Developing new medicines

stimulates demand for new market

data in Africa
Renia Coghlan, TESS Development Advisors
George Jagoe, Medicines for Malaria Venture

September 28, 2015

What we’ll talk about today

1999: Why product development partnerships

(PDPs) were desperately needed for malaria

2009: Why the success of PDPs generated new

demands for market data in Africa

2015: How innovative thinking and new public

private partnerships are filling the data gap
Reminder: Malaria is an ancient plague that still
wields a deadly sword across much of the world

Source: WHO World Malaria Report 2014

Integrated approach to defeat malaria

Why MMV was created

 Drug Failure by 1999: resistance to WHO-
reccomended treatments in Africa

Burundi Kenya Rwanda Tanzania Uganda

Resistance
50%-90% 66%-87% 40% 28%-72% 10%-80%
to Chloroquine

Resistance
13%-63% 27%-40% 16%-45% 15%-34% 11%-60%
to SP

Source: "Changing national malaria treatment protocols in Africa",

MSF's Campaign for Access to Essential Medicines, 2002
Market Failure: The malaria
Market drug
Failure 2: pipeline in 2000

Source: MMV Annual Report 2000

 As of May 2015, the Global Pipeline for
Antimalarial Medicines
Research Translational Development Access
Lead Preclinical Phase I
Human Phase IIa
Patient Phase IIb/III
Patient Registration Phase
Post IV
optimisation Preclinical volunteers exploratory confirmatory Under review * approval
P218 DHFR Artemether-
Oxaboroles 1 Project BIOTEC MMV048 OZ439/PQP Tafenoquine Rectal Artesunate
Novartis (Monash/ Sanofi GSK CIPLA/Strides/TDR
Lumefantrine
Anacor UCT/TIA
LSHTM)
Novartis 1
Artemether-
DHA-Piperaquine
DHODH 3 Projects SJ733 ACT840 OZ439/FQ Arterolane/PQP Lumefantrine
UTSW/UW/Monash GSK St Jude/Eisai Sanofi
Pediatric
Actelion Ranbaxy * * Dispersible
Sigma-Tau 4 7 Novartis
2
Pyronaridine-
Open Source DDD498 KAE609 Artesunate for
Orthologue Leads CDRI 97-78 Artesunate
Drug Discovery Merck Serono Novartis injection
Sanofi Ipca Paediatric
Sydney (Dundee) 5 Guilin 3
Shin Poong
N-tert butyl Co-trimoxazole
Amino-alcohols Tetraoxanes PA92 KAF156 DHA-Piperaquine
isoquine Bactrim
Merck Serono LSTM/Liverpool (Drexel/UW/GNF) Novartis Sigma-Tau
LSTM/Liverpool/ Inst. of Trop. Med. 4
GSK
Imidazolidinedion- Pf NMT MMV253 DSM265 Artemisinin Pyronaridine-
es Imperial College (AstraZeneca) NIH/Takeda Naphthoquine Artesunate
WRAIR London * First review or Shin Poong 5
KPC 8
Fosmidomycin approval by WHO
dUTPase GSK030 Piperaquine Artemether sub- Prequalification, or by Artesunate
Pf NDH2 regulatory bodies who
inhibitors LSTM/Liverpool
GSK Jomaa Pharma lingual spray Amodiaquine
are ICH members or
Medivir GmbH ProtoPharma Ltd 9
observers
Sanofi /DNDi 6
Diversity Oriented NPC-1161-B Methylene Blue/AQ Artesunate-
Mississippi * * approved in India
Synthesis Heidelberg but not under review Mefloquine
Broad Institute by an SRA CIPLA/DNDi

RKA182 SAR97276 Sulfadoxine

LSTM/Liverpool Sanofi Pyrimethamine +
Amodiaquine
Guilin
Included in MMV portfolio post approval Artemisone
Non MMV UHKST
1 Brand name: Coartem® . Generics by Ajanta, Cipla, Ipca, Strides
2 Brand name: Coartem® Dispersible. Generic by Ajanta
3 Brand name: Artesun® AQ13
4 Brand name: Eurartesim® Immtech
5 Brand name: Pyramax®
6 Brand names: CoarsucamTM, FDC generics by Ajanta, Ipca, Guilin. Co-blistered generics by Strides, Cipla
7 Brand name: SynriamTM DF02
8 Brand name: ARCO® Dilafor
9 Brand name: ArTiMistTM
Integrated approach to defeat malaria

But what if these WHO approved drugs don’t get

where they need to be?

Or we can’t see how much impact they are making

in the market?
 Markets are
Integrated awashtoindefeat
approach bad ormalaria
sub-standard drugs…

Uganda

12%

17%

71%

Sources: ACT Watch Uganda

WHO Survey of Quality of Selected Antimalarial Medicines… (2011)
But the futureapproach
Integrated has never to
looked brighter
defeat for quality medicines to
malaria
improve health and well-being in Africa…

12%

17%
So the hungerapproach
Integrated for markettodata has never
defeat been greater – and the
malaria
convergence of interests is real….

Pharmaceutical National Disease Mgmt

Companies Programs

Policy Change to
new regimens
Quality
Data
re: drug flows
In Africa

National Drug
International Donors /
Regulatory Authorities 12%
Development Agencies
17%
Drug development drove the need for better market data

• MMV in 2007 : 4 products going into Ph III clinical trials

=> +- 3 years before registration, start planning uptake

• What kinds of market data were available?

