Role of the Private SectorRole of the Private Sector in Combating MalariagManos Perros

Musée de la Croix-Rouge, Geneva

Pfizer Global Research & Developmentg

November 12, 2009

Drug Development and the Evolving R&D E tEcosystem CROsResearch

hospitals Regulators

APPLIED

PRODUCTDEVELOPMENT

Biotech

Manufacturing

U I GFUNDING

APPLIEDRESEARCH

PRODUCTJoint ventures /PPPs

Manufacturing

HTAFUNDINGFUNDING

BASIC

PRODUCT/PPPs HTA

PhysiciansPEOPLE

IDEAS

PEOPLE

IDEAS PATIENT

BASIC SCIENCE

Universities PharmacistsIDEAS

OPEN INNOVATION

PRE‐COMPETITIVERESEARCHOPEN 

INNOVATION

PRE‐COMPETITIVERESEARCH

FOCUS

INNOVATIVE PRODUCTIDEA

Inescapable Truths of Medicines DiDiscovery

Compound Success Rates by Stage

Compound Success Rates by StageRates by Stage

4

2

0

Preclinical TestingLaboratory and

Discovery(2–8 Years)

5,000–10,000

S d250

y g5,000–10,000

Screened$$

8

6

4

Phase II100–300 Patient

Phase I 20–80 Healthy Volunteers

Laboratory and Animal Testing Screened250

Enter Preclinical

T ti

250Enter

Preclinical Testing

COST

12

10100 300 Patient Volunteers

Phase IIIUp to 5,000 Patient

VolunteersRegulatory Review & A l

Testing5Enter

Clinical Testing

COST

11Approved by RegulatorsApproved by Regulators

16

14 ApprovalAdditional Post-Marketing Testing

g

$$$$$$

Need best in class R&D to progress your idea to a

drug10-20 years from idea to bedside

fLong-term safety responsibilitiesand legal liabilities

Malaria Overview

• Over 85% of Deaths Occur in Sub SaharanOccur in Sub-Saharan Africa

• Pregnant women and Treatment/ PreventionTreatment/ Prevention

WHO Malaria Strategy – 4 Key Interventions

young children are at highest risk of death

• Renewed focus on R&D

ACTsACTs PreventionPrevention

Renewed focus on R&D with money from Gates and MMV and others

• Current and near term

Indoor SprayingIndoor Spraying IPTpIPTpMalaria

• Current and near term therapies dominated by artemisinin derivative

ITNsITNsVector ControlVector Control

combinations• Development of

resistance is a real risk

ACT: Artemisinin-based Combination TherapyIPTp: Intermittent Preventive Treatment in pregnant womenITNs: Insecticide-treated bed nets

Source: WHO Malaria Report 2008

es sta ce s a ea s

Industry DDW R&D is Increasing and I i l C ll b tiIncreasingly Collaborative

© IFPMA 2009: From IFPMA to WHO EWG 12 Jan 09.Sources: 2005 Moran et al. “A New Landscape….” 2006, 2007, 2008 IFPMA status reports

What Can Private Industry Offer?

IP and contract negotiation experience

Clinical trial partnerships Safety & risk

t

APPLIED

PRODUCTDEVELOPMENT

management

Global f t i

Medicinal chemistry and biotherapeutics

U I GFUNDING

APPLIEDRESEARCH

PRODUCTT t

manufacturingnetwork

Animal health /parasitology

FUNDINGFUNDING

BASIC

PRODUCT

Compound

Target identification

Distribution & sales

PEOPLE

IDEAS

PEOPLE

IDEAS PATIENT

BASIC SCIENCE

Scientific expertise

Compound libraries

Supply chain integrity

sales

IDEAS

OPEN INNOVATION

PRE‐COMPETITIVERESEARCHOPEN 

INNOVATION

PRE‐COMPETITIVERESEARCH

FOCUSScientific expertise integrityState-of-the art research laboratories

INNOVATIVE PRODUCTIDEA

Industry is Committing Resources Th h M lti l M h iThrough Multiple Mechanisms

© IFPMA 2009: From IFPMA to WHO EWG 12 Jan 09

Early Engagement to Expand and O ti i S iOptimise Screening

Nwaka et al. PLOS Negl Trop Dis, 2009 August; 3(8): e440.

