Access to Medicine Foundation

FROM THE 2021 ANTIMICROBIAL RESISTANCE BENCHMARK RESEARCH PROGRAMME

Biotechs are saving the worldfrom superbugs.
Can they also save themselves?
JUNE 2021
Biotechs or small- and medium-sized enterprises (SMEs) aredeveloping the bulk of new antibiotics, which are urgently needed
to replace those that are losing their effectiveness due to risingrates of resistance. Yet, SMEs struggle to secure the financing
and resources needed to develop and commercialise these muchneeded medicines, and face bankruptcy as a result, leaving promising candidates stuck in development. This paper examines how
SMEs are navigating the tough conditions in the antibiotic market.
It draws on new data and discussions with CEOs, investors andexperts working on drug resistance, and builds on industry trends
identified in the Antimicrobial Resistance Benchmark.

1

2021 Antimicrobial Benchmark – SMEs and the antibiotic market

ACKNOWLE DG E M E NTS

The Access to Medicine Foundation would like to thank thefollowing people and organisations for their contributions tothis report.
FU N D E RS

UK Foreign, Commonwealth and Development Oﬃce
The Dutch Ministry of Health, Welfare and Sport
Wellcome Trust
AXA Investment Managers

R ES E ARCH TE AM

E D ITO R IAL TE AM

Fatema Rafiqi

Anna Massey

Elisabetta Cesari

Deirdre CoganAD D ITI O NAL CO NTR I B UTO RS

The Access to Medicine Foundation is grateful to the following people for their thoughtful reviews of earlier drafts of thispaper: Karen Gallant and Kevin Outterson (CARB-X); JeanPierre Paccaud (GARDP); Hatim Sati (WHO); Oliver Williams(Wellcome Trust).

ACCESS TO M E D I CI N E FO U N DATI O N

The Access to Medicine Foundation is an independent
non-profit organisation based in the Netherlands. It aims toadvance access to medicine in low- and middle-income
countries by stimulating and guiding the pharmaceuticalindustry to play a greater role in improving access.
Naritaweg 227-A
1043 CB, Amsterdam
The Netherlands
For more information about this publication, please contact
Fatema Rafiqi, Research Programme Manager
frafiqi@accesstomedicinefoundation.org+31 (0) 20 215 35 35
www.amrbenchmark.org

2

Access to Medicine Foundation

Table of contents

2

About this paper

5

Introduction
Biotechs are saving the world from superbugs.
Can they also save themselves?

6

Antibiotic R&D
SMEs are powerhouses of innovation against superbugs

8

Incentives
Why do we need to ‘to fix the market’ for antibiotics?

10

Strategic partnerships
Strategic partnerships drive new approaches: an SME
survival tactic or new opportunities for growth?

16Conclusion
SMEs are finding opportunities to survive, but there are notenough to go around.

3

2021 Antimicrobial Benchmark – SMEs and the antibiotic market

About this paper

A look at how SMEs are navigating the tough antibiotic market▶︎ Small- and medium-sized enterprises (SMEs) are developing the bulk of new antibiotics and antifungal medicines.
▶︎ Despite the urgent need for the new products SMEs are developing against
superbugs, they face funding shortfalls and risk bankruptcy, potentially leaving
new medicines stranded on the lab bench.
▶︎ The Access to Medicine Foundation examines how SMEs are navigating the toughantibiotic and antifungal market while reforms and policy solutions ramp up.
▶︎ The Foundation will use its findings to advance ongoing discussions and the policies for how best to fix the market. It aims to highlight opportunities being developed by SMEs and why new incentives for engaging in antibacterial and antifungal R&D should prioritise appropriate global access to products emerging frompipelines.
How does this relate to the Benchmark?
This paper is published as part of the 2021 Antimicrobial Resistance Benchmark
research programme. This is the first of two reports that the Benchmark will publish in 2021. The second report will use 19 metrics to rank some of the world’s largest research-based pharmaceutical companies and generic medicine manufacturers on their efforts to tackle drug resistance. SMEs play a unique role in antibacterial and antifungal research and development, leading in novel projects, and generally have few products on the market. They have limited capacity, specifically whencompared to large research-based pharmaceutical companies and are therefore
examined separately.
How was the paper developed?
The conclusions in this paper have been drawn following an analysis of data on
company partnerships and pipelines, and informed by discussions with C-level executives of SMEs, investors and experts working on drug resistance, including reviewsof earlier drafts of the paper. It was further informed by a systematic review of
information published by SMEs and their partners (between January 2021-May2021), and builds on industry trends identified in the 2018 and 2020 Antimicrobial
Resistance Benchmark reports. Data on the antibacterial pipeline is from the World
Health Organization’s comprehensive report ‘Antibacterial Agents in Clinical andPreclinical Development’, published on April 15 2021 (55 late-stage antibiotic projects); and the antifungal pipeline is from the 2020 AMR Benchmark (3 late-stage
antifungal projects). Information from these various sources was cross-checked
directly with companies and their partners to ensure accuracy.
SCO PE O F TH E R ES E ARCH
SMEs
24 SMEs active in late-stage antibacterial and antifungal R&D withaccess and stewardship plans as
identified by WHO and the Antimicrobial Resistance Benchmark (seeAppendix I for full list). Two additional SMEs (Bugworks™ Research
Inc and Qpex Biopharma Inc.)
with early-stage antibacterial projects were also included. Fourcases are featured for the following
companies:
Bugworks™ Research Inc.
Cidara Therapeutic Inc.
Entasis Therapeutics Hldg
Qpex Biopharma Inc.

Products
55 late-stage antibacterial projects(Phase II and onward) as reportedby the WHO Antibacterial Agentsin Clinical and Preclinical Development Report.
3 late stage (Phase II and onward)
antifungal projects from the2020 Antimicrobial Resistance
Benchmark.

Expert Reviewers
Karen Gallant and Kevin Outterson(CARB-X)
Jean-Pierre Paccaud (GARDP)
Hatim Sati (WHO)Oliver Williams (Wellcome Trust)

Sources
SME’s websites, annual reports,
partner websites, as well as information submitted to the Benchmark directly by the SMEs. It also
draws on information available in
the public domain including peer-reviewed literature, clinical databases
and public health data sources.

4

Access to Medicine Foundation

Antimicrobials are at the heart of modern medicine. They enable infection pre-MJGraphics/Shutterstock

Biotechs are saving the world from superbugs.
Can they also save themselves?
S M ES AR E KE Y TO CO M BATI N G AM R

vention and control as well as safe surgery, and make new treatments possiblefor diseases such as cancer, among other benefits. Yet these life-saving medicines are losing effectiveness as microbes develop resistance. Experts warn of a

1 inim revoc

700,000 deaths from AMR

slow-burning pandemic from drug-resistant infections, which already cause an

5.7 million deaths annuallyestimated 700,000 deaths each year.
Small- and medium-sized enterprises (SMEs) drive innovation in new antimi-

antibiotics.

