MMV s Access & Product Management Strategy

MMV s Access & Product Management Strategy Siem Reap, Cambodia 24-26 February 2015 George Jagoe, EVP, Access & Product Mgmt Defeating Malaria Together

OUR MISSION to reduce the burden of malaria in disease-endemic countries by But Drugs the DISCOVERING, journey only ANTIMALARIAL become from molecule medicines DEVELOPING DRUGS to once medicine & administered FACILITATING is not DELIVERY a seamless to patients. one. of new, effective and affordable antimalarial drugs.

The road to patient impact PRODUCT DEVELOPMENT REGULATORY APPROVAL PRODUCT READINESS POLICY & FINANCING DISTRIBUTION & DELIVERY PATIENT UPTAKE But the There journey are from many molecule gaps in the to medicine road to patient is not a impact. seamless one.

PRODUCT DEVELOPMENT REGULATORY APPROVAL PRODUCT READINESS POLICY & FINANCING DISTRIBUTION & DELIVERY PATIENT UPTAKE Access and Product Management fills the gaps throughout the entire product lifecycle.

CASE STUDY INJECTABLE ARTESUNATE 1 PRODUCT DEVELOPMENT CLOSING THE THE ACCESS ACCESS GAP GAP REGULATORY APPROVAL PRODUCT READINESS POLICY & FINANCING DISTRIBUTION & DELIVERY PATIENT UPTAKE APM began a systematic analysis of the barriers to uptake and MMV and its partners CHAI and Malaria Consortium co-hosted malaria3-year stakeholders meeting in late secureda asevere $34 million, grant from UNITAID that2011. is: Injectable Artesunate, a newly WHO-recommended treatment Access Gaps forintroduction malariathe was moving slowly in terms of introduction, 1severe Supporting procurement and scale-up of Inj AS SUPPORT policy change trainingdirect financing mono-supplier concerns acceptance, and widescale use incountries African countries years in six high-burden African (with 4.7 two million Access works closely with its pharma vials distributed in theand firstguideline year) change. response after WHO prequalification partnersapm s and country stakeholders 1 Develop policy briefs and training materials (video, print). to minimize time-to-market for new Slow uptake was costing lives. of a second manufacturer of Inj AS 2 to Negotiating the entrance products ensure acceptability ofsevere malaria guidelines. 2 and Support revision of WHO s products for maximum patient impact 3MSF Spearhead accelerated adoption in200 Nigeria and DRC. estimated that approximately 000 additional 3 Introducing first-time WHO-prequalified artesunate suppositories after launch. 4lives Create a multi-partner to tap switched new monies could be saved eachconsortium year if countries for the pre-referral treatment of severe malaria andquinine supporttobroad rollout. from Injectable Artesunate.

Global use in 2014 of Injectable Artesunate (WHO-prequalified) 11.5M vials ordered from Guilin Pharma Prequalified Inj AS has been registered in and delivered to 20 African countries and 5 Asian countries. With 25 million artesunate vials ordered since WHO prequalification, This translates to a potential 160-170K children s lives saved (vs. if treated with quinine.) 6

Severe Malaria: Recapping the Partners and their roles PRODUCT DEVELOPMENT REGULATORY APPROVAL PRODUCT READINESS POLICY & FINANCING DISTRIBUTION & DELIVERY PATIENT UPTAKE

Treatments for Uncomplicated Malaria

Eurartesim Sigma-Tau (with marketing support from Pierre Fabre) Cl Cl N Product category Therapeutic indication Artemisinin Combination Therapy (ACT) Dihydroartemisinin + piperaquine Treatment of uncomplicated P. falciparum malaria in adults, children and infants >5kg Dosing Once daily for 3 days 28 day PCR-corrected ACPR 94.7% - 99.9% Efficacy 42 day PCR-corrected ACPR 91.5% - 99.3% O O Once daily Key features O Good post-treatment protection O H H Communicating new evidence about Challenges demonstrated safety (e.g. Cochrane 2014) HO Eurartesim H was first introduced in First stringent approval EMA 2011. WHO N prequalified in 2015 Approvals in Asia (Cambodia, India), and Cambodia N in 2012, as part of the Africa (Burkina Faso, Ghana, Mozambique, Status N Nigeria, Tanzania, Zambia*) Submitted for WHO prequalification in 2012 country s participation in the Ongoing regulatory review in 2 African and 7 Asian countries N Global Fund-based Evaluation of use in pregnancy (IPTp Next Affordable N alternative) and MDA in dual infection settings milestone Evaluation as MDA tool in Southern Africa Medicines Facility for Malaria.

