The Real Cost
Of TB.

Annual Report 2011

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In One Day,

3,835

Lives are claimed by TB
around the world.

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That’s 1.4 million men, women and children every year. TB is an unrivaled infectious disease killer, second only to HIV. The ripple effects are staggering. Ten million children have been orphaned as a result of TB.

Tuberculosis costs the
hardest-hit countries
an estimated

Billion

Each day.

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TB most often strikes working-age adults, knocking down breadwinners and hampering national economies. Low- and middle-income countries bear the brunt of the economic burden, trapping families and communities in a cycle of poverty and disease.

And the cost of
treatment is rising

200x

To combat
drug-resistant
strains.

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Infectious multi-drug resistant strains of TB have spread to 80 countries. The cost of drugs to treat each case is 50 to 200 times higher for drug-susceptible TB, with total costs estimated at $12,462 per patient in the highest burden countries and $250,000 per patient in the United States.

New TB vaccines are the

Most cost-effective
way to stop the epidemic.

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The world can’t afford the true cost of TB. One day, new vaccines to prevent tuberculosis will save health systems billions of dollars and help eliminate TB.

TB Will be
No More.

On the Path to New TB Vaccines

TB has infected two billion people worldwide and costs the global economy hundreds of billions of dollars annually. Rising instances of TB/HIV co-infection and deadlier drug-resistant strains limit the efficacy of current control methods. The only way to eventually eliminate tuberculosis is with new vaccines.

In the past decade, the global TB vaccine field has made tremendous strides with the number of vaccines in clinical trials growing from zero to a dozen. Aeras has played an integral role in developing six of these vaccines. No one organization can do this alone; the success to date was born of the determined efforts of researchers, clinical trial volunteers, manufacturers, regulatory agencies, national and local leaders, governments, and donors, who all share our goal to end this epidemic.

Aeras is dedicated to developing new-generation tuberculosis vaccines in an affordable and sustainable manner. In support of this goal, our core objectives for 2012-2016 require global collaboration every step of the way.

1 Complete clinical trials of current candidates

We work with our clinical trial partners and funding supporters to maintain momentum in the clinic. We ensure that clinical trials are run with efficiency and excellence in order to get the best data possible.

2 Build a robust and diverse pipeline

TB is complex and may require more than one vaccine to address geographic variations in the strains, stages of the disease, and populations. We continually invest in next-generation candidates, applying lessons learned and fostering novel partnerships and approaches.

3 Refine candidate selection and advancement

In collaboration with partners, we evolve and standardize processes to focus on the most promising investigational vaccines. By using scientific approaches including challenge models, systems biology and innovative vaccine designs we accelerate advancement and cut costs.

4 Strengthen and diversify funding base

We mobilize resources across public and private entities to sustain the growing costs of TB vaccine R&D efforts as we advance toward the finish line. Only by expanding our network of support and forging new partnerships can we address the immense scientific challenges and global need.

Dear
Colleagues,

It is my great pleasure to share with you our latest annual report.

Read the
letter from the CEO

Dear Colleagues,

It is my great pleasure to share with you our latest annual report. 2011 represented a year of rapid change to strengthen Aeras as a highly efficient, best-in-class product development partnership dedicated to accelerating the advancement of new-generation TB vaccines. To achieve our goals, we have changed the way we do business across all fronts—in the way we partner, advance our pipeline, and in the way we prioritize our efforts to ensure that new TB vaccines will be available to address a disease that impacts nearly a third of the world’s population.

Pivotal to these efforts was our focus on building a world-class leadership team with significant public and private sector experience, and securing new funding that would enable us to accelerate the development of the global pipeline. Implementing these changes has enabled us to enhance collaborations with the U.S. National Institutes of Health , the China National Biotec Group , and the European and Developing Countries Clinical Trials Partnership (EDCTP) , among others. In addition, our focus on partnerships has resulted in a deepening commitment to the advancement of TB vaccine R&D among an expanding and increasingly diverse community of researchers.

A global effort: working with partners around the world to develop new vaccines

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Through our enhanced partnership with the TuBerculosis Vaccine Initiative (TBVI) we continued to refine the vaccine development process to implement a more systematic, transparent and cost-effective approach to jointly determine whether to advance each vaccine candidate to the next phase. This process enables us to evaluate results at each phase in order to focus our limited funding and trial site capacity on the most promising candidates.

Our new stage-gating criterion builds off a decade of advances in knowledge stemming from the laboratory and the field. Since 2005 alone, more than 15 vaccines have been tested in over 50 clinical trials, facilitating the development of a robust pipeline of preclinical and clinical candidates, achieving progress in developing new biomarkers, and developing capacity for vaccine production and clinical trials in the US, Europe, Africa and Asia.

Today, Aeras is supporting the development of six vaccine candidates in clinical trials, including the two most clinically advanced preventive TB vaccine candidates in the world. Three Phase IIb ‘proof-of-concept’ clinical trials of two candidates are underway, representing a critical milestone before progressing to final stages of development. In addition, two new candidates have entered the pipeline .

Current vaccine pipeline

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Looking forward, we see new challenges ahead as current candidates move into larger, more expensive clinical trials, and lessons that can only be learned in the clinic are applied to the design of next-generation vaccine candidates. Thanks to a generous grant of up to $220 million from the Bill & Melinda Gates Foundation , Aeras has secured a portion of the financial support needed to sustain the development of the global TB vaccine pipeline. These critical resources also serve as a global call to action. To get to the goal we will need support from donor governments, high disease burden countries such as South Africa, India and China as well as pharmaceutical and biologic manufacturers to advance candidates through the various development phases to ultimate licensure.

I would like to thank our donors and partners for working with us to make historic progress in the quest for new TB vaccines. While vaccines are costly and complex to develop, history has shown that they are also the most cost-effective way to save lives, prevent disease and ultimately save health systems billions of dollars.

Our journey this past year demonstrates that progress toward TB elimination requires global collaboration grounded in persistence, guided by discipline and sparked by innovation. Galvanized by our success to date, we know that only by working together will we achieve our goal to deliver new TB vaccines to the world in order to turn the tide on one of the most devastating and deadly infectious diseases.

James E. Connolly President and CEO

Meet Aeras’ Leadership and Advisors

2011
Financials

See our
2011 Financials

2011 Financials

Amounts are in US dollars. Audited annual financial statements are available upon request.

Major Supporters

Aeras can only be successful with collaboration and partnerships that help support our TB vaccine development efforts. Aeras gratefully acknowledges these important supporters along with the numerous other collaborators not listed here that help make our work possible: