AMR Benchmark Opportunities: progress update

Research-based pharmaceutical company

Merck & Co, Inc (MSD)
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?

Develop and disclose project-specific plans to improve

Merck & Co, Inc (MSD) did not report any updates on thisaccess and stewardship for R&D projects in late-stage

Opportunity. Additionally, the company does not report any

development.

project-specific access and stewardship plans for its late-

MSD reports a commitment to expand access through broadstage antibacterial or antifungal R&D projects including theregistration, including in LMICs, and supports appropriate

S. pneumoniae vaccine V116 currently in Phase III of clinicaland responsible use of their antibacterial medicines. MSD

development.

can develop project-specific access and stewardship plans
for all its late-stage R&D projects. For example, for its S.
pneumoniae vaccine V116 it can commit to fast registrationin countries with the highest burden of disease, and developa pricing strategy that considers the ability to pay of target
populations in those countries.
Expand its environmental risk-management strategy

MSD continues to disclose implementing the AMR Industry

to suppliers and ensure compliance at all sites with

Alliance guidelines at its own and supplier sites. The com-antibacterial discharge limits by tracking and publicly

pany does not report any developments on the number of

disclosing progress and results.

its own and supplier sites that comply with discharge limits.

MSD reports to set limits and to quantify the discharge lev-

Similar to 2021, MSD does not publicly disclose audit

els at its own sites. It can extend this practice to suppliers’

results containing antibacterial discharge levels for both its

sites and track compliance of both own and suppliers’ sites

own sites and suppliers’ sites. Furthermore, the company

with discharge limits and publicly disclose the results. To

does not disclose the names and locations of its suppliers.

provide clear evidence of its progress, it can publicly reportcompliance at all sites. 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 andwaste-treatment plants for increased transparency.
Expand registration of medicines and vaccines to more

MSD did not report any progress on this Opportunity. The

access countries.

company sought and secured inclusion of ceftolozane/tazo-

MSD reports that ceftolozane/tazobactam (Zerbaxa®) was

bactam (Zerbaxa®) in the 2023 World Health Organization

filed for registration in 25 access countries. It can file its(WHO) Model List of Essential Medicines (EML) as a

antibacterial and antifungal medicines and vaccines (e.g.

Reserve antibiotic. This antibiotic is effective against

Zinplava™, Recarbio™ and Pneumovax 23) in more coun-

multi-drug resistant bacteria, including difficult-to-treat

tries, including low-income countries, with a high burden of

infections caused by carbapenem resistant Pseudomonasdisease. It can improve disclosure on where its medicines

aeruginosa.

are registered and made available.
Fully decouple incentives for sales agents from sales

MSD did not report any progress on this Opportunity.

volumes.
MSD runs a pilot in the UK, in which it fully decouples incentives for sales agents from sales volumes of antibacterial
medicines sold in UK hospitals. It can expand this practiceto all countries it operates in and to all antibacterial andantifungal medicines.

15

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?

Publicly share raw data from surveillance programmes.

MSD has shared the anonymised raw data from the SMART

MSD runs multiple AMR surveillance programmes. It

surveillance programme to the AMR Register, an initiative

can publicly share raw data from these surveillance pro-by Vivli.

grammes: SMART, PACTS and STAR - anonymised and in

As with all datasets available on AMR Register, the data-a freely accessible format. Additionally, either MSD or theset is available for researchers to access after submitting amanaging partners can publicly share raw data from therequest, which is then subjected to a review by Vivli and the

CANWARD and BSAC surveillance programmes.

relevant company before data is shared.
MSD extended this data-sharing commitment fromthe SMART programme to the 2022 Global Research on
Antimicrobial Resistance (GRAM) report, which included
single drug-resistance profiles.
Data from the two other surveillance programmes MSD
runs, have not been shared with the AMR Register, nor has
the company reported public disclosure of the raw datafrom these programmes.

16

Antimicrobial Resistance Benchmark 2021

MRC

Overall Performance
2020

2021

49% 46%▼

Access to Medicine Foundation

Merck & Co, Inc (MSD)
Large R&D-based pharmaceutical company
Stock exchange: NYSE • Ticker: MRK • HQ: Kenilworth, NJ, US • Employees: 74,000

MRC
PERFORMANCE

Performance in the Benchmark

MSD performs below average overall in its evaluated Research Areas0%

compared to the other large research-based pharmaceutical companies
in scope.
R&D: MSD is a middle-performing company in the R&D Research Area.
Its 13-project pipeline has three vaccines. Three projects target critical
and/or urgent pathogens. MSD has made a general commitment toexpanding access to its products.
Responsible Manufacturing: Performs well. Reports environmental risk-