1,2

crobials (accounting for three quarters of late-stage antibacterials in the R&Dfrom lack of access toPF_p1_mini3

pipeline). Yet they face an uphill battle in securing the financing and resources
needed to bring even the most promising products to market. Many companies
go bankrupt before they can launch their products – and some fail even after
reaching this milestone.
There are few new antibiotics being developed, and, once approved, evenfewer that reach the people who need them. Each year globally, more than 5.7
million people die from treatable infectious diseases due to a lack of access to

75% of all projects active inlate-stage antibacterial R&D
today are developed by SMEs

1455
Late stage
projects
41

antibiotics. The majority of these deaths occur mainly in low- and middle-income countries (LMICs). 1 It is critical that companies and their partners startearly on to develop plans for ensuring the people most affected by rising rates
of drug resistance have access to life-saving medicines.
It is clear that the innovators of such drugs urgently need a stable economic
and policy environment suitable for developing and responsibly delivering new
antimicrobials. Potential solutions include cash payments to companies for successfully developing a new product in the form of a market entry reward, subscription models where governments make regular payments in return for guaranteed, on-demand supply of effective antibiotics and antifungals, and regulatory reform to harmonise effective routes to market approval.
How are SMEs surviving while waiting for market and policy reforms? This
paper finds that some SMEs, and their partners, are seizing opportunities tothink and act globally, forging new partnerships to meet the dire need for urgent
action in the countries facing the worst rates of resistance.

52021 Antimicrobial Benchmark – SMEs and the antibiotic market
T H E S TAT E O F PL AY I N A N T I B I OT I C S I N N OVAT I O N

SMEs are powerhouses of innovation against superbugs
Antibacterial and antifungal R&D is risky – even compared with other areas of phar-

SMEs are the engine of late-stage

maceutical innovation. SMEs currently shoulder most of this risk, dedicating theirantibacterial R&D with3:

limited resources to the development of innovative R&D projects. Many pharma-

75% of all late-stage

ceutical companies have exited the antibiotics field, due largely to a lack of incen-

R&D projects (41/55)

tives and adequate returns on investment. This has increased the world’s dependency on these SMEs when it comes to turning the tide of resistance.

66% of high priority projects

In antibacterial R&D, the pipeline remains alarmingly small in comparison withthe scale of the threat from antimicrobial resistance (AMR). A recent report by thefor AMR* (20/30)

World Health Organization (WHO)³ shows that SMEs account for the bulk of theclinical-stage antibacterial pipeline (75% of projects). The same report shows that73% of projects* that qualify

SMEs consistently target the pathogens that pose the greatest risk from AMR (asas novel** (11/15)

designated by WHO and/or the US Centers for Disease Control and Prevention).

75% presence of the compa-

Advance planning makes medicines accessible and protects effectivenessnies active in late-stage

Importantly, with only a limited number of antibiotics in late-stage development

R&D(currently at 55), each one must be protected from misuse and overuse from themoment of launch to ensure it keeps its effectiveness for as long as possible. With
eight times more people dying due to lack of access to medicine than from drug
resistance, ensuring global access must also be a priority. This requires productdevelopers to plan, before a product hits the market, how and where to make thisproduct accessible and how to safeguard the product’s effectiveness through goodstewardship.
Timely planning makes all the difference for getting treatment to those in need
and keeping resistance at bay. However, SMEs funnel most of their limited funds
toward the discovery and development of new products. This leaves few resources
to prepare for commercialisation and distribution activities, including the planning required for stewardship and access. Only 25% (8/32) of the late-stage antibiotic projects examined in the 2020 Antimicrobial Resistance Benchmark were supported by both stewardship and access plans.4
Is advance planning becoming a standard requirement?

Funding partners that stipulate advance

Initiatives that finance antibiotic R&D are increasingly stipulating that productstewardship and access planning***developers prepare stewardship and access plans. For example, the REPAIR Impact
Fund requires product developers to commit to developing such plans by the time

Partner

projects enter pivotal clinical trials. This is also a key milestone for the Combating

REPAIR Impact Fund

USD 165 mn

Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X); its grantees

Wellcome Trust

GBP 250 mn

are required to put plans in place within 90 days of products entering pivotal clinical

CARB-X

USD 480 mn

trials (generally Phase III trials, or equivalent for diagnostics).

AMR Action Fund

USD 1,000 mn

Total AMR funds

A wider systemic issue in antibacterial and antifungal R&D is that many active pharmaceutical companies, no matter their size, have limited to no experience in planning for stewardship and access, especially for LMICs. It is critical that companies
and their partners start early on to develop plans for ensuring global access andappropriate use to protect their effectiveness and delay resistance.
Several non-profit R&D funding partners, including CARB-X, the Wellcome Trust,and the AMR Action Fund provide grant recipients with business, scientific andtechnical support in the form of tools, resources, and expertise. Guidance is now
also available in a Stewardship and Access Plan Development Guide, developed by
CARB-X, the Wellcome Trust, and the Access to Medicine Foundation, among others. It sets out the practical and early actions that companies and partners can taketo ensure swifter access to new antibacterial products, while ensuring responsibleuse.

*Medicines and vaccines only, excluding projects that aim to develop ‘non-traditional’ products such as antibody
treatments.

**Meets the criteria defined by the WHO
to determine whether an antibacterial
medicine in the pipeline is novel.

***As of time of writing.

6

Access to Medicine Foundation
S T E WA R DS H I P & ACCE SS PL A N S

A birds-eye view of stewardship and access planningWith only a limited number of antibiotics in late-stage development, each one must

PF_p3_fig7
How widespread is stewardship and accessreach the people who face the highest rates of resistance, while being protectedfrom the moment of launch to ensure it stays effective for as long as possible. Hereplanning?

is a look at how widespread such planning is today, supported by examples.

PF_p3_fig5

Beingdevelopedby SMEs
14

PF_p3_fig7
13

14

55
Late stage
projects

41
Projects
by SMEs

41

193 trials are currently running across 47 countries.
Running clinical trials locally can lead to products that are more suitable for local populations. It helps lay
the groundwork for the medicine to be made available and accessible locally, if successful.

With bothstewardship andaccess plans

16

12With only
access plans

Licensing agreements are currently the most common accessprovisions.
Trials running

21

To ensure equitableglobal access, companies need to thinkglobally from theoutset. Planning foraccess should begin at
Phase II onwards.

