Eli Lilly and : 2015 Global Health Programs Report

LILLY GLOBAL HEALTH PROGRAMS REPORT 2015

Finding New Solutions

Through Partnership

Table of Contents

03 Message from the CEO

About Lilly

05 Our approach

06 Research, Report, and Advocate

The Lilly MDR-TB Partnership

07 An unexpected journey

08 Birth and evolution of the Lilly MDR-TB Partnership

1. Partnership highlights
2. International efforts
3. TB drug discovery efforts

The Lilly MDR-TB Partnership

12 - China

15 - India

18 - Russia

21 - South Africa

The Lilly NCD Partnership

1. The rising burden of NCDs
2. Tackling NCDs through partnership
3. Partnership highlights
4. Our approach

1. Creating shared value
2. Other diabetes efforts

The Lilly NCD Partnership

29 - Brazil

33 - India

38 - Mexico

42 - South Africa

1. Lilly Corporate Responsibility
2. List of Terms
3. Our Partners
   For more information about Lilly Global Health Programs, please visit www.LillyGlobalHealth.com.

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	MESSAGE FROM THE CEO
	There are no shortages of global health challenges confronting international organizations,
	national and local governments, communities, and families. For all of our human ingenuity and
	advances-which have helped billions of people live longer, healthier, more active lives-far too
	many are left behind.
	Diseases, old and new, infectious and chronic, continue to plague the most vulnerable among us,
	taking root in impoverished villages, overcrowded settlements, remote landscapes, and anywhere
	access to quality health care is lacking. Society and governments worldwide are desperately seeking
John C. Lechleiter, Ph.D.	solutions for these challenges that threaten to drain budgets, dampen productivity, and fracture
Lilly Chairman, President,	families and communities.
and Chief Executive Officer
2015	As a global biopharmaceutical company, we have a responsibility to help expand access to our
	medicines and improve patient outcomes. But our company vision-to improve global health in the
	21st century-demands that we do even more.
	Like many other pharmaceutical companies, we have used traditional philanthropy and product
	donations to help people in immediate need. But these efforts, vital though they are, are no match
	for the scale of deeply rooted healthcare challenges that disproportionately affect low- and middle-
	income countries.
	We need new solutions. New approaches.
	We need to think bigger. And differently.
	We need collaboration on a greater scale than ever before.
	Those beliefs serve as the foundation of Lilly's Global Health Programs. Through these programs,
	we are partnering with nearly 50 leading health and governmental organizations to help tackle two
	stubborn diseases: tuberculosis (TB) and diabetes. No single organization can, on its own, solve the
	complex web of challenges underpinning these two diseases. But through strategic public/private
	partnerships-with each organization applying its unique capabilities, expertise, and assets-we can
	make far greater progress, even faster.
	Lilly Global Health Programs include our two signature corporate responsibility efforts-the Lilly
	MDR-TB Partnership and the Lilly NCD Partnership, both of which are covered in detail in this report.
	Through collaboration with partners, and the application of Lilly's unique Research, Report, and
	Advocate framework (see page 6), we are exploring sustainable new models of care that strengthen
	healthcare systems, improve outcomes, and reduce costs. In the process, we are collecting evidence-
	based data that will help governments and other key stakeholders make better informed healthcare
	decisions and replicate and scale up proven approaches.
	Ultimately, we seek to be a catalyst for ideas, solutions, action, and results.
	We are honored to work side by side with our partners, each of which offers unique insights,
	capabilities, ideas, and passion. Without them, the progress detailed in this report would not be
	possible.
	Together, we are achieving far more than any one of us could do alone, and in doing so, we are
	making life better for more people around the world.

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About Lilly

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We discover, make, and deliver life-changing medicines, improve the understanding and management of disease, and give back to the communities where we live and work. Given the complexity of today's health challenges, we also partner with leading health organizations to find new solutions that can help more people.

About the Lilly Foundation

The Eli Lilly and Company Foundation is a tax-exempt private foundation established by Lilly in 1968. The foundation awards cash grants for philanthropic initiatives aligned with Lilly's corporate responsibility priorities:

• Improving health for those in need worldwide
• Supporting communities in which we operate
• Improving public education in the United States

The Lilly Foundation funds the Lilly-MDR-TB Partnership and partners with United Way Worldwide, which makes grants on behalf of the Lilly Foundation and the Lilly MDR-TB Partnership.

©Copyright Eli Lilly and Company 2015

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Lilly Global Health Programs

Our approach

Facing a myriad of challenges such as growing populations and already-strained healthcare budgets, governments worldwide are seeking sustainable new solutions that improve health outcomes and lower costs. The challenges are exponentially more complicated in low- and middle-income countries where resources are scare, infrastructure is lacking, and healthcare systems sometimes struggle to provide even basic care.

