AMR Benchmark Opportunities: progress update

Research-based pharmaceutical company

SanofiThis 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?

Expand breadth of R&D pipeline into more pathogens.

Sanofi has reported progress on its pipeline, with its conju-

Sanofi has antibacterial vaccines and medicines in late-stagegate pneumococcal vaccine candidate (SP0202) advancing

clinical development that target, e.g., S. pneumonia and M.

to Phase III in 2024.

tuberculosis. Sanofi can expand the focus of its pipeline to

In October 2023, Sanofi announced a development andtarget resistant pathogens for which R&D is limited, suchcommercialisation agreement with Johnson & Johnson for

as Campylobacter spp. and H. pylori. It can do so by invest-

ExPEC9V, a vaccine candidate for extraintestinal pathogenic

ing in in-house R&D, through acquisition or collaboration

E. coli, currently in Phase III of clinical development.

with other companies, or by joining existing public private
partnerships.

The company has further added vaccine projects to its
R&D pipeline that target bacteria not included in the priority
lists published by the US Centers for Disease Control andPrevention (CDC) and World Health Organization (WHO).
This includes a Cutibacterium acnes mRNA vaccine candidate moving to Phase I/II in 2023 and a chlamydia mRNA
vaccine candidate moving to Phase I/II in 2024.

Expand and tailor access and stewardship plans for late-

Sanofi’s conjugate pneumococcal vaccine candidate

stage R&D projects.

(SP0202/Skypac) is currently undergoing review under

Sanofi has both vaccines and medicines in late-stage clinical

Sanofi’s Global Access Plan commitment.

development. It can improve access to these new products,

The company did not report any further progress on its

by developing plans for registration, affordability andlate-stage R&D projects for bacteria that are included in thesustainable supply. For example, for their phase II vaccine,priority lists published by the CDC and WHO.

Skypac, Sanofi can develop equitable pricing plans that

Sanofi has acquired worldwide commercial rights toconsider ability-to-pay and apply supply chain best practices

ExPEC9v from Johnson & Johnson. It is too early for Sanofi

including buffer and safety stocks and shortage mitigation

and Johnson & Johnson to disclose access plans for the

strategies. In addition, Sanofi can expand its stewardship

ExPEC9V vaccine candidate.

plans for its medicine R&D projects by getting involved incomprehensive surveillance activities resistance trends
information to their products as well as other medicines
often given alongside them in the long multidrug treatments
required for this disease, and to do it in relevant geographical regions where limited evidence is available.
Ensure compliance with antibacterial discharge limits

Sanofi continues to report implementing the AMR Industry

at suppliers’ sites by tracking and publicly disclosing

Alliance guidelines. The company publicly reports that 72%

progress and results specific to antibacterials for allof its own manufacturing sites launched a programme tosites.

monitor, manage, and reduce pharmaceutical discharges.

Sanofi can quantify discharge levels at all suppliers’ sites

However, Sanofi does not report any developments on theand track compliance with set limits, as it does at own sites,

number of its own and supplier sites that are compliant withand publicly disclose the results. To provide clear evidence

voluntary discharge limits.

of its progress it can publicly report compliance at all sites.

Similar to 2021, Sanofi does not publicly disclose audit

Disclosure of information, including the results of audits andresults that specify antibacterial discharge levels of its own

antibacterial discharge levels of its own sites and suppliers’sites and suppliers’ sites. It also does not disclose the names

sites, is important. It can also publicly disclose the names

and locations of its suppliers.

and locations of its suppliers and waste-treatment plants forincreased transparency.

22

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?

Expand registration of antibacterial and antifungal

Sanofi did not report any specific developments regarding

medicines.

the registration filings of antibacterial and antifungal

Sanofi can expand filing for registration of its off-patent

medicines. Sanofi reports that cefotaxime, ceftriaxone andantibiotics and antifungals listed on the 2021 WHO EML,

colistin – all listed on the 2023 WHO Model List of Essential

such as colistin and fosfomycin, to more countries, including

Medicines (EML) – are no longer part of the company’s

low-income countries, with a high burden of disease.

portfolio.
To increase the availability of its products in LMICs,
Sanofi launched its non-profit Global Health Unit in 2021.
This initiative supplies 30 of its most essential medicines,
including metronidazole (Access antibiotic listed on WHO
EML 2023) and rifampicin (Watch antibiotic listed on WHO
EML 2023), to 40 LMICs. Furthermore, the Impact® brand
was launched in 2022 to provide standard care medicines
on a non-profit basis to 40 LMICs.