● 1-3 ● 4-5 ● 6-7 ● ≥8

4

7

3

6

2

3

8

7

8

When trials are held in high disease burdencountries, the medicines can be made moresuitable for the population. Countries withhigh rates of resistance, such as South
Africa, allow for the swift recruitment of relevant patients.

6

4

7

6

5
4

9 projects targeting
multi-drug resistant(MDR) bacteria havetrials taking place inEurope. MDR bacteria
are estimated to cause
25,000 deaths yearly
and an annual loss of
EUR 1.6 bn.5

E X AM PLES O F STE WAR DS H I P AN D ACCESS PL AN N I N G PROVI S I O N S FO R CU R R E NT R& D
Zoliflodacin is a first-in-class oral antibiotic targeting Neisseria gonorrhoeae, a pathogen that is

In one year, 87 million people (aged 15-49) get

quickly becoming resistant to current treatments.⁶ It is being developed by Entasis and the GlobalPF
infected with gonorrhoea. In 2016, global preva-

Antibiotic Research and Development Partnership (GARDP), a not-for-profit R&D organisation devel-

lence was 0.9%.⁹oping new treatments for priority drug-resistant infections. In Phase III, it will be a novel* treatment for

Most cases were reported
in the WHO Africa region.6

uncomplicated gonorrhoea infections. Clinical trials are being conducted in countries where prevalence
is high, including South Africa, where 2 million gonorrhoea cases occur annually.⁷ The partnership agreement follows GARDP’s directive to develop strategies that take into account the local realities of thecountries where the product will be deployed. GARDP retains exclusive rights to market the product in
168 countries and territories, including LMICs. Entasis retains the rights for high-income markets.⁸
Sulopenem is being developed by Iterum Therapeutics with funding support from CARB-X. It is abroad-spectrum antibiotic demonstrating activity against extended-spectrum ẞ-lactamase (ESBL)producing cephalosporin-resistant Enterobacterales. It is in Phase III trials for the treatment of
uncomplicated urinary tract infections (uUTI), complicated urinary tract infections (cUTI) and com-

UTIs, one of the most common infections word-

PF wilde , are more dangerous in diabetic patients11and cancer patients.12, 13

plicated intra-abdominal infections (cIAI). Resistance to the antibiotics used to treat UTI is varied
and widespread. Sulopenem was initially developed by Pfizer; this was stopped despite encouraging
results. Iterum acquired the licence in 2015 and restarted development. It is partnering with Eversana
Life Science Services, a commercial services provider of pre-launch activities in the USA, but there is

8%

93%

currently no information on commercialisation in other countries.10 As a CARB-X awardee, they are
required to develop and publish a stewardship and access plan by the point of first market approval.
Iterum provides an Expanded Access Program for patients with cUTI caused by quinolone-resistant

The rate of resistanceto ciprofloxacin,used to treat UTIs,
varies greatly. For
Escherichia coli it
ranges from 8.4%
to 92.2%2

uropathogens.
An oral antimicrobial monoclonal antibody project targeting Campylobacter jejuni and E. coli bac-

PF_p1_mini2_svg
PFteria is being developed by Lumen Bioscience with a grant from the Bill & Melinda Gates Foundation.

Diarrhoea is the 2nd biggest cause of death in

The project aims to develop a cocktail of neutralising monoclonal antibody-like protein biologics tochildren and a leading cause of malnutrition.15

bind and neutralise the bacterial pathogens C. jejuni and enterotoxigenic E. coli. The bacteria targeted by the project are a major cause of diarrhoea cases and death of infants and children in LMICs.
Lumen Bioscience is currently recruiting patients for its Phase II trials. The target product profile isof an edible antibody that can be easily transported and stored, including to regions which lack cold
chain distribution. Lumen Bioscience states its commitment to deliver the compound to people living
in LMICs regardless of their ability to pay and is working with the Bill & Melinda Gates Foundation and

Diarrheal diseases account for
1 in 9 child deaths worldwide.16

other global health advocates to make these products available in LMICs.
*Due to scaling, countries with trials may not be visible on the map.
This figure is based on data for projects with a stewardship and/or access plan as identified by WHO (26 antibacterials projects) and the 2020 AMR Benchmark (3 antifungal projects), see Appendix I. Two additional projects were included (without a stewardship and access plan in place) on the basis that they are running in low- and middle-income country.

72021 Antimicrobial Benchmark – SMEs and the antibiotic market
I N CEN T I V E S

Why do we need to ‘to fix the market’ for antibiotics?
Most SMEs have not yet brought products to market, and new antibiotics generally
generate low revenues. As a consequence, SMEs have little room for error when it
comes to commercialisation once research grants have expired. They are expected
to navigate financial “valleys of death” – which starts when funding for early-stage
research runs out and only ends if investors or Big Pharma start to show interest.*
At minimum, this forces SMEs to pause development while they hunt for financing.
At worst, it means that promising and urgently needed candidates for new medicines, diagnostics and vaccines disappear when SMEs go bankrupt.
A promising drug is not enoughFor example, in 2021, the Swiss biotech company Juvabis was forced to reduce its
workforce to four employees due to financing constraints.17 This is despite its candidate antibiotic EBL-1003 demonstrating safety and tolerability in Phase I clinical trials and promising preclinical activity against drug-resistant pathogens, in particular Acinetobacter baumannii, a critical priority pathogen for antibacterial R&D
according to the WHO, and Mycobacterium abscessus. To get to this stage, Juvabis
had received extensive support from the European Gram-Negative Anti-Bacterial
Engine consortium (ENABLE) and the National Institutes of Health (NIH) for
pre-clinical development and completion of Phase I clinical trials.
To provide a buffer against bankruptcy – and encourage more companies tojoin the field – the economic and policy environment for antibiotic R&D must be
reformed. This means developing the right mix of incentives to support R&D, andto reward the market entry and the sustained availability of new products, throughnew financing, reimbursement and regulatory tools. Currently, the majority of R&D
incentives are ‘push’ incentives: financial and technical grants available to support
drug development. These typically support the riskier early phases of development,
which account for roughly 20% of the total costs required to bring a project to the
How are companies plugging the funding gap?
This chart totals the support that SMEs have raised via various push and pull incentives by
24 SMEs active in late-stage antibacterial and antifungal R&D.**PF

PU S H I N CEN T I V E S

R& D VA LLE Y O F D E AT H

PU LL I N CEN T I V E S

Financial and technical grants avail-

Here is where much of the

Cash payments or contracts that reward com-able to support drug development.

funding received at the earlier

panies for bringing a product to the market.

Example: CARB-X

stages of development runs out.