Compound Library Screening APPLIEDRESEARCH

• Pfizer compound library made available to screen for d h i ti l i l t ti l

BASIC SCIENCEcompounds having anti-malarial potential

• Screening to be carried out at Griffith University, Australia • Pfizer and MMV to determine which compounds are suitable for

SCIENCE

pprogression into potential drugs

• Follows existing collaboration with WHO TDR:• Screen for inhibitors of 6 disease-causing organisms including P falciparumScreen for inhibitors of 6 disease-causing organisms, including P. falciparum• 10,000 compounds screened – including vet med and some previous CANs

in vitro P falciparum screen Analyse data and identify leads

Thousands of compounds

in vitro P. falciparum screen

Development of New Preventive Treatment for Pregnant Women (IPTp)

PRODUCTDEVELOPMENTTreatment for Pregnant Women (IPTp)

Azithromycin/Chloroquine (AZCQ) Fixed Dose Combination• Excellent efficacy seen in two

multi-country trials in sub-

y q ( )

Burkina Faso

Saharan Africa (≥ 98% efficacy)• Activity against falciparum

malaria and sexually transmitted

GhanaMali

malaria and sexually transmitted infections should help improve pregnancy outcomes Kenya

Senegalp g y• Plans to conduct a large multi-

country IPTp trial in countries h th t t d d f

Kenya

Uganda

Zambiawhere the current standard of care is failing

Collaboration between Pfizer MMV and London School of

Zambia

Collaboration between Pfizer, MMV, and London School of Hygiene and Tropical Medicine (LSHTM)

Distribution and SalesPRODUCT

Pfizer Africa: Regional Set-UpEurartesim® (DHA/PQP)

IRAN

SYRIA

KUWAIT

LEBANON

JORDAN

IRAQISRAEL

ALGERIA

MOROCCO TUNISIA

• Developed jointly by MMV and Sigma-Tau

• Novel fixed-dose ACT for

SAUDI ARABIA

UAE

OMAN

QATAR BAHRAIN EGYPT

SUDAN YEMEN

ALGERIA

WESTERNSAHARA

LIBYA

MAURITANIAMALI NIGER

CHAD

SENEGALERITREA

Novel fixed dose ACT for uncomplicated P. falciparum malaria

• Pfizer license and supply agreement ith Sigma Ta

NIGERIA

CAMEROON

BURKINAFASO

C.A.R.GHANA

COTE D’IVOIRE

GUINEA

THE GAMBIA

GUINEA-BISSAU

SIERRA LEONELIBERIA

BENINTOGO

EQUATORIAL GUINEAGABON

REPUBLICOF THECONGO D.R.C.

RWANDA

KENYA

UGANDA

ETHIOPIA

SOMALIADJIBOUTI

agreement with Sigma-Tau

Existing Therapies• Camoquin Plus®

CABINDA (ANGOLA)

CO GO D.R.C.

BURUNDITANZANIA

SEYCHELLES

MADAGASCARANGOLA

ZAMBIAMOZAMBIQUE

ZIBABWE

MALAWI

Legal entity

Plant

• Camoquin Plus®• Metakelfin®• Dualkin®

MAURITIUS

NAMBIABOTSWANA

SOUTHAFRICA

ZIBABWE

SWAZILAND

LESOTHO

Rep officeManufactured and distributed from Pfizer’s facilities in Dakar, Senegal

MMV Vital to Our Near- and Long-term Projects for Patientsfor Patients

New Artemisinin Combination

Intermittent Preventive

Portfolio Life Cycle

Existing Key Therapies

Therapy Treatment for Pregnant Women

Developments: Discovery of New

Medicines

for Treatment andPrevention

TodayToday 2010/20112010/2011 Medium-TermFuture

Medium-TermFuture

Long-TermFuture

Long-TermFuture