Appropriate Access: Performs less well. Discloses limited information

product.
Stewardship: Middle-performing. It fully decouples incentives for sales
agents from antibacterial sales volumes in the UK. It publicly shares
aggregated results of its surveillance programmes. It reports broad
conflict of interest mitigation for its educational programmes. It does not

50%

100%

Points47%

R&D

14/ 3073%

Manufacturing

11/ 1529%

Access

10/ 3555%

Stewardship0%

11/ 2050%

100%

How Merck & Co was evaluatedon registration filings for its on- and off-patent products. Discloses somestrategies to expand access and ensure continuous supply of its relevant

46/ 100

Performance by Research Area

management strategy for own sites and suppliers; quantifies discharge
levels at own sites.

Points46%

Overall score

A R&D

1

2.1 2.2 2.3 2.4

3

●

●

●

●

1

2

3

B Manufacturing ●

●

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3

C Access

●

●

●

4

5

6

7

C Stewardship

●

●

●

●

●

●

●

●

adapt brochures of packaging for patients.
● ● ● Scored●

Not scored

OPPORTUNITIES FOR MSD

CHANGES SINCE 2020

Develop and disclose project-specific plans to improve access and stewardship for R&D projects• In May 2020, MSD’s technology and services

in late-stage development. MSD reports a commitment to expand access through broad registra-provider ILUM Health Solutions combinedtion, including in LMICs, and supports appropriate and responsible use of their antibacterial medi-with UPMC Infectious Disease Connect Inc.

cines. MSD can develop project-specific access and stewardship plans for all its late-stage R&D pro-to share expertise and resources to enhance

jects. For example, for its S. pneumoniae vaccine V116 it can commit to fast registration in countries

patient care, optimise antimicrobial therapy

with the highest burden of disease, and develop a pricing strategy that considers the ability to payof target populations in those countries.

and reduce potential for drug resistance.
• In 2020, MSD expanded the functionality of

Expand its environmental risk-management strategy to suppliers and ensure compliance at all

the global SMART surveillance website, and itsites with antibacterial discharge limits by tracking and publicly disclosing progress and results.

will put a mechanism in place for researchers

MSD reports to set limits and to quantify the discharge levels at its own sites. It can extend thisto request access to anonymised raw data.

practice to suppliers’ sites and track compliance of both own and suppliers’ sites with discharge
limits and publicly disclose the results. To provide clear evidence of its progress, it can publicly
report compliance at all sites. 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.
Expand registration of medicines and vaccines to more access countries. MSD reports thatceftolozane/tazobactam (Zerbaxa®) was filed for registration in 25 access countries. It can file its
antibacterial and antifungal medicines and vaccines (e.g. Zinplava™, Recarbio™ and Pneumovax
23®) in more countries, including low-income countries, with a high burden of disease. It can
improve disclosure on where its medicines are registered and made available.
Fully decouple incentives for sales agents from sales volumes. MSD runs a pilot in the UK, in which
it fully decouples incentives for sales agents from sales volumes of antibacterial medicines sold in
UK hospitals. It can expand this practice to all countries it operates in and to all antibacterial andantifungal medicines.
Publicly share raw data from surveillance programmes. MSD runs multiple AMR surveillance programmes. It can publicly share raw data from these surveillance programmes: SMART, PACTS andSTAR - anonymised and in a freely accessible format. Additionally, either MSD or the managing partners can publicly share raw data from the CANWARD and BSAC surveillance programmes.

* All companies were assessed based ondata submitted to the Benchmark in thecurrent and previous periods of analysis, as well as information the companies have made publicly available, or thatare accessible through other sources.
For the 2021 Benchmark, MSD declined
to submit data to the Antimicrobial
Resistance Benchmark.

10

Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONSMRCNet sales by business segment

Therapeutic areas: Cardiovascular, Diabetes, Hospital acute care,2019 4,393

Immunology, Neuroscience, Oncology, Vaccines, Virology.

