MMV’s Access & Product Management Strategy

Defeating Malaria Together

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

to reduce the burden of malaria in disease-endemic countries by

of new, effective and affordable antimalarial drugs. DISCOVERING, DEVELOPING FACILITATING DELIVERY & ANTIMALARIAL DRUGS Drugs only become medicines once administered to patients.

OUR MISSION

But the journey from molecule to medicine is not a seamless one.

But the journey from molecule to medicine is not a seamless one. There are many gaps in the road to patient impact.

PRODUCT DEVELOPMENT

REGULATORY APPROVAL

PRODUCT READINESS

POLICY & FINANCING

DISTRIBUTION & DELIVERY

The road to patient impact

PATIENT UPTAKE

PRODUCT DEVELOPMENT

REGULATORY APPROVAL

PRODUCT READINESS

POLICY & FINANCING


PATIENT UPTAKE

Access and Product Management fills the gaps throughout the entire product lifecycle.

REGULATORY APPROVAL

PRODUCT READINESS

POLICY & FINANCING

PRODUCT DEVELOPMENT


PATIENT UPTAKE

SUPPORT INTRODUCTION Access works closely with its pharma partners and country stakeholders to minimize time-to-market for new products and to ensure acceptability of products for maximum patient impact after launch.

SUPPORT

1

THE ACCESS

GAP

Injectable Artesunate, a newly WHO-recommended treatment for severe malaria was moving slowly in terms of introduction, acceptance, and widescale use in African countries two years after WHO prequalification and guideline change.

Slow uptake was costing lives.

MSF estimated that approximately 200 000 additional lives could be saved each year if countries switched from quinine to Injectable Artesunate.

CASE STUDY

INJECTABLE ARTESUNATE

CLOSING THE

ACCESS GAP

APM began a systematic analysis of the barriers to uptake and co-hosted a severe malaria stakeholders meeting in late 2011.

Access Gaps policy change | training | financing | mono-supplier concerns

APM’s response 1 Develop policy briefs and training materials (video, print). 2 Support revision of WHO’s severe malaria guidelines. 3 Spearhead accelerated adoption in Nigeria and DRC. 4 Create a multi-partner consortium to tap new monies and support broad rollout.

MMV and its partners CHAI and Malaria Consortium secured a $34 million, 3-year grant from UNITAID that is:

1 Supporting the direct procurement and scale-up of Inj AS in six high-burden African countries (with 4.7 million vials distributed in the first year)

2 Negotiating the entrance of a second manufacturer of Inj AS

3 Introducing first-time WHO-prequalified artesunate suppositories for the pre-referral treatment of severe malaria

Global use in 2014 of Injectable Artesunate (WHO-prequalified)

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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.)

Severe Malaria: Recapping the Partners and their roles…

PRODUCT DEVELOPMENT

REGULATORY APPROVAL

PRODUCT READINESS

POLICY & FINANCING


PATIENT UPTAKE

Treatments for Uncomplicated Malaria

Eurartesim Sigma-Tau (with marketing support from Pierre Fabre)

Product category

• Artemisinin Combination Therapy (ACT) • Dihydroartemisinin + piperaquine

Therapeutic indication

• Treatment of uncomplicated P. falciparum malaria in adults, children and infants >5kg

Dosing • Once daily for 3 days

Efficacy • 28 day PCR-corrected ACPR 94.7% - 99.9% • 42 day PCR-corrected ACPR 91.5% - 99.3%

Key features • Once daily • Good post-treatment protection

Challenges • Communicating new evidence about demonstrated safety (e.g. Cochrane 2014)

Status

• First stringent approval EMA 2011. WHO prequalified in 2015

• Approvals in Asia (Cambodia, India), and Africa (Burkina Faso, Ghana, Mozambique, Nigeria, Tanzania, Zambia*)

• Submitted for WHO prequalification in 2012 • Ongoing regulatory review in 2 African and 7

Asian countries

Next milestone

• Evaluation of use in pregnancy (IPTp alternative) and MDA in dual infection settings

• Evaluation as MDA tool in Southern Africa

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Eurartesim was first introduced in Cambodia in 2012, as part of the

country’s participation in the Global Fund-based Affordable Medicines Facility for Malaria.