• WHO annual epi data, but didn’t have much on market structure
• DHS data provide some info on source of access & product
• WHO / HAI surveys, then adapted by MMV for malaria-specific
• ACT Watch started in 2009

• BUT: there was no complete overview of the market

• for example, cannibalisation vs substitution of older classes?
• what was really the size of the private sector?
• what WAS the private sector – two ‘private sectors’?
The need for better data affects all areas of healthcare in Africa

“Accurate health statistics are the foundation of a good

health system. When we know what makes people ill and
why they die, we know where to put resources.”

Dr Marie-Paule Kieny
Assistant Director-General for Health Systems and Innovation, WHO

WHO press release

A commitment to improve global heath information, 6th May 2015

If we know more about the medicines gaps and the types

of medicines used, we know where to put resources.
Market data are relevant for both health and industry policy

Understand extent and speed of

Policy refinement impact of policy change

Monitor any potential gap between

Access to medicines
supply and medical need / epi data
Monitor supply chain or medicines
Patient safety linked to relatively higher risks
Monitor interaction between public and
Supply security private sector supply of key medicines

Understand drivers of expenditure,

Budgeting
at both top line and detailed level
Increase certainty to decrease
Raising capital investment costs & risks
 A collaboration to understand national pharmaceutical markets

• Partners:
= National Authority: national ownership and access to data
+ MMV: relationships in SSA and public health focus
+ IMS : pharma data management and interpretation
+TESS : use of data to support public health & investment decisions

• We developed a new methodology to measure markets

 data on all pharmaceuticals (not just malaria)
 covering entire market (public, private, NGO, donations etc)
 trend data over time
 ‘real time’ data, updated on a monthly or quarterly basis
Using market data for health policy – malaria treatment in Zambia

• Zambia population 2012: 14,3 million

• Malaria cases (annual, 2104 WHO World Malaria Report)

2009 2010 2011 2012 2013

Uncomplicated 2 976 395 4 229 839 4 607 908 4 695 400 5 465 122
Severe 191 559 161 385 163 144

• Malaria transmission varies across the country

• generally high transmission in rural areas

Treatment Policy (to Feb 2014, Malaria Treatment Guidelines, MoH)

• uncomplicated malaria : Artemether-Lumefantrine (AL)
• severe malaria : Quinine (Injectable Artsunate since 2014)
• IPT in preganancy : Sulfadoxine-Pyrimethamine

• Confirmatory testing should precede treatment

The Zambian market from a commercial perspective

• 4.5 – 5.5 million cases / year = a market….?

From 2009 – 2014, malaria products included:

• 54 identified importers
• 22 different molecule combinations
• 230 different presentations, strengths etc

• mainly treatment (i.e. not tourism dependent)

• 19 products mainly used for treatment
• 3 products mainly used for prophylaxis
• Where do children get treatment from? 80% Gvt

Source: Malaria Indicator Survey 2010, NMCC/MoH

The relationship between government policy and market share

• Public sector drives the malaria market in Zambia

Antimalarials Market Zambia, Value USD
16000'000
14000'000
Public sector (MSL)
12000'000
10000'000 "Private" sector (PRA)
8000'000
14.7m
6000'000 12.4m
4000'000
2000'000 5.1m
-
1.7m
2011 2012 2013 2014
Antimlarials market in Zambia - imports by Sector, value USD,

• Private sector represented

• 10% of value in 2012 2% of value in 2014
Local Manufacturing in Africa

There is increasing interest and political commitment to

developing a pharmaceutical manufacturing base in Africa

• AUC Pharmaceutical Manufacturing Plan for Africa

• East African Community Regional Pharmaceutical Manufacturing

Plan of Action (2012 – 2016)

• National strategies for example Ethiopia, Ghana, Uganda

• WHO Global Strategy and Plan of Action for Public Health,

Innovation and Intellectual Property
 Monitor Policy
Can such market Compliance
data contribute (1b) decisions?
to industry investment

Antimalarials market is driven by AL: volume & value

% Total %Total % Total % Total % Total
Molecule 2009 2010 2011 2012 2013

AL 74.9% 79.8% 78.1% 90.6% 84.6%

SP 8.4% 17.9% 14.1% 5.1% 4.8%

QUININE 15.1% 1.9% 7.6% 4.5% 10.5%

% Total
Market* 98.4% 99.6% 99.8% 99.8% 99.9%
Total Imports by Product, Standard Units
* Difference is made up of 15 products, almost all imported by the private sector
There is a large and consistent public sector market….BUT

• The public sector market for antimalarials is driven by 2

major donors: the Global Fund and PMI

• Those donors have strict quality and procurement criteria

• What about future epidemiological trends: WHO notes a

sharp fall in malaria cases in the 2014 WMR

• Cost / benefit analysis: investment cost vs market growth

A cautionary note – building a database isn’t as easy as it sounds

But it’s worth it!

Rome was definitely not built in one day. Lessons learnt:

• The system delivers a high quality, trend data feed

• Each country, environment and dynamic is different…

• ….Therefore, each database is custom built

• Political, financial and policy support are essential

• The uses of such data are multi-fold, but require

engagement from those who will be the end ‘consumers’

• It’s not a « one day » build: it takes time and technical

expertise to get the system right. And it can be done.
 MMV is grateful for the support of the following donors

We wish to thank the other partners in this collaboration:

IMS Health, the Zambia Medicines Regulatory Authority and
the National Drug Authority of Uganda
For further information, please feel free to contact us

Renia Coghlan George Jagoe

TESS Development Advisors MMV

renia@tessadvisors.org jagoeg@mmv.org
+41 78 749 2120 +41 79 442 8198