Example: NHS UK Subscription Reimbursement
Model

2,000,000,000
mn
USD 2,000

1,500
1,500,000,000
1,000
1,000,000,000
CO M PA N Y PA R T N E RS H I P S

500
500,000,000
0Discovery

I N V E S TO RS

PreclinicalThe discovery phase of researchis considered the most risky, withmany investigative leads leading to
failure. At this stage, SMEs are often
dependent on funding, or pushincentives, from governments andphilanthropic organisations.

Phase I

Phase IIAs a project begins to move throughthe pipeline, venture capitalists
and angel investors then selectSMEs to fund. Funders mostlybank on projects with a promising
return-on-investment.

*E.g., Pfizer recently acquired Amplyx Pharmaceuticals Inc., securing ownership of
Amplyx’s lead novel compound, Fosmanogepix (APX-001), under development for thetreatment of invasive fungal infections as well as their early-stage pipeline of potential
antiviral and antifungal therapies.

Phase III

MarketApproval

To help drive a project beyond thegap and into market, SMEs mainly
rely on partnerships with moreresourced and experienced pharmaceutical companies.

G OV E R N M E N T S A N D
FO U N DAT I O N S

Post-market
Approval

CO M M E RCI A L VA LLE Y O F D E AT H

Funding for SMEs tend to dry
out for a second time once theapproved antibiotic hits the market.
SMEs then rely on sales revenues
and on any royalties and milestones
from deals with other companies.

** These companies are developing 28 late-stage projects, and were identified by the
WHO and Antimicrobial Resistance Benchmark. Only companies with access and/or
stewardship plans in place were included, see Appendix I.

8Access to Medicine Foundation

market. Grants to cover the remaining 80% of costs are harder to come by, leaving a resource gap for the later phases of clinical development and post-market
approval commercialisation. In total, it costs an estimated one billion USD or more
to develop a new antibiotic.18
The most recent push incentive to step into this gap is the AMR Action Fund,which will support clinical-stage antibiotic research. Launched in July 2020, theFund is an industry-led collaboration with WHO, the European Investment Bankand the Wellcome Trust. It is currently ramping up with a commitment of approximately USD 1 billion with the aim of bringing 2-4 new antibiotics to market by 2030.
The AMR Action Fund will employ a set of Access & Appropriate Use Principals,
as stipulated for the funding from the Wellcome Trust, and will require awardees to develop and publish stewardship and access plans. As with all R&D initiatives, advance planning for stewardship and equitable and appropriate access to all,including those vulnerable LMIC populations, must be a standard step to market
and support.
Handful of countries test new approaches for sustaining companies
The United Kingdom, Sweden, the United States and Germany are each testing different national models that aim to reward companies for bringing products to market. They have several aims in common: to bring better outcomes for patientsby incentivising new, much-needed treatment options; to bring better value fornational health systems in terms of affordability and/or guaranteed supply; and at
the same time to offer companies guaranteed reimbursement toward the cost ofdeveloping the product. There are, as yet, no global or regional models.
The UK’s model is a unique pull incentive where sales volume is not the basis ofreimbursement. Instead, companies are paid for antibiotics based primarily on the
results of a health technology assessment, which evaluates the medicines’ overall value to the UK’s National Health Service (NHS). The Swedish Public HealthAgency is piloting an agreement with four pharmaceutical companies to test if a
new reimbursement model can ensure the availability of relevant antibiotics. Thismodel offers companies an annual revenue to guarantee supply of selected antibiotics within set time-frames. In the US, two potential reforms are working their way
through the legislative houses: the PASTEUR and the DISARM acts. If passed, theseacts would effectively establish a subscription style model by offering upfront payments in exchange for unlimited access to new antibiotics. Both the UK and the US PF How do the sales of an antibiotic compare to amodels stipulate stewardship provisions that should be met.

blockbuster medicine?20,21,22

Antibiotic

Growth will come from emerging markets
The antibiotics market is typically not deemed an attractive market for either pharmaceutical companies or their investors. Yet, there are clear opportunities toOmadacycline (Nuzyra®)
USD
Company: Paratek
461 mnapproved by FDA in
September 2018

USD
50 mn

engage with emerging markets and neighbouring LMICs, as well as advantages.
Growth (volume) in the antibiotics market in the coming years is expected to comeCancer medicine

Cemiplimab-rwlc(Libtayo®)Company: Regeneron
approved by FDA
in September 2018
New US sales
since launch(2019 and 2020)

from emerging markets, continuing a trend going back to at least 2000. In the decade to 2010, antibiotics consumption across 71 countries increased by more thana third (36%). Notably, just five countries, namely Brazil, Russia, India, China andSouth Africa, accounted for most of the jump (76%).19These countries have highdemand for both new and old antibiotics, and account for some of the highest rates PF Three countries consumed the most antibiotics
of AMR. These high rates can translate into faster enrollment of relevant patients

between 2000-2010 (unit: pills/ampules) 19

in clinical trials, which speeds development and can ensure trial results will reflect
the populations where the need is greatest. Further, engaging in emerging markets
and LMICs during development opens opportunities to partner with locally based
clinical trial organisations, research institutes and generic medicine manufacturers
with the resources, capacity, and local regulatory and legislative expertise needed
to rapidly ensure access to a new product. Plus, GARDP and WHO are spearheading the development of a new initiative called SECURE with UNICEF and CHAI, toexpand access to essential antibiotics to prepare countries for the silent pandemicof drug-resistant bacterial infections.

USA
6 billion

India
13 billion

China
10 billion

92021 Antimicrobial Benchmark – SMEs and the antibiotic market
S T R AT EG I C PA RT N ER S H I P SStrategic partnerships drive new approaches: an SME
survival tactic or new opportunities for growth?
Caught between the urgent clinical need for their R&D candidates and the lack offinancing and revenue, some SMEs are carving a new path. These companies aretrialling new approaches and forging innovative networks of partnerships that are
enabling them to survive and expand in the medium- to long-term. These networks
also put them in an improved position to enable broader access to new medicines
in low- and middle-income countries (LMICs) as candidates exit the pipeline. These
SMEs and their partners recognise the critical need to achieve swift global accessto their new innovations. Moreover, they are facilitated by national governments
including in India and China, which have invested in their domestic pharmaceuticalindustry including R&D and clinical trial organisation.
Two approaches are discussed here. Each enables SMEs to de-risk their operations, access additional sources of financing and revenue, and facilitate global
access at scale and at an affordable price through partnerships. These partnerships
can be with a range of local actors, such as local policy and decision makers, leading
hospitals, clinical trial organisations, generic medicine manufacturers and suppliersof active pharmaceutical ingredients (APIs). Via these partnerships, SMEs can work
toward global access to the new medicine in parallel for high-income countries andLMICs. These approaches offer SMEs a more secure route to reach those in LMICs,
with companies often partnering with China-based companies.