2020 4,703

Business segments: Animal health, Pharmaceuticals

0

Product categories: Animal health, Innovative medicines, Vaccines
M&A since 2020: None in the antibacterial and/or antifungal sectors

41,751

175

43,021
10,00020,000

Animal Health30,000

Pharmaceuticals

23

40,00050,000
Other segment sales mn USD

MRC
Net sales by region
201920,5192020

21,0270

10,00012,707
13,60020,00030,00040,00050,000Asia Pacific (other than China and Japan) mn USD
Latin America
Other

United States
Europe, Middle East and Africa
China
Japan

PIPELINE for pathogens in scope

PORTFOLIO for pathogens in scope

Pipeline size: 13 projects targeting pathogens in scope** (10 antibacterial

Comparatively small portfolio: At least 19 products: 12 antibacterial medi-

medicines; 3 antibacterial vaccines).

cines; 4 antibacterial vaccines; 3 antifungal medicines

Development stages: 2 clinical projects, including V116, a Phase II pneumo-

On-patent medicines: 6 (bezlotoxumab, ceftolozane/tazobactam, fidax-

coccal vaccine; and 7 discovery/preclinical projects.

omicin, imipenem/cilastatin/relebactam, posaconazole, tedizolid)

Novelty: 0 novel clinical-stage medicine projects.

On-patent vaccines: 3 (Liquid PedvaxHIB®, Pneumovax® 23, Vaxelis®)‘Critical’ and/or ‘urgent’ pathogens: 3 projects, relebactam/imipenem/

Off-patent/generic medicines: 7 of 10 were selected for analysis** (ben-cilastatin (Recarbrio™) targets carbapenem-resistant Enterobacteriaceae.

zathine benzylpenicillin [A], caspofungin [F], clotrimazole/betamethasone

It is active against Klebsiella pneumoniae carbapenemase (KPC), but[F], daptomycin [R], ertapenem [W], gentamicin [A], moxifloxacin [W])not metallo-beta-lactamase (MBL)- producing Enterobacteriaceae.

AWaRe medicines***: 2 Access group; 4 Watch group; 2 Reserve group

Fidaxomicin (Dificid®) targets C. difficile.
Regulatory approvals: 4 approvals. In July 2019, Relebactam/imipenem/

MRC
Pipeline for priority pathogens

cilastatin (Recarbrio™) was approved by the FDA for the treatment ofcomplicated urinary tract infections (cUTI), including pyelonephritis, andcomplicated intra-abdominal infections (cIAI). In June 2020, Recarbrio™
received supplemental approval by the FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)

30ugate vaccine (15-valent) was approved by the FDA.

1020● Antibacterial vaccine● Antibacterial medicine● Antifungal vaccine● Antifungal medicine

MRC
Products on the market

in adults. In January 2020, Fidaxomicin (Dificid®) paediatric adaptation wasapproved by the FDA. In July 2021, Vaxneuvance™, pneumococcal coni-

10

4
0

12
10

3
20

● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

PERFORMANCE BY RESEARCH AREAA

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

Pipeline targeting priority pathogens: 13 As at 24 September 2021
Discovery

Pre-clinicalProtein synthesis inhibitor [M. tuberculosis]♦ Shigella spp. vaccine

Partnership with Orchid
Pharma, India - Bacteria & fungi

Compound screening
ALIS (MOA) [M. tuberculosis]
ATP synthase inhibitor
1 mo GLP safety studies[M. tuberculosis]
In vivo preclinical PK/PD
dose ranging project [M.
tuberculosis]
Diarylquinoline (TBAJ587) [M. tuberculosis]

Phase I

Phase II

Phase III

Approval♦ S. pneumoniae vaccine
adult (V116)

Sivextro® - additional
population: paediatric[Gram positive bacteria]♦ S. pneumoniae vaccine(Vaxneuvance™)[FDA/Jul-21]†
Fidaxomicin (Dificid®) [C.
difficile] [FDA: Jan-20]:
additional population:
paediatricRelebactam/imipenem/
cilastatin (Recarbrio™)[Enterobacteriaceae][FDA/Jul-19] cUTI,
including pyelonephritis
and cIAI[FDA/Jun-20] HABP/
VABP** 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.

♦ = Vaccine
GLP = Good Laboratory practice
PK/PD = Pharmacokinetic/pharmacodynamiccUTI = Complicated urinary tract infection
cIAI = Complicated intra-abdominal infection
HABP = Hospital-acquired bacterial pneumonia
VABP = Ventilator-associated bacterial pneumonia† Approved after the end of the period of analysis.

11Antimicrobial Resistance Benchmark 2021

A.1

Investments in R&D

Access to Medicine Foundationfrom the FDA for the treatment of complicatedControl and Prevention (CDC). Relebactam/imi-

MSD does not disclose publicly, or to theurinary tract (cUTI) and intra-abdominal infec-

penem/cilastatin (Recarbrio™) targets carbap-

Benchmark, its R&D investments during 2019

tions (IAI). Recarbrio™ does not meet any ofenem-resistant Enterobacteriaceae, and fidax-

and 2020 in antibacterial and antifungal med-WHO’s innovativeness criteria. MSD has threeomicin (Dificid®) targets C. difficile.

icines and/or vaccines for pathogens in scope.

adaptive projects aiming, respectively, to extend

MSD has pledged USD 100 mn to the AMR

the indications of fidaxomicin (Dificid®), rele-

Action Fund over the next ten years.

bactam/imipenem/cilastatin (Recarbrio™) andtedizolid (Sivextro®).