Publicly share raw data from surveillance programme.

Sanofi reported it is no longer partnering with the

Sanofi supports a national programme focused on S. pneu-

Observatoires Régionaux du Pneumocoque (ORP) pro-moniae, the Observatoires Régionaux du Pneumocoquegramme in France since the contract has expired.

(ORP) programme, managed by the National ReferenceCentre for Pneumococci (NRCP). Either Sanofi or the
NRCP can publicly share raw data from this surveillance
programme.

23

Antimicrobial Resistance Benchmark 2021

SNF

Overall Performance
2020

2021

42% 60%▲Access to Medicine Foundation

Sanofi
Large R&D-based pharmaceutical company
Stock exchange: EPA • Ticker: SAN • HQ: Paris, France • Employees: 99,412

SNF
PERFORMANCE
Sanofi performs average overall in its evaluated Research Areas

Performance in the Benchmark

0%compared to the other large research-based pharmaceutical companies
in scope.
R&D: Sanofi performs less well in the R&D Research Area. Its six-projectpipeline has three vaccines and three medicines. No project targets
critical and/or urgent pathogens. Sanofi has four projects in late-stage
development for which it reports having access plans.
Responsible Manufacturing: Performs well. Reports environmental risk-

Appropriate Access: Performs strongly. Files its on-and off-patent

Stewardship: Middle-performing. It does not promote antibacterial and/or antifungal medicines to healthcare professionals outside France.
It supports a surveillance programme in France of which aggregatedresults are publicly shared. It reports comprehensive conflict of interest
mitigation for its educational programme. It does not adapt brochures or

50%

100%

Points33%

R&D

10/ 3073%

Manufacturing

11/ 1584%

Access21/ 2560%

Stewardship0%

12/ 2050%

100%

How Sanofi was evaluatedproducts for registration in access countries. Reports several strategies
to expand access and ensure continuous supply of its relevant products.

54/ 90

Performance by Research Area

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

Points60%

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

●

●

●

●

●

●

●

●

packaging for patients.
● ● ● Scored●

Not scored

OPPORTUNITIES FOR SANOFICHANGES SINCE 2020

Expand breadth of R&D pipeline into more pathogens. Sanofi has antibacterial vaccines and med-

• Since 2020, Sanofi reports requesting its sup-icines in late-stage clinical development that target, e.g., S. pneumonia and M. tuberculosis. Sanofi

pliers to conduct risk assessments according

can expand the focus of its pipeline to target resistant pathogens for which R&D is limited, such as

to the guidelines of the AMR Industry AllianceCampylobacter spp. and H. pylori. It can do so by investing in in-house R&D, through acquisition or

including quantification of discharge levels

collaboration with other companies, or by joining existing public private partnerships.
Expand and tailor access and stewardship plans for late-stage R&D projects. Sanofi has both vac-against limits.
• In November 2019, Sanofi and Cyclamedcines and medicines in late-stage clinical development. It can improve access to these new prod-

launched the AnTRIbiotics campaign, whichucts, by developing plans for registration, affordability and sustainable supply. For example, for theirencourages the general public to bring expired

phase II vaccine, Skypac, Sanofi can develop equitable pricing plans that consider ability-to-pay andor unused antibiotics back to the pharmacy.

apply supply chain best practices including buffer and safety stocks and shortage mitigation strategies. In addition, Sanofi can expand its stewardship plans for its medicine R&D projects by getting
involved in comprehensive surveillance activities resistance trends information to their products aswell as other medicines often given alongside them in the long multidrug treatments required forthis disease, and to do it in relevant geographical regions where limited evidence is available.
Ensure compliance with antibacterial discharge limits at suppliers’ sites by tracking and publicly
disclosing progress and results specific to antibacterials for all sites. Sanofi can quantify discharge
levels at all suppliers’ sites and track compliance with set limits, as it does at own sites, and publicly
disclose the results. To provide clear evidence of its progress it can publicly report compliance at allsites. 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 locationsof its suppliers and waste-treatment plants for increased transparency.
Expand registration of antibacterial and antifungal medicines. Sanofi can expand filing for registration of its off-patent antibiotics and antifungals listed on the 2021 WHO EML, such as colistin
and fosfomycin, to more countries, including low-income countries, with a high burden of disease.
Publicly share raw data from surveillance programme. Sanofi supports a national programme
focused on S. pneumoniae, the Observatoires Régionaux du Pneumocoque (ORP) programme,
managed by the National Reference Centre for Pneumococci (NRCP). Either Sanofi or the NRCP
can publicly share raw data from this surveillance programme.