T WO APPROACH ES FO R SM Es CARVI NG A N EW PATHA PPROACH 1

A PPROACH 2

Expand own global footprint via local partner networks

Accelerate access by licensing for entry into key• Maintain R&D facilities in multiple countries

emerging markets• Build partnerships with local actors that can support clinical• Maintain own facilities in a high-income country

development and/or facilitate global access through commercialisation, manufacturing and distribution• Enter partnership with an actor that is either based in a key
emerging market, such as India or China, and/or has a foot-• Active collaboration between the partners to accelerate

print in strategic countries outside of the USA and Europe

development and to satisfy local regulatory criteria• Collaboration based on licensing agreements whereby the• Seek agreements with generic medicine manufacturers toachieve production at scale and an affordable price• One example discussed here: Bugworks

partner takes over the last stages of development and commercialisation per country or region as a means of accelerating development and ensuring broad access to medicine
beyond high-income markets.
• Three examples discussed here: Entasis, Qpex, Cidara.

10

Access to Medicine FoundationPFA PPROACH 1

Bugworks’ global approach to R&D and commercialisation

Market scope:
North America
Bugworks HQ
Bugworks R&D
Market scope:
Sub-Saharan Africa

Market scope:
SE Asia

Bugworks facilities
R&D partnership
Local development &commercial partnerships
with generics

Bugworks R&D
Bugworks’ global approach elevates
their sphere of influence and increases
the likelihood of infiltrating markets in
Africa and South East Asia.

• Bugworks headquarter: California, USA• Research & Development facilities in Australia, India andthe USA• R&D partnerships with clinical research organisations andacademic research centers in China, the EU, Japan, India, theUK and the USA.
• Development and commercial partnerships with generic
medicine manufacturers and local companies in India, South
Africa and the USA.

In India, South Africa and the USA, Bugworks seeks and maintains stra-

R&D target: multi-drug resistant gram-negative

tegic partnerships with local companies, organisations and generic med-and -positive pathogens

icine manufacturers to achieve synergies in R&D and lay the groundwork

Bugworks is developing novel* broad-spectrum

for bringing its GYROX products to the market in LMICs. This global

antibiotic treatments based on the GYROX family

approach expands possibilities for financing from different sources, butof small molecule antibacterial agents. These havealso ensures that innovation and testing can be done in multiple loca-

a new mechanism of action and low resistancetions, making it more likely that the new medicine will be suitable anddevelopment rate. There are three projects based

accessible for people in LMICs. Bugworks has raised USD 19 million to

on GYROX agents: one intravenous and two

date from sources such as CARB-X, including USD 7.5 million from aoral treatments that target multi-drug resistantglobal investment syndicate with the University of Tokyo Edge Capital,
Global Brain Corporation, and Acquipharma Holdings.23Most recently,

gram-negative and -positive bacteria, including

Bugworks received funding from the US Government’s Defense Threat

Staphylococcus aureus, Klebsiella pneumoniae,

Reduction Agency (DTRA).24

Acinetobacter baumannii, Pseudomonas

the ESKAPE pathogens (Enterococcus faecium,

aeruginosa, and Enterobacter spp.).
India and South Africa have high rates of AMR, which means a greaternumber of relevant clinical trial participants can be recruited, and clinical trials are conducted under the context where the new medicine isurgently needed, further accelerating development of effective products.
If Bugworks successfully moves its products through the entire pipeline, its multi-country approach increases the potential for accessibility incountries across South East Asia and Africa.

*Meets the criteria defined by the WHO to
determine whether an antibacterial medicine in the pipeline is novel.

11

2021 Antimicrobial Benchmark – SMEs and the antibiotic marketPF

A PPROACH 2

Entasis’ licensing agreement opens up new financial and market opportunities in Asia-Pacific

Zai HQ/R&D
Zai HQ/R&D

Entasis HQ/R&D
Market scope:
China, E Asia
Wider potential
market:Asia-Pacific

Entasis facilities
Zai Lab Ltd. facilities
Zai production facilities

Zai Lab is leading new clinical trials
and coordinating the registration and commercialisation of sulbactam/durlobactam in countries
across the Asia-Pacific.

• Entasis headquarter: Massachusetts, USA.
• Research & Development facilities in the USA (sulbactam/
durlobactam Phase III trials in 17 countries including Brazil,
China, India, Mexico, Peru, Thailand).
• R&D and commercial partner: Zai Lab (HQ and R&D facilities in China and the USA).
• Partnership: Licensing and collaboration agreement covering countries in the Asia-Pacific region.

Entasis takes an international approach to managing its antibacterial

R&D target: A. baumannii

pipeline. It is developing zoliflodacin (see p. 7) with GARDP, while sulbac-

Entasis is developing the combination of a ẞ-lactam

tam/durlobactam is covered by a partnership with Zai Lab that started inand ẞ-lactamase inhibitor: sulbactam/durlobac-

2018. Zai Lab is a commercial-stage biotechnology company with head-tam. Sulbactam is the ß-lactam antibiotic with activ-

quarters in China and in the USA. Its global R&D center is in Shanghai,

ity against A. baumannii. Durlobactam is a novel

and it has manufacturing sites in Suzhou. Zai Lab’s discovery operations

broad-spectrum IV ß-lactamase inhibitor withare spread between Shanghai, Boston and San Francisco. Entasis’ part-

broader activity against Class A, C and D ß-lactama-nership with Zai Lab is based on a licensing and collaboration agreement.

ses. The combination is developed to treat infec-

As part of this agreement, Zai Lab gains the exclusive license to develop,

tions caused by multidrug resistant A. baumannii,

register and commercialise sulbactam/durlobactam in China, Korea,

including carbapenem-resistant A.baumannii-

Vietnam, Thailand, Cambodia, Laos, Malaysia and Indonesia.

calcoaceticus complex strains. A. baumannii causes

The agreement includes a global strategic development collaboration,a range of infections and is one of the most prevalent causes of nosocomial infections,25, 26 and is esti-

wherein Zai Lab takes the operational lead to support trials and coordi-

mated to account for more than 200,000 cases

nate the registration and commercialisation of sulbactam/durlobactam

in China each year.27 With resistance on the rise,in countries across the Asia-Pacific region. The collaboration is currently

WHO and CDC have categorised it as a ‘critical’ andworking on a Phase III clinical trial in China. The trial, called ATTACK‘urgent’ priority for R&D respectively.

(Acinetobacter Treatment Trial Against Colistin), is a global, two-partPhase III registrational trial enrolling approximately 300 patients withpneumonia and bloodstream infections caused by carbapenem-resistantA. baumannii. The data readout is expected in 2021.
Through its partnership with Zai Lab, Entasis is able to share the risk ofdeveloping and commercialising sulbactam/durlobactam across the Asia
Pacific region, while securing potential future licensing revenues. In turn,this future revenue stream decreases its overall corporate risk profileand opens doors to new financing sources.