A.2.1 Medium-sized pipeline

A.3

General commitments towards expanding access and affordability practices

MSD does not report any specific access or
stewardship plans for any of its six late-stage

The company has 13 projects targeting patho-

A.2.3 Three vaccine candidates

medicine and vaccine projects targeting path-gens in scope: 10 medicines and three vaccines,

MSD reports three vaccine projects in its pipe-

ogens in scope. Four out of six projects have

all targeting bacterial pathogens. Out of the 13

line. It includes one innovative candidate in pre-ongoing clinical trials in access countries.‡ The

projects, two are in discovery stage, five are inclinical development targeting Shigella spp. andcompany has made a general commitment about

preclinical development, two are in clinical devel-

two adaptive vaccine candidates targeting S.

registering its products in LMICs, expanding

opment and four received marketing approval.

pneumoniae: V114 and V116.

access through broad registration and improving

A.2.2 MSD extending indications for their

A.2.4 Two candidates targeting critical and/or

affordability. MSD supports the appropriate andantibacterials

urgent priorities

MSD’s clinical-stage medicine pipeline consists

MSD has two medicines in its R&D pipeline tar-of both innovative and adaptive R&D projects.

geting pathogens defined as ‘critical’ by WHO’s

Relebactam/imipenem/cilastatin (Recarbrio™)

list of priority pathogens and/or characterised

received first marketing approval in July 2019as ‘urgent’ threats by the US Centers for Disease

responsible use of its antibacterial and antifungal medicines by supporting hospitals globally tostrengthen their AMS programmes.

B

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

B.1

Environmental risk-management for own

mental standards. It reports auditing externalsites and suppliers; sets limits at own

private and public waste-treatment plants but nosites and suppliers

details on audit parameters are provided. It also

MSD reports a strategy to minimise the envi-

does not report whether conservative measuresronmental impact of wastewaters and solidfor effluents sent to external public wastewater

waste from antibacterial manufacturing at its

plants are employed.

sites, including audits at least every 1-2 years. It

discharge from its own or suppliers’ sites.
B.3

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

MSD reports that its own sites and suppliers
have a system to maintain high-quality antibac-

Publicly discloses some information on

terial production, consistent with international

environment for all antibacterials manufactured

environmental risk management and

GMP standards. This includes risk-based inter-at its sites, based on PNECs to limit AMR, as rec-commitment to setting limits

nal audits and tracking of corrective and preven-ommended the AMR Industry Alliance. It also

MSD publishes some components of its envi-

tive actions. It also requires its suppliers to audit

reports quantifying discharge levels but there isronmental risk-management strategy. It is atheir own suppliers. The Benchmark found nono information on the methods used and compli-

member of the AMR Industry Alliance, which

requests for official corrective action from theance with set limits.

publishes a list of recommended antibacte-

FDA or EMA related to non-conformities with

MSD requires third-party suppliers of anti-

rial discharge targets. MSD publishes its com-cGMP at MSD’s own sites or any subsidiaries thatbacterials to follow similar standards, including

mitment to setting these targets. It does not

manufacture antibacterials.

on-site audits and limits based on PNECs. Therepublish: (1) the results of environmental audits,

is limited information whether it requests andwhether conducted at its own sites, the sites

reviews the discharge levels of its suppliers.

of suppliers or external private and public

reports setting discharge limits in the receiving

MSD expects external private waste-treatment plants to comply with its general environ-C

B.2

waste-treatment plants; (2) a list of these suppliers and plants; or (3) the levels of antibacterial

APPROPRIATE ACCESS & STEWARDSHIP – ACCESS

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries‡
C.1.1

Limited information on registration fil-of filing its seven relevant off-patent/generic

patents in low-income countries. MSD does notings for on-patent medicines

medicines for registration in access countries.

provide evidence of patient reach and geographic

MSD performs below average as it does not disclose where it has filed five of its six relevant
on-patent medicines for registration. However,reach in low- and middle-income countries.
C.1.3 No information on registration filings foron-patent vaccines

it publicly reports that its on-patent medicine,

MSD reports no evidence of filing its three rel-ceftolozane/tazobactam (Zerbaxa®), a reserve

evant on-patent vaccines for registration in

antibiotic used to treat intra-abdominal infec-

access countries.

tions, acute pyelonephritis, cUTIs and hospital-acquired pneumonia, was filed for registration in 25 LMICs.