26

Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONS

SNFNet sales by business segment

Therapeutic areas: Cardiovascular diseases, Diabetes, Infectious diseases,

2019

Inflammatory & immune diseases, Oncology, Rare Diseases & Rare Blood

2020

disorders, Neurology.

0Business segments: Pharmaceuticals, Vaccines, Consumer healthcare
Product categories: Consumer health products, Generic medicines,
Innovative medicines, Vaccines
M&A since 2020: None in the antibacterial and/or antifungal sectors

10,000

Pharmaceuticals

25,7005,731 4,695

25,674

5,973 4,394

20,000

Vaccines

30,00040,00050,000mn EUR

40,00050,000mn EUR

Consumer Healthcare

SNF
Net sales by region
201912,756

9,082

14,2882020

13,465

9,151

13,425

10,00020,0000
United States

Europe30,000Rest of world

PIPELINE for pathogens in scope

PORTFOLIO for pathogens in scope

Pipeline size: 6 projects targeting pathogens in scope* (3 antibacterialMid-sized portfolio: At least 47 products: 33 antibacterial medicines; 11

medicines; 3 antibacterial vaccines).

antibacterial vaccines; 3 antifungal medicines

Development stages: 4 clinical projects, including the Phase II pneumococ-

On-patent vaccines: 3 (Hexaxim®, Menactra®, Shan5™)

cal conjugate vaccine (Skypac) candidate; and Shan6, a Phase III hexavalent

Off-patent/generic medicines: 10 of 44 were selected for analysis* (amox-

vaccine targeting among others H. influenzae and B. pertussis, for which

icillin [A], cefotaxime [W], ceftriaxone [W], clotrimazole [F], colistin [R],Sanofi has already obtained marketing authorization.

Fosfomycin [R], isoniazid [T], metronidazole [A], nystatin [F], rifampicin

Novelty: 0 novel clinical-stage medicine projects.

[T])‘Critical’ and/or ‘urgent’ pathogens: 0 projects targeting ‘critical’ and/or

AWaRe medicines**: 7 Access group; 14 Watch group; 2 Reserve group‘urgent’ pathogens.

Anti-TB medicines**: 7Regulatory approvals: 1 approval. In May 2021 the Indian regulatory authorities approved Shan6®, a paediatric hexavalent vaccine targeting H. influen-

SNF
Pipeline for priority pathogens

zae and B. pertussis.

3

3

0

10

20

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

SNF
Products on the market
11
0

33 3
20

40

60

● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

PERFORMANCE BY RESEARCH AREAA

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

A.1

Investments in R&D

A.2.1 Small pipeline

for antituberculosis medicines. A new water

Sanofi reports to the Benchmark the amountThe company reports six projects targeting

dispersible formulation of rifapentine/isonia-

invested during 2019 and 2020 in R&D for anti-

pathogens in scope: three medicines and three

zid for improved dosing in latent tuberculosis inbacterial and antifungal medicines and/or vac-vaccines, all targeting bacterial pathogens. Out

children is in Phase II. In Phase III, rifapentine iscines for pathogens in scope. Specific invest-of the six projects, three are in clinical develop-

included in a trial aiming at optimising the treat-ment figures were provided under confiden-

ment and one received marketing approval.

ment of latent and active tuberculosis with atiality. As a proportion of its revenues, Sanofi

shorter and simpler dosing regimen.

reports lower R&D investments than other

A.2.2 No clinical-stage novel projects

companies assessed in this indicator. In abso-

Sanofi’s clinical-stage medicine pipeline con-A.2.3 Three vaccine candidates

lute terms, however, the amount it invests is thesists of two adaptive projects developing for-

Sanofi reports three vaccine projects in its pipe-

second largest.

mulations and optimising treatment regimens

line. It includes one innovative candidate in

Pipeline targeting priority pathogens: 6*** As at 24 September 2021
Discovery

Pre-clinical

Phase I

Phase II

Phase III

Approval♦ S. pneumonia (conjugate) vaccine (Skypac)

Rifapentine - New regimen: shorter treatment[M. tuberculosis]♦ Pediatric hexavalentvaccine DTP-HepB-Polio-Hib (Shan6®) [H.
influenzae, B. pertussis] [Indian regulatory
authorities/May-21]

Rifapentine/isoniazid additional formulation:
fixed-dose water-dispersible tablet for paediatric patients [M. tuberculosis]♦ Vaccine
DTP = Diphtheria, tetanus and pertussis
HepB = Hepatitis B
Hib = Haemophilus influenzae type B*** Includes 2 projects not shown in the figure: 1 project intechnical lifecycle and 1 project in Phase IV.