Pyramax Shin Poong, University of Iowa HO Cl O O O O O O H H O H Product category Therapeutic indication Artemisinin Combination Therapy (ACT) Pyronaridine + artesunate Treatment of acute, uncomplicated malaria infection caused by P. falciparum or by P. vivax in adults and children 20kg use in low transmission areas with evidence of artemisinin resistance Dosing Once daily for 3 days Efficacy Key feature 28 day PCR-corrected ACPR > 98% 42 day PCR-corrected ACPR 90% - 95% Under evaluation (WHO) as alternative ACT for use in artemisinin resistance containment. EMA label specifies use for (blood-stage) cure of both vivax and falciparum Pyramax has been evaluated in Cambodia as part of its Phase 2 and Phase 3 program Single lifetime dosage (between Challenges 2005 and Pediatric formulation 2008). still in regulatory review Geographical restrictions N Approved 2012 by EMA (article 58) WHO pre-qualification cross-reference (2012) OH Status It is currently the focus Approved of in an Asia (South efficacy Korea, Vietnam, Cambodia) and Africa (Burkina Faso, Côte d Ivoire, Chad) N HN EMA decision on repeat-dose safety (2Q 2015) study N in O Western Next Cambodia, an area of EMA D120 feedback on pediatric granules milestone submission (Q1 2015) N artemisinin-resistant malaria.

Coartem Dispersible Novartis Product category Therapeutic indication Artemisinin Combination Therapy (ACT) Artemether + lumefantrine Treatment of adults and children >5kg with uncomplicated P. falciparum infection (including mixed infection) Dosing Twice daily for 3 days O O The O most widely distributed WHOprequalified malaria medicine 28 day cure rate (PCR-corrected) 94% - 98% O Efficacy H H 42 day cure rate (PCR-corrected) 96% - 100% Only pediatric ACT designed O formulation with Stringent H Key feature Regulatory Approval specifically to meet the needs Food effect: must of be children. given with fat Challenges Taste masked (cherry flavor) and sweetened Cl HO N Cl Status distributed Cl since 2009. Approved 2008 SwissMedic; 2009 WHO-PQ Approved in 35 endemic countries >250 million pediatric treatments distributed Over 250 million courses of medicine

ASMQ* DNDi / Cipla Product category Therapeutic indication Artemisinin Combination Therapy (ACT) Artesunate + Mefloquine (FDC) Treatment of adults and children >5kg with uncomplicated P. falciparum Dosing Once daily for 3 days Status Widely used in SE Asia and Latin America New studies demonstrating efficacy and safety in African patients As a fixed-dose combination, ASMQ meets a critical role as an important ACT for use in the emergency response to drug resistance in the Greater Mekong region. * Incorporated into MMV portfolio in 2015 (post-launch) through collaborative transfer from DNDi.

ASAQ* Sanofi / DNDi Product category Therapeutic indication Artemisinin Combination Therapy (ACT) Artesunate + Amodiaquine (FDC) Treatment of adults and children >5kg with uncomplicated P. falciparum Dosing Once daily for 3 days Status Widely used in Central and West Africa. 2016 publication of results from Phase IV active pharmacovigilance study in Ivory Coast. The second most widely used WHOprequalified ACT, with major uptake primarily in Central and West Africa. * Incorporated into MMV portfolio as part of Phase IV post-launch safety study in West Africa in collaboration with Sanofi

P. Vivax Malaria (1) Preparing for the introduction of single-dose radical cure (2) Tapping a living «laboratory» to understand community delivery of radical cure

Tafenoquine: Key considerations for launch planning PRODUCT DEVELOPMENT REGULATORY APPROVAL PRODUCT READINESS POLICY & FINANCING DISTRIBUTION & DELIVERY PATIENT UPTAKE Defeating Malaria Together

Opportunity for Tafenoquine (+ G6PD test) Tafenoquine responds to a real unmet medical need Favourable policy environment: WHO new guidance on P. vivax Radical cure recommended in all transmission settings G6PD testing before radical cure with existing tests or referral to higher levels WHO ERG recommendation on specific G6PD test Push for elimination 17

18 Country prioritization criteria

Prerequisites to accelerate tafenoquine impact in countries 1. Registration in key countries 2. Inclusion in treatment guidelines WHO and National 3. Appropriate and affordable package: G6PD test + TQ 4. Appropriate supply chain 5. Modified clinical practice

CCMP is an operational research study under programmatic conditions Purpose Partners Assess the impact of universal access to diagnosis and treatment on malaria incidence in different transmission settings Better define the malaria burden and epidemiological profile in mixed infection environments Understand and address the challenges with radical cure Principal investigators: NIMR, NVBDCP / Odisha Support: MMV, WHO Study area Timelines Odisha, India 8 blocks (control and intervention) in 4 districts with different transmission intensity Population of 900K 2013 2016 21

High endemic API 17 Forest, hilly Medium endemic API 5 Low endemic API 2 Hyper endemic API 30 Tribal

Access and Product Management is mission-critical. It ensures that the right medicine in the right dose at the right time under the right conditions and at the right price gets to the right patient

Access and Product Management is mission-critical. $ It ensures that the right medicine in the right dose at the right time under the right conditions and at the right price gets to the right patient

Access and Product Management is mission-critical. ACCESS SAVES LIVES! It ensures that the right medicine in the right dose at the right time under the right conditions and at the right price gets to the right patient

ACCESS SAVES LIVES!