C.2.2 Limited information on strategies toexpand access to off-patent/generic
medicines
MSD’s performance is low as it discloses limited information on how it expands access to its

C.2.1 Limited information on strategies toexpand access to on-patent medicinesseven relevant off-patent/generic medicines. It
publicly reports to expand access through differ-

MSD performs below average. It expands accessential pricing and public or private partnerships

to its on-patent medicines in access countries

with governments, NGOs and distribution chan-ings for off-patent/generic medicines

through differential pricing and public or private

nels. MSD does not provide evidence of patient

MSD’s performance is low. It reports no evidence

partnerships and publicly commits not to enforce

reach and geographic reach.

C.1.2 Limited information on registration fil-‡ 102 low- and middle-income countries
where better access to medicine is mostneeded.

12

Antimicrobial Resistance Benchmark 2021

C.2.3 Limited information on strategies toAccess to Medicine Foundation

intra-country pricing strategies to allow for pricemedicines and vaccines. MSD has supply agree-

flexibility. MSD publicly commits not to enforce

ments with local manufacturing partners to

MSD performs below average as it discloses lim-

patents in low-income countries. MSD does

allow for local production of its vaccine. To miti-

ited information on how its expands access to its

not provide evidence of patient reach and geo-

gate against substandard and falsified products,

on-patent vaccines in access countries. It pub-graphic reach for its strategies.

MSD uses security features, has a dedicatedexpand access to on-patent vaccines

licly discloses having differential pricing andintellectual property policies, and participating in

anti-counterfeiting team in place, and raises
C.3

Limited information on strategies to

its vaccines, MSD takes into account the level of

MSD has an average performance. It publicly

economic development, the channel of distribu-

reports to ensure accurate demand planning andtion and the public health needs. It has inter- andcommits to maintaining a reliable supply of itsCpublic awareness.

ensure continuous supply

public or private partnerships. To set the price of

APPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

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

Broad COI mitigation strategies in placedecouples incentives for sales agents from sales

been running since 2002. MSD only sharesfor its educational programmes

volumes to help prevent the inappropriate use of

the aggregated results through peer-reviewed

its antibacterial and/or antifungal medicines.

open-access journal articles as well as on the

MSD performs well in the analysis of its top
five AMR-related educational programmes for

MSD engages in marketing practices thatonline SMART database, a restricted data

healthcare professionals in conflict of inter-

aim to address the appropriate use of its anti-

platform. Additionally, it is planning to makeest (COI) mitigation. To mitigate COI for threebacterial and/or antifungal medicines. Its mar-anonymised source data available for research-

programmes, it provides financial resources toketing materials reflect emerging resistanceers upon request through the SMART database.

independent third parties (CIDEIM, BSAC andtrends and/or include treatment guidelines for

For the remaining programmes, only the aggre-

the University of Dundee) to develop the pro-healthcare professionals: it has developed its

gated results are shared through peer-reviewed

gramme. One programme (developed by theStar of Stewardship principles in which all mar-open-access journal articles, as well as on ancompany) has all three COI mitigation strate-keting materials must include, e.g. specific indi-

open-access data platform for the CANWARD

gies looked for by the Benchmark: (1) content

cations, treatment duration and dose.

programme (a national programme managed byis developed by a third party independent fromthe company’s own marketing department; (2)the Canadian Antimicrobial Resistance Alliance).
C.6

Does not report adapting brochures and/or packaging to facilitate appropriate

participants are not provided financial or mate-use by patients

rial incentives (as it is a website); and (3) it does
not use branded materials. The remaining pro-

MSD does not report adapting brochures and/gramme has one COI mitigation strategy: it isor packaging to facilitate the appropriate use of

unclear whether content is developed inde-

its antibacterial and/or antifungal medicines bypendently from its marketing department or

patients.

whether it uses branded materials.
C.7
C.5

Engages in sales and marketing practices
to address appropriate use

Active in multiple AMR surveillance programmes; openly publishes aggregatedresults

MSD performs above average in sales prac-

MSD is active in multiple AMR surveillance pro-tices. It started a pilot in 2019 where it does

grammes. It runs the multinational SMART pro-not reward its sales agents based on antibacte-gramme, which is focused on respiratory infec-

rial volumes sold in UK hospitals. However, out-tions and complicated intra-abdominal and uri-side of this pilot MSD does not report whether itnary tract infections in 63 countries and has

13