Pyramax Shin Poong, University of Iowa

Product category

• 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


Efficacy • 28 day PCR-corrected ACPR > 98% • 42 day PCR-corrected ACPR 90% - 95%

Key feature • 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

Challenges • Single lifetime dosage • Pediatric formulation still in regulatory review • Geographical restrictions

Status • Approved 2012 by EMA (article 58) • WHO pre-qualification cross-reference (2012) • Approved in Asia (South Korea, Vietnam, Cambodia)

and Africa (Burkina Faso, Côte d’Ivoire, Chad)

Next milestone

• EMA decision on repeat-dose safety (2Q 2015) • EMA D120 feedback on pediatric granules

submission (Q1 2015)

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Pyramax has been evaluated in Cambodia as part of its Phase 2 and Phase 3 program

(between 2005 and 2008).

It is currently the focus of an efficacy study in Western Cambodia, an area of

artemisinin-resistant malaria.

Coartem Dispersible Novartis

Product category

• 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

Efficacy • 28 day cure rate (PCR-corrected) 94% - 98% • 42 day cure rate (PCR-corrected) 96% - 100%

Key feature • Only pediatric ACT formulation with Stringent Regulatory Approval

Challenges • Food effect: must be given with fat • Taste masked (cherry flavor) and sweetened

Status • Approved 2008 SwissMedic; 2009 WHO-PQ • Approved in 35 endemic countries • >250 million pediatric treatments distributed

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The most widely distributed WHO-prequalified malaria medicine designed

specifically to meet the needs of children.

Over 250 million courses of medicine distributed since 2009.

ASMQ* DNDi / Cipla

Product category

• Artemisinin Combination Therapy (ACT) • Artesunate + Mefloquine (FDC)


• Treatment of adults and children >5kg with uncomplicated P. falciparum


Status • Widely used in SE Asia and Latin America • New studies demonstrating efficacy and safety

in African patients

* Incorporated into MMV portfolio in 2015 (post-launch) through collaborative transfer from DNDi.

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.

ASAQ* Sanofi / DNDi

Product category

• Artemisinin Combination Therapy (ACT) • Artesunate + Amodiaquine (FDC)


• Treatment of adults and children >5kg with uncomplicated P. falciparum


Status • Widely used in Central and West Africa. • 2016 publication of results from Phase IV active

pharmacovigilance study in Ivory Coast.

* Incorporated into MMV portfolio as part of Phase IV post-launch safety study in West Africa in collaboration with Sanofi

The second most widely used WHO-prequalified ACT, with major uptake primarily in Central and West Africa.

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

Defeating Malaria Together

PRODUCT DEVELOPMENT

REGULATORY APPROVAL

PRODUCT READINESS

POLICY & FINANCING


PATIENT UPTAKE

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

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Country prioritization criteria

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2. Inclusion in treatment guidelines – WHO and National

1. Registration in key countries

Prerequisites to accelerate tafenoquine impact in countries

4. Appropriate supply chain

5. Modified clinical practice

3. Appropriate and affordable package: G6PD test + TQ

2013 –2016

Partners

Study area

Purpose

Principal investigators: NIMR, NVBDCP / Odisha Support: MMV, WHO

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

CCMP is an operational research study under programmatic conditions

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Timelines

Odisha, India 8 blocks (control and intervention) in 4

districts with different transmission intensity Population of 900K

High endemic

API 17 Forest, hilly

Hyper endemic API 30 Tribal

Low endemic

API 2

Medium endemic

API 5

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



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ACCESS SAVES LIVES!

MMV’s Access & Product Management Strategy

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