12

Access to Medicine FoundationPFA PPROACH 2

Qpex’s licence brings urgent new treatment options for carbapenem-resistant pathogens to China

Market scope:
Greater China

Qpex HQ/R&D

Brii HQ

Through its partnership with Brii, it will
be easier for Qpex
to bring other products to the region via
its global development
program.

Qpex facilities
Brii facilities
Brii production facilities• Qpex headquarter: California, USA.

R&D target: carbapenem-resistant A. baumannii,• Research & Development facilities in the USA (Phase I trials

P. aeruginosa, and Enterbacterales.

run in US and Australia).

Qpex is developing three products targeting resist-• R&D and commercial partner: Brii Bioscience (HQ and R&D

ant gram-negative pathogens including carbap-

facilities in China and the USA; market presence in China).

enem-resistant A. baumannii, P. aeruginosa, and• Partnership: a multi-product development, manufacturingEnterbacterales. Carbapenem-resistant infections

and commercialisation collaboration in China.

are associated with high morbidity and mortality

Qpex has licensed the clinical-stage company Brii Biosciences (Brii) thedue to lack of therapeutic options as high as 40%65% and 8%-52% in children.28,29 Two of these pro-rights to develop, manufacture and commercialise the three products injects are based on an ultra-broad spectrum cyclic

China. In return, Qpex receives a one-off up-front payment, with further

boronic acid ẞ-lactamase inhibitor (QPX7728).

payments dependent on the achievement of specific development, reg-

QPX7728, has demonstrated activity in combina-

ulatory and commercial milestones. Once sales of the products begin,tion with several different companion ẞ-lactam anti-

Qpex will also receive tiered royalties. Brii will share the costs of Qpex’s

biotics against carbapenem-resistant strains of A.

global development programme.

baumannii (CRAB), P. aeruginosa, and cephalosporin-and carbapenem-resistant Enterobacterales

This strategy was selected for three main reasons. Firstly, Qpex’s clin-(CRE). The combination of QPX7728 and merope-

ical products directly target the drug resistance mechanisms that arenem was found to be the most potent ß-lactam/

highly prevalent in clinical isolates of A. baumannii, P. aeruginosa, andß-lactamase inhibitor combination tested againstEnterbacterales in Greater China. Secondly, Qpex’s clinical products

all groups of CRE with multiple resistance mech-address a high unmet need in China for specific treatment options.

anisms. Both i.v. and oral forms of QPX7728 are

Thirdly, China presents a profitable market in its own right, and throughbeing developed in combination with undisclosed

its partnership with Brii, developing and gaining approval for the productß-lactam antibiotics. The third project is a next-gen-in Greater China, it will be easier for Qpex to bring its products to thateration polymyxin (QPX9003). In preclinical studies,region through its global development program. By sharing the costs and

QPX9003 has demonstrated activity against mul-

the research from the global development programme, Qpex also sharesti-drug resistant A. baumannii and P. aeruginosa andthe risks while accelerating the development and commercialisation pro-has a better safety profile compared to colistin andcess for several areas of the world.

polymyxin B.

13

2021 Antimicrobial Benchmark – SMEs and the antibiotic marketPF

A PPROACH 2

Cidara partners with global network to sustain efforts and broaden accessMarket scope:
North America

Cidara HQ/R&D

Market scope:
EuropeMarket scope:
Asia Pacfic

Market scope:
Latin America
Market scope:
Middle East
Market scope:
AfricaCidara facilities
Mundipharma facilities
Through its agreement, Cidara can leverage Mundipharma’s global presence
for market access while sustaining its
ongoing R&D efforts.

• Cidara headquarter: California, USA.
• Research & Development facilities: the USA (tworezafungin Phase III trials in 26 countries, including China,
Colombia and Thailand).
• R&D and commercial partner: Mundipharma, a global network of associated companies (decentralised structure with
operations and market presence across Africa, Asia Pacific,
Canada, Europe, Latin America and the Middle East).
• Partnership: exclusive commercialisation rights torezafungin outside the USA and Japan.

R&D target: candidemia
Cidara is developing rezafungin, an echinocandin

In 2019, Cidara granted exclusive commercialisation rights to rezafungincurrently in Phase III trials for the treatment of can-outside the US and Japan to Mundipharma, a global network of associ-didemia (blood stream infection) and invasive can-ated companies with research, development and manufacturing facilities

didiasis (infections caused by Candida spp. that canand presence across Africa, Asia Pacific, Canada, Europe, Latin America

affect the blood, heart, brain and eyes, among otherand the Middle East. In exchange, Cidara received an upfront payment

parts of the body) and for the prevention of inva-

and equity investment, as well as near-term funding to support ongo-

sive fungal disease caused by Candida, Aspergillus,

ing Phase III trials for the treatment and prevention of fungal infections.

and Pneumocystis species in the recipients of blood

For Mundipharma, this partnership enables access to a much-needed

and marrow transplantation. This new medicine isdrug for people with cancer or HIV in key markets where it has a pres-designed to provide several advantages over exist-

ence. As Mundipharma further develops and commercialises rezafungin,

ing treatments, including a simpler dosing regimen

Cidara will also receive milestone payments and royalties. Moreover,(one IV dose administered per week) and better

Mundipharma has assumed responsibility for approval submissions toefficacy against some drug-resistant Candida spe-

the regulatory authorities in its territory while Cidara focuses on prepar-

cies. Invasive candidiasis is a devastating infection

ing and gaining approval from the US Food & Drug Administration (FDA).

in immunocompromised or critically ill, hospitalised
patients, such as those with cancer with an associated mortality rate of up to 50%.30 Invasive candidiasis is also the most frequent fungal infection in
HIV positive patients.31 The incidence of candidemia
has increased five-fold in the last 10 years globally.
The increase is most evident in LMICs, where therates are 4 to 15 times higher than in high-income
countries.32

14

Access to Medicine FoundationC A S E S T U DY

China is a prominent market for antibiotic development
partnerships

China: A gateway for accessPF

to markets in Asia?

