2016/12/16 1 2016/12/16 1

Access without Excess: Bedaquiline Global Health Policy Forum: “Access to New Medicines”

Myriam Theeuwes, Compound Development Team Leader December 12, 2016

2016/12/16 2 2016/12/16 2

Overview

• Adult, pediatric drug

sensitive and drug resistant regimens

• WHO prequalified drugs and innovative drugs

• User-friendly diagnostic kits

• Sales to more than 133 countries

• Technical assistance to improve drug management systems

• Pioneered a standard 4-language package global package

Early Access Programs:

Russia & Lithuania

N=57

ATU France

N= 194

Compassionate Use

Global

N=554 N = 760

>800 patients

in 47 countries

Access: When Most Needed

2016/12/16 3 2016/12/16 3

Access: Where Most Needed

> 80% of the world’s MDR-TB burden has regulatory access to bedaquiline at the end of 2016.

2016/12/16 4 2016/12/16 4

Access: Janssen Approach

Established markets High burden countries Low to moderate burden countries

< 500 cases / year

500-5,000 cases / year

> 50,000 cases / year

5,000-15,000 cases / year

2016/12/16 5 2016/12/16 5

Access: Global Drug Facility

• Adult, pediatric drug

sensitive and drug resistant regimens

• WHO prequalified drugs and innovative drugs

• User-friendly diagnostic kits

A UN Operations organization within the STOP TB Department, the GDF is the largest global supplier of quality-assured anti-TB treatments

Administration and oversight of a regulatory waiver process has contributed to an significant advances in patient access to treatments

2016/12/16 6 2016/12/16 6 6

Janssen Contributions: Beyond the Pill

2016/12/16 7 2016/12/16 7

Janssen & South Africa: A New Paradigm in Collaboration

2016/12/16 8 2016/12/16 8

2016/12/16 9 2016/12/16 9

Questions? Thank you!