* 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.

27

Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

Phase II of clinical development targeting S.

by WHO’s list of priority pathogens and/or char-tries† for three out of its four late-stage pro-pneumoniae (Skypac), and an adaptive vaccine

acterised as ‘urgent’ threats by the US Centersjects. Sanofi plans to apply for WHO prequalifi-

candidate targeting H. influenzae and B. pertus-

for Disease Control and Prevention (CDC).

cation for both of its vaccine projects (paediatricsis: Shan6®.

DTP-HepB-Polio-Hib hexavalent vaccine Shan6®,
A.3

Access plans for late-stage projects

and pneumococcal conjugate vaccine Skypac) to

Sanofi has four projects in late-stage devel-

ensure access in GAVI-eligible countries. Sanofi

opment: two tuberculosis medicines and two

does not report stewardship activities for its

Sanofi does not have any candidates in its R&D

vaccines.

late-stage antituberculosis medicine projects.

pipeline targeting pathogens defined as ‘critical’

Sanofi has ongoing clinical trials in access coun-

A.2.4 No candidates targeting critical and/or
urgent prioritiesB

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

B.1

Environmental risk-management for own

ments it makes of external private waste-treat-

terial discharge from its own or suppliers’ sites

sites and suppliers; tracks compliancement plants. It does report auditing these plantsthat manufacture antibacterials.

with limits at own sites

which includes checking the suitability of tech-

Sanofi reports a strategy to minimise the envi-

nologies used for processing waste. It alsoronmental impact of wastewaters and solid

reports employing conservative measures for

waste from antibacterial manufacturing at

effluents sent to external private and public

its sites, including audits every three years. It

wastewater plants.

reports setting discharge limits in the receiv-

B.3

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

Sanofi 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

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

environmental risk management and

GMP standards. This includes periodic risk-

as recommended by the AMR Industry Alliance.

commitment to setting limits

based audits and tracking of corrective and pre-ing environment for all antibacterials manufac-

B.2

Discharge levels are quantified at all sites using

Sanofi publishes some components of its envi-

ventive actions. Sanofi also requires its suppli-a mass balance approach, verified by chemicalronmental risk-management strategy. It is a

ers to audit their own suppliers. The Benchmark

analysis if applicable. It reports that compliancemember of the AMR Industry Alliance, whichfound no requests for official corrective actionof own sites with discharge limits is tracked.

publishes a list of recommended antibacte-from the FDA or EMA related to non-conformi-

rial discharge targets. Sanofi publishes its com-ties with cGMP at Sanofi’s own sites or any sub-bacterials APIs and drug products to follow sim-

mitment to setting these targets and assess-sidiaries that manufacture antibacterials.

ilar standards, including limits based on PNECs.

ing pharmaceutical levels in wastewaters. It pub-

It reports conducting on-site audits every 1-5

lishes information on the progress towards its

years. It also requests and reviews the discharge

risk-management strategy for pharmaceuti-

levels of its suppliers. It reports 103 of 117 sup-cals in the environment and HSE audits for pri-pliers’ sites, or 88% have been audited on vari-ority suppliers (including antibacterial suppliers).

ous HSE topics including AMR. As part of such

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

audits, suppliers are asked whether they haveronmental audits, conducted at its own sites, thequantified discharge levels but it is unclear how

sites of suppliers and/or external private andmany suppliers have done so.

public waste-treatment plants; (2) a list of these

Sanofi requires third-party suppliers of anti-

There is limited information on the require-C

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

APPROPRIATE ACCESS & STEWARDSHIP – ACCESS

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries†
Sanofi is not eligible for indicators: C.1.1 and C.2.1.

Hexaxim® is followed by the meningococcal con-prices up to 45% lower than those offered in the

For more information, see Appendix VII.

jugate vaccine Menactra®, filed in 48 countries.

private sector.

Sanofi filed all its three relevant on-patent vacC.1.2 Filed to register off-patent/generic med-cines for registration in at least one LIC.