The pharmaceutical industry-and the private sector more broadly-has an important role to play in addressing global health challenges and expanding access to quality care. For Lilly, this means going beyond just our medicines and the services we provide through our core business.

Through our Lilly Global Health Programs, we partner with governments and other leading health organizations to drive meaningful and measurable progress on global and national healthcare objectives. No product donations are involved in these partnerships. Rather, with high-level consultation and on-the- ground engagement, we are exploring new models of care and addressing critical gaps.

We do this work through our two signature global health programs-the Lilly MDR-TB Partnership, focused on multidrug- resistant TB, and the Lilly NCD Partnership, focused on non-

Through the Lilly Global Health Programs, we are:

• Partnering with leading health organizations
• Strengthening healthcare systems
• Expanding access to medicines
• Finding new solutions that can be adapted, replicated, and scaled
• Creating shared value

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communicable diseases, diabetes specifically. Both partnerships are at the heart of Lilly's corporate responsibility efforts to improve healthcare quality and outcomes for people living in low- and middle-income countries.

By using a novel approach-Research, Report, and Advocate-we are working to amplify the reach and impact of our efforts. We do this by sharing our results with the wider health community, both globally and in our focus countries, so better decisions can be made about how to invest limited resources. Ultimately, we and our partners will advocate for the replication of best practices by governments and other key stakeholders on a local, regional, national, and global scale.

No single organization can solve complex global health problems alone. We believe in achieving meaningful results through cross- sector collaboration. That's why our Lilly Global Health Programs currently involve nearly 50 well-respected global, national, and local partners-each contributing what it does best. Together, we are finding new solutions to some of today's toughest health challenges and making life better for people who live in communities where quality healthcare-and, therefore, quality of life-can be far too elusive.

Research, Report, and Advocate

Lilly Global Health Programs employ a novel approach that help make life better today for people who live in the communities where we operate our projects. At the same time, we are collecting and sharing outcomes data so that the best solutions can be replicated and scaled, reaching even more people, tomorrow.

Research

Piloting new models of healthcare in various low-income

settings and collecting evidence-based data

Report

Sharing data and lessons learned

Advocate

Using program outcomes data to advocate for broader adoption and scale-up of proven, cost-effective solutions

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An unexpected journey

Lilly has a pioneering legacy in the fight against infectious disease. In the 1940s, the company became one of the first manufacturers to mass-produce penicillin.

Throughout the 20th century, Lilly launched a number of antibiotics including vancomycin, erythromycin, and new classes of oral antibiotics that included penicillins, cephalosporins, and carbacephems.

Among Lilly's product developments were two tuberculosis antibiotics, capreomycin and cycloserine, that were among a group of second-linedrugs for TB, to be used when drug resistance causes first-linemedicines to fail.

Capreomycin and cycloserine were brought to market in 1971 and 1955, respectively. But, waning reports of TB meant that demand diminished for both medicines through the second half of the 20th century. By 1996, capreomycin and cycloserine were used to treat fewer than 1,000 TB patients per year. Some years, we had no orders for the medicines at all. In addition, to create manufacturing capacity for new medicines in our product portfolio, the company was planning to stop producing a large number of older products, including capreomycin and cycloserine.

Against this backdrop, MDR-TB was accounting for more and more of all TB cases. Unknown to Lilly, independent researchers from Partners In Health (PIH) discovered that capreomycin and cycloserine, when used in combination with other medicines, cured up to 85% of people treated in their study, at a fraction of the standard cost.

At PIH's request, Lilly increasingly supplied capreomycin and cycloserine to countries with high burdens of MDR-TB, at well- below-market prices. As demand grew in response to the growing MDR-TB crisis, Lilly doubled its manufacturing capacity for both products. But it became clear by the early 2000s that a new solution was needed to create a more sustainable, high-quality supply chain.

These circumstances presented an interesting challenge, and ultimately, a unique opportunity.

TB, often thought of as a disease of the past, continues to plague the world's most at-risk populations. It is preventable and curable, but when untreated, under-treated, or undiagnosed, it spreads rapidly.

TB is the second-leading cause of death from a single infectious agent.

