]

A message from the CEO and Chairman of the Board

Dear Stakeholders, Partners and Patients,

Throughout 2018, TB Alliance has turned to face a new frontier: we have made significant strides towards our goal of developing new tuberculosis (TB) cures that will contribute to ending TB worldwide.

With 10 million new cases per year and an estimated 1.6 million deaths, new tools to prevent, diagnose and treat all forms of this disease are urgently needed. As a nonprofit product development partnership, TB Alliance remains dedicated to developing and delivering affordable, fast-acting, safe and effective drugs that can lead to a world free from TB.

TB Alliance in 2018

On December 14, 2018, TB Alliance proudly submitted its first ever New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the review and approval of the drug pretomanid, in combination with bedaquiline and linezolid (collectively known as the BPaL regimen), for the treatment of extensively drug-resistant TB and multidrug-resistant TB that is treatment-intolerant or non-responsive. This application, which has now been accepted by the FDA for Priority Review, is a major milestone for the organization.

Such advances are made possible by strong evidence generated from extensive research conducted at all stages of the pipeline. TB Alliance conducted three concurrent pivotal Phase 3 trials in 2018, evaluating new drug regimens for safety and efficacy against all forms of the disease.

"TB Alliance remains dedicated to developing and delivering affordable, fast-acting, safe and effective drugs that can lead to a world free from TB."

Drug discovery and early clinical development are critical to sustaining the pipeline of drug candidates. Here too, we continue to see important advances, with multiple new compounds now approaching clinical development.

At the policy level, the United Nations (UN) High-Level Meeting on TB resulted in a welcome Political Declaration by heads of state, in which they have committed to close the annual $1.3 billion funding gap for TB research as well as ramping up treatment programs to find and treat all patients with TB. While significant resources and political will are still needed to ensure such ambitious promises are kept, this high-level recognition of the urgency of our mission is an encouraging step.

We have also seen welcome progress in improved TB therapy for children. Developed by TB Alliance and partners and first introduced in 2016, more than 800,000 courses of child-appropriate, fruit-flavored, dispersible medicines have been procured by 88 countries and counting.

None of our work or accomplishments would be possible without the strong support and commitment of our employees, partners, donors and especially our clinical trial participants. We cannot thank you all enough for your contribution to ending TB and improving countless lives around the world.

With another exciting year ahead, we look forward to continuing to work together toward the next frontier, building on this progress, and providing innovative treatments to all who need them.

Mel signature
Bruce signature
Mel Spigelman
President and CEO, TB Alliance
Bruce Carter
Chairman of the Board, TB Alliance
Mel Spigelman
Bruce Carter