C.2.3 Several strategies to expand access to

C.2.2 Several strategies to expand access to

Sanofi performs above average, with accessoff-patent/generic medicines for registration in

off-patent/generic medicines

strategies reported for all its three relevant

access countries. Its most widely filed relevant

Sanofi performs above average, with accesson-patent vaccines. It expands access in accessproduct is the antifungal metronidazole, filed instrategies reported for five of its 10 relevant

countries through equitable pricing, tenders

48 access countries. Five of its relevant products

off-patent/generic medicines. It expands accessand public or private partnerships. Sanofi has a

are filed in less than ten access countries. Fourto its off-patent/generic medicines in accesstiered pricing policy where price is defined byof its relevant products are filed for registration

countries through a voluntary licensing agree-

the channel of distribution and countries’ GNI

in at least one LIC.

ment, donations and tenders. In 2020, Sanofi

per capita. It partners with UNICEF to provide

coordinated the donation of 9,300 packs of

Shan5™ at a defined price. Sanofi provides evi-

metronidazole for emergency kits preparation

dence of patient reach and geographic reach forand 55,000 packs of amoxicillin in Colombia. In

some of its reported approaches. In 2020, it esti-

Sanofi performs above average, filing all its three

2020, it supplied more than 9 mn packs of iso-mates to have reached more than 5 mn people

relevant on-patent vaccines for registration inniazid and more than 1.2 mn packs of rifampicin

worldwide with Hexaxim®.

access countries. Its most widely filed relevant

containing regimens through a government

vaccine is Hexaxim®, filed in 54 access countries.

tender for tuberculosis in South Africa, withicines in 13 access countries on average
Sanofi performs above average, filing all its 10

C.1.3 Filed to register on-patent vaccines in 40
access countries on average† 102 low- and middle-income countries
where better access to medicine is mostneeded.

on-patent vaccines28

Antimicrobial Resistance Benchmark 2021

C.3

Access to Medicine Foundation

Several strategies to ensure continuous

Sanofi reports four capacity building or tech-supplynology transfer initiatives, in India, Nigeria andSanofi performs above average, with strate-

Vietnam. To mitigate against substandard andgies reported in all four areas assessed. Sanofi

falsified products, Sanofi has an anti-counterfeit-

ensures accurate demand planning and data

ing coordination network, a security department

sharing by having a monthly process for supply

to detect online illicit sales and a central labora-

planning with a 36-month time horizon. Sanofi

tory of counterfeit analysis.

has a “zero out-of-stock” objective with shortterm (up to 36 months) and long-term (36months to 5-10 years) forecasts. Sanofi mitigates against shortage risks by keeping buffer
stocks. It produces some of its APIs in-houseand ensures dual sourcing for all other APIs.

C

APPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

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

Comprehensive COI mitigation strategies

reports that it partly decouples incentives forin place for its educational programmesales agents from sales volumes of this product.

C.7

Active in one AMR surveillance programme; openly publishes aggregatedresults

Sanofi performs strongly in conflict of inter-

Sanofi engages in marketing practices thatest (COI) mitigation for the one AMR-related

aim to address the appropriate use of its anti-

Sanofi funds a national programme managed byeducational programme for HCPs assessedbacterial and/or antifungal medicines. Its mar-the National Reference Centre for Pneumococciby the Benchmark. The programme has all

keting materials reflect emerging resistance(NRCP) with the French Regional Pneumococcal

three COI mitigation strategies looked for bytrends and/or include treatment guidelines

Observatories. It is focused on S. pneumoniae

the Benchmark: (1) content is developed inde-for healthcare professionals: for pristinamycin

in France and has been running since 2000.

pendently from its marketing department; (2)(Pyostacine®).

Only the aggregated results are shared by NRCP

participants are not provided financial or material incentives (as it is a website); and (3) a policyof not using branded materials.

through peer-reviewed open-access journal
C.6

Does not report adapting brochures and/articles.

or packaging to facilitate appropriate
use by patients

C.5

Engages in sales and marketing practices

Sanofi does not report adapting brochures and/to address appropriate useor packaging to facilitate the appropriate use of

Sanofi performs above average in sales prac-

its antibacterial and/or antifungal medicines bytices. It does not deploy any sales agents to pro-patients.

mote its antibacterial and/or antifungal medicines to healthcare professionals outside ofFrance. However, for its sales in France, which
are only for pristinamycin (Pyostacine®), Sanofi

29