the impact of antibiotic manufacturing discharge. The strategy applies to its own manufacturing sites and to third-party manufacturers of antibiotic APIs and drug products. The company commits to auditing the implementation of this strategy at both types of site. There is no evidence of the strategy being applicable to external waste-treatment plants. The company reports no information about setting discharge limits.
B.2 Limited transparency regarding environmental risk management.
Merck & Co., Inc. 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.
Merck & Co., Inc. 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. Merck & Co., Inc. requires its third-party suppliers of drug products to apply the same quality standards to their production facilities.
C. Appropriate Access & Stewardship
C.1 Some newest antibiotics filed in some countries in scope.
Merck & Co., Inc. has filed some of its newest antibiotics, cilastatin/imipenem (Primaxin®) and ertapenem (Invanz®), for registration in some countries in scope.* However, further details are not publicly available.
C.2 Makes general commitment to equitable pricing.
Merck & Co., Inc. discloses a general (not product-specific) inter- and intra-country equitable pricing approach covering countries in scope.*
C.3 Some insight into approach to supply chain efficiency.
Merck & Co., Inc. does not disclose how it works with stakeholders (e.g., governments, procurers) to align supply and demand for its highest- volume antimicrobial medicines, specifically to prevent or minimise stock-outs in countries in scope.* It does, however, publish a set of Supply Chain Standards, including the capacity to respond to changing demand. The company also does not report on whether it has processes in place to respond to stock-outs in countries in scope.
C.4 Multiple activities in AMR-related educational programmes.
Merck & Co., Inc. is involved in educational programmes for HCPs that include AMR stewardship and rational use of antibiotics, with conflicts of interest (COI) mitigation measures in place. Programmes include its recently launched knowledge platform that provides direct links to high-quality information and educational resources on AMR. The company also reports working with relevant stakeholders (e.g., CDC and a Colombian public health institute) to develop stewardship guidelines and programme metrics and support antimicrobial stewardship programmes in hospitals.
C.5-C.6 No information regarding brochure and/or packaging adaptations, or appropriate promotion practices.
Merck & Co., Inc. does not report any language, cultural or literacy adaptations made to its brochures or packaging that would promote appropriate use. Furthermore, the company does not report any appropriate promotion practices in its marketing materials or decoupling its sales force’s incentives from volume of antibiotic sales.
C.7 International programme for AMR surveillance.
Merck & Co., Inc. runs a global surveillance programme focused on AMR trends, namely the “Study for Monitoring Antimicrobial Resistance Trends” (SMART), which has a global scope and has been measuring resistance trends in intra-abdominal samples since 2002. The data has been published in several peer- reviewed publications over the years. The company also publicly commits to providing updated data by country and region. The company also engages in two other AMR-related surveillance programmes, the Program to Assess Ceftolozane- Tazobactam Susceptibility (PACTS) and Surveillance of Tedizolid Activity and Resistance (STAR).
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.
Merck & Co., Inc. is the only company in scope that is involved in antibiotics for use in animal health. The company conducts research to develop alternatives to antibiotics for animal use and to facilitate the appropriate use of antibiotics in animals. Merck & Co., Inc. runs a surveillance programme that monitors the emergence of bacterial resistance to Merck & Co., Inc. Animal Health antibiotics. Additionally, the company reports that it provides veterinarians, commercial production operations, farmers, ranchers and feed companies with guidelines on resistance management, appropriate dosage, and length of usage to support the appropriate use of antibiotics.
* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited
† EML Section 6: Anti-Infective Medicines
§ FYE 31 December 2016
|| For 16 top-selling products