SMEs often work with partners in China when seeking antibiotic development andcommercialisation partners, as indicated by our review of partnership announcements issued by companies developing late-stage antibacterials and antifungals.
Will developments in China provide a gateway for ensuring access to successful
new medicines in low- and middle-income countries (LMICs)? There are compelling signs that China will become a global hub for the development, manufacturing and commercialisation of antibiotics and antifungals with several partners from
China partnering with SMEs from around the world in the near to medium term. If
so, what happens in these relationships and how access is brought to populations
within China will be key for achieving good stewardship and global access to theselife-saving medicines.
China is the largest producer and user of antibiotics
The business case for partnering with companies and organisations in China isstrong. China is one of the largest producer and user of antibiotics in the world.33
Per its National AMR Action Plan (2016-2020), China committed to increasing its
investments in antibiotic R&D, aiming to launch 1–2 new antibacterial agents and
5–10 new diagnostic tools.34 Developing and gaining approval for new products in
China can open opportunities to bring new antibiotics to other markets in Asia.
China ranks among the countries with the highest incidence of AMR. For example, infections of A. baumannii in China account for approximately 11% of all Gramnegative infections worldwide. The resistance of A. baumannii to the carbapenem
class of antibiotics in China has increased significantly in recent years. Estimatedat 60% in 2016, rates in some provinces are now as high as 70-80%.35 A study cited

China ranks among the countries with the highest incidence of AMR.
By 2050, antibiotic resistance could result in 1
million pre-mature deaths in China at a cost of 20
trillion USD.
10 SMEs are reaching into China markets via
licensing agreements. One SME, Aridis, established a joint venture with Shenzhen Hepalink, apharmaceutical company based in Shenzhen forthe development and commercialisation of two
projects targeting P. aeruginosa and methicillin-resistant S. aureus (MRSA).
Per its National AMR Action Plan, China is committed to increasing investments in antibiotic
R&D.
Gaining market approval in China can open
opportunities to bring new antibiotics to othermarkets in Asia.

by WHO estimated that, by 2050, antibiotic resistance could result in 1 million premature deaths annually in China at a cost of USD 20 trillion.36 As part of its National
Campaign for Rational Antibiotic Use, China will require all hospitals to educate
staff, implement antibiotic prescription guidelines, conduct prescription reviews andfeedback, and adopt a web-based prescribing system.34
This level of prioritisation, alongside rising rates of AMR, means that doctors
in China need faster, affordable access to old and new therapies. It has the public health infrastructure and advanced digital and data technologies to enable thataccess at scale.37 China employs a technology-based distribution system integrated
with a centralised system for tracking prescriptions and personal health information, which provides opportunities to ensure good stewardship. All product developers seeking to bring antibiotics to market, whether in China or elsewhere, havethe responsibility to build stewardship and access provisions into their partnershipagreements, so that the most vulnerable populations can benefit from appropriate
access to the new medicines.

15

2021 Antimicrobial Benchmark – SMEs and the antibiotic market

CONCLUSI O N

SMEs are opening gateways for new drugs to reach new markets.
With better incentives, this could lead to global access.
Each year, 5.7 million people die from treatable infectious diseases – most live in low- and middle-income
countries (LMICs) – and 700,000 people die each year from drug-resistant infections. New antibiotics andantifungals are urgently needed to replace the ones losing their effectiveness. Even though small- and medium-sized companies (SMEs) are developing the bulk of the late-stage antibacterial and antifungal pipeline,
they struggle to secure resources and face bankruptcy as a result. When SMEs fail, their pipelines are frozen,
leaving new drugs stranded on the lab bench. If the loss of such promising products continues, the pandemicof drug-resistant infections will pose a bigger global health emergency than COVID-19. This paper showsthat SMEs are finding new ways of navigating the broken antibiotic market.
People in LMICs are being

A stable economic and policy environment is urgently needed for developing and responsi-

left last in line for new

bly delivering new antimicrobials. SMEs now play a prominent role in antimicrobial R&D fol-antibiotics.

lowing the departure of many pharmaceutical companies and investors from this space. Whilethe current mix of R&D incentives is valuable, it will not be enough to prevent the slow-burning pandemic of drug-resistant infections. People living in LMICs will be left last in line for
new products unless the policy and regulatory environment is explicitly re-designed, including
through the use of market entry rewards and subscription models, to enable and incentivise
global access to antibiotics and antifungals.

All companies – large andMany companies active in antimicrobial R&D appear to be waiting for a concrete system of pull

small – are competing for a

incentives to be implemented. While waiting for incentives to ramp up, companies compete forsmall pool of R&D lifelines.

a mosaic of funding and revenue sources, such as the subscription models being piloted by the
UK and Swedish governments, and grants e.g., from the AMR Action Fund, BARDA, CARB-X
and Wellcome Trust.

Out-of-the-box thinking canSome SMEs and their partners are bringing their products into specialised situations in hospi-

pair effective new products

tals and healthcare settings, such as to support cancer treatment, or for intravenous use. SMEs

with hospital-based

thereby meet a critical need in a system that is at least somewhat prepared to pay for delivery.

opportunities

They are using partnerships in countries such as China, India and South Africa to accelerate
development and secure prospective revenue streams. They and others like them aim to survive and expand by making new medicines accessible in emerging markets and neighbouring
LMICs at the same time as in high-income markets. Most efforts center on emerging markets
and hospital settings. Community-based infections must also be prioritised in order to achieve
health for all as promised in Sustainable Development Goal 3.

China is developing into a

A review of the partnerships announced by SMEs with projects in late-stage development indi-

hub for antibacterial devel-

cates that they focus on China when seeking antibiotic development and commercialisation

opment and commerciali-

partners. This is likely due to high demand for antibiotics, the government’s prioritisation ofsationR&D and stewardship, and a mature network of partners that can share risks and offer financing and revenues. This trend raises the possibility of China being a future gateway for ensuring
equitable and responsible access to successful new antibiotics and antifungals for people living in other LMICs.

Antibiotics are not reach-

There are few new antibiotics being developed, and, even fewer that reach the people who

ing the people who need

need them once approved. Eight times as many people currently die from lack of access tothem. Advance planning

medicine than from drug-resistant infections. Further, each antibiotic must be used respon-

for access and stewardshipsibly to ensure it stays effective for as long as possible. This will only happen when SMEs andmust become standard.

their product development partners, supported by investors and donors, are able to makestewardship and access planning a standard step, from Phase II. Then equitable and appropriate access to antibiotics can become the norm, not the exception.

16

Access to Medicine Foundation

APPE N D IX I .
Breakdown of the access and stewardship plans being carried out by SMEs. This chart● Covers LMICs

shows the SMEs with a least one stewardship and/or access plan in a place for a late-stage● No information available

antibacterial and/or antifungal project as identified by the AMR Benchmark and WHO.

○ No stewardship plan

Development
Company/Developer
Project name
Phase
Allecra Therapeutics GmbH Cefepime/enmetazobactam Phase III

Access Plan Detail

Stewardship Plan Detail

Licensing Agreement (Exclusive), Shanghai Haini
Pharmaceutical Co. Ltd. (CHINA)
Expanded Access Program

Sureveillance programmes(Susceptibility Test)
Davos Declaration 2016,
Commitment●

Amplyx Pharmaceuticals Inc Fosmangofepix (antifungal)

Phase II

Aridis Pharmaceuticals Inc

AR-101 mAb (Aerumab )Phase II
(completed)Aridis Pharmaceuticals Inc

AR-301 mAb (Salvecin®)Phase III

Aridis Pharmaceuticals Inc

AR-105 (Aerucin®)Phase II

Cidara Therapeutics Inc

Rezafungin (anitfungal)

Phase III

Entasis Therapeutics
Holdings Inc

Sulbactam/durlobactam

Phase III

Entasis Therapeutics
Holdings Inc

Zoliflodacin

Phase III

ImmuniMed Inc

IM-01 (Antibody-Vaccine
Therapy)
Tonabacase (N-Rephasin®
SAL200)
Sulopenem,
Sulopenem etzadroxil/
probenecid

Phase II
Phase II

iNtRON Biotechnology Inc
Iterum Therapeutics Plc

TM

LegoChem Biosciences Inc

Delpazolid (LCB01-0371)

Lumen Bioscience Inc

LMN-101

Melinta Therapeutics Inc

Delafloxacin (Baxdela®)

Melinta Therapeutics Inc

Meropenem/vaborbactam(Vabomere®)

MicuRx Pharmaceuticals Inc Contezolid (MRX-1)(CHINA)
Nabriva Therapeutics Plc

Lefamulin (XenletaTM)

Paratek Pharmaceuticals Inc Omadacycline (Nuzyra®)
Qurient Co., Ltd

Telacebec (Q-203)

Scynexis Inc

Ibrexafungerp (antifungal)

Sequella Inc.

Sutezolid

Spero Therapuetics Inc

SPR-720

Summit Therapeutics Inc

Ridinilazole

TenNor Therapeutics Ltd
TNP-2092(CHINA)La Jolla Pharmaceutical Co Eravacycline (XeravaTM)

Licensing Agreement (Exclusive), Serum Instituteof India Ltd. (INDIA)
Licensing Agreement (Exclusive), Shenzen
Hepalink Pharmaceutical Group Co. Ltd. (CHINA)
Licensing Agreement (Exclusive), Serum Instituteof India Ltd. (INDIA)
Licensing Agreement (Exclusive), Shenzen
Hepalink Pharmaceutical Group Co. Ltd. (CHINA)
Licensing Agreement (Exclusive), Serum Instituteof India Ltd. (INDIA)
Licensing Agreement (Exclusive), Mundipharma
International Ltd. (UK)
Expanded Access Program
Licensing Agreement (Exclusive), Zai Lab Ltd(CHINA)
Equitable Pricing Strategy
Expanded Access Program (US)
Equitable Pricing Commitment (Tiered Pricing),
GARDP

●

●

●

●

○

●

Surveillance; Avoid expansion of use in unnecessary
indications●

Stewardship and Responsible
Use Commitment, GARDP;
Surveillance Studies;
Developed for treatment of
one indication, gonorrheae.

●

Humanitarian commitment to provide access indeveloping countries.

●●

Licensing Agreement, Roviant Sciences Inc(SWITZERLAND)●●(CHINA)
Working Group on New TB Drugs (Stop TB
Partership)
Commitment to provide access in developing
Phase II
countries, and Bill & Melinda Gates Foundation
Funding.
Licensing Agreement (Exclusive), Menarini Group
Marketed(Italy)Licensing Agreement, Eurofarma Laboratories Co
Ltd (BRAZIL)
Liciensing Agreement (Exclusive), Menarini Group
Marketed(Italy)Licensing Agreement (Exclusive), Hikma
Pharmaceuticals Plc
Registration Filing (CHINA)
Phase III
Working Group on New TB Drugs (Stop TB
NDA submitted in Dec 2020 Partership)(China)Marketed

Licensing Agreement (Exclusive), Sinovant
Sciences Ltd/Sumitomo Pharmaceutical Suzhou
Co Ltd (CHINA)
Named Patient Program (NPP), WEP Clinical (UK)
Licensing Agreement (Exclusive), Zai Lab Ltd
Marketed(CHINA)
Working Group on New TB Drugs (Stop TB
Phase II
Partership)Compassionate Use Program
Phase III
Licensing Agreement (Exclusive) Hansoh
NDA submitted in Oct 2020 Pharmaceutical Group Co. Ltd (CHINA)
Commercialisation Agreement(US)
US only, Amplity Health (US)The Global Alliance for TB Drug Development,
Phase IISTOP TB Partnership and WORKING GROUP on
new TB DRUGS
Licensing Agreement (Exclusive), Bill & Melinda
Phase II
Gates Medical Research InstituteLicensing Agreement (Exclusive), Eurofarma
Phase III
Laboratories Co Ltd (BRAZIL)
No information available
Phase II

Drugs (Stop TB Partership)
Yes (Bill & Melinda Gates
Foundation Requirement)

●

●

●

●

●

●

●

Working Group on New TB
Drugs (Stop TB Partership)

●

●

●

●

●

Working Group on New TB
Drugs (Stop TB Partership)●●

The Global Alliance for TB
Drug Development●

Yes (Bill & Melinda Gates
Foundation Requirement)●●●

Vedanta Biosciences Inc

VE303

Phase II

Venatorx Pharmaceuticals
Inc

Taniborbactam/Cefepime

Phase III

Wockhardt Ltd (INDIA)

Levonadifloxacin (Emrok)
Alalevonadifloxacin(Emrok-O)
Nafithromycin (WCK-4873)

Marketed

Licensing Agreement (Regional), Everest Medicine Surveillance (Global In Vitro)
Ltd (CHINA)CARB-X Graduate: CARB-X awardees are required Yes (CARB-X Requirement)
to develop a stewardship and access plan at the
point of first market approval. Bill & Melinda Gates
Foundation Funding.
Licensing Agreement (Exclusive), GARDP
Stewardship and Responsible
Licensing Agreement (Exclusive), Everest Medicine Use Commitment, GARDP
Ltd (CHINA)
Registration Filing (India)●

Phase III

Registration Filing (India)

Wockhardt Ltd (INDIA)●●CARB-X Graduate: CARB-X awardees are required Yes (CARB-X Requirement)
Phase IIIto develop a stewardship and access plan at the
NDA submitted in Nov 2020 point of first market approval.
Commercialisation Agreement, EversanaTM(US)
Licensing Agreement, HaiHe Biopharma Co. Ltd.
Working Group on New TB
Phase II

Marketed

LMICs
Reach
●

●

●

●
●
●
●

●
●
●

17

2021 Antimicrobial Benchmark – SMEs and the antibiotic market

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