Progress is being made:

• Mortality rate from TB dropped by 45% since 1990
• An estimated 37 million lives saved through effective diagnosis and treatment of TB since 2000

Drug-resistant TB is a growing crisis:

About 3.5% of all people who developed TB in 2013 had MDR-TB-which is harder to treat and has significantly poorer cure rates

480,000 new cases of MDR-TB in 2013

Almost 80% of reported MDR-TB cases occur in the European region, India and South Africa

48% global cure rate for MDR-TB-and alarmingly lower in certain hot spots

The gap between detecting and getting people started on the right treatment is growing:

• 136,000 cases detected in 2013
• 96,000 people started on treatment
• <1% of people with MDR-TB receive quality assured second-line medicines

9 Million	1.5 Million	3.3 Million	98%
Number of people	Number of people	Number of people	Percentage of deaths
developed TB in 2013	that died in 2013	with TB "missed"	that occur in countries
		by health systems,	with developing
		annually	economies

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Birth and evolution of the Lilly MDR-TB Partnership

After considering numerous options and consulting with governments, global health organizations, country-level healthcare providers, and advocacy organizations, Lilly determined that the best path forward was to give away its manufacturing technology, and technical know-how for capreomycin and cycloserine.

Beyond making medicines more readily available, it was increasingly clear that more comprehensive approaches were needed to address the complex social, economic, and medical issues associated with MDR-TB. Given our medicines, anti- infective heritage, and capabilities, we believed we could make a meaningful difference by working with other leading global health experts to find new solutions.

With the technology transfer already underway, we formally launched the Lilly MDR-TB Partnership in 2003. The partnership has grown to be our largest philanthropic effort-a $170 million commitment from 2003-2016. Through it we have worked with nearly 40 partners to elevate TB on the global stage; increase awareness, prevention, diagnosis, and treatment outcomes; ensure access to quality assured medicines; and fund early drug discovery efforts.

Using an approach we call Research, Report, and Advocate (see page 6), we are exploring and evaluating new evidence- based solutions and working with our partners and governments to identify best practices that can be adapted, replicated, and scaled to improve outcomes, reduce costs, and help turn the tide against TB in all its forms.

At a glance:

Lilly MDR-TB Technology Transfer

Over the course of a decade, Lilly partnered with seven manufacturers-four in countries with high burdens of MDR-TB-to create a reliable supply of capreomycin and cycloserine, and to improve local access to medicines. In the process, Lilly:

• Gave away its manufacturing know-how for capreomycin and cycloserine
• Used external contract manufacturers to expand supply of capreomycin during technology transfer to ensure continuity of supply chain
• Committed the time and expertise of multiple staff members over the lifetime of the project
• Offered on-site technical and quality assistance
• Funded local facility upgrades or the purchase of specialized equipment aimed at minimizing future manufacturing costs for our partners
• Worked to improve process efficiency so that partners could reinvest in local staff and facilities
• Helped partners build additional manufacturing capacity to strengthen long-term sustainability

We documented our experience with the MDR-technology transfer through a new white papertitled Seeking Solutions to a Global Health Challenge, available at: www.LillyGlobalHealth.com

"In the early 1990s, it had basically been declared that MDR-TB couldn't be treated in developing countries. Partners In Health began treating patients in the slums of Peru, and we were able to show that you can treat it. And then we realized that one of the problems was high drug prices. So we went to Eli Lilly and Company, and those guys were incredible. They actually helped us lower the price of the drugs for drug-resistant TB from about $30,000 a year to about $1,000 a year. And we actually convinced the world to lift this death sentence and treat drug-resistant TB."

Dr. Jim Yong Kim, M.D., Ph.D., President, The World Bank Group, formerly with Partners In Health

"I'm very proud of the fact that we looked beyond just the question of 'Can we supply some of these medicines at a lower cost?'-the more traditional philanthropic approach-and we thought bigger."

John C Lechleiter, Ph.D., Lilly Chairman, President and CEO

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Lilly MDR-TB Partnership Highlights

Phase I (2003-2007):

Launched in 2003 with an initial commitment of $70 million, the Lilly MDR-TB Partnership sought to reduce the burden of MDR-TB through a technology transfer and by elevating awareness of MDR-TB on the global stage.

Phase II (2007-2011):

In 2007, Lilly expanded the duration and scope for the Lilly MDR-TB Partnership by committing an additional $50 million to the collaboration to complete the technology transfer and to further strengthen awareness, prevention, and care. We also committed another $20 million for early drug discovery efforts.

Phase I & II key accomplishments

• Transferred manufacturing technology to seven companies to increase availability of MDR-TB medicines and improve standards of care
• Launched theLilly TB Drug Discovery Initiative
• Provided $20 million in funding for TB drug discovery
• Strengthened the capacity of more than 100,000 healthcare professionals to better recognize, diagnose, and treat MDR-TB, and to provide care and support to people with MDR-TB and their families
• Distributed guidelines and toolkits to more than 45,000 hospitals and clinics
• Educated, trained, and partnered with more than 350 journalists to increase and improve media coverage of TB and MDR-TB

Phase III (2012-2016):

In 2011, the Lilly Foundation provided an additional $30 million for the third phase of the partnership. During this phase, the partnership is targeting four of the highest-burdenMDR-TBcountries-China, India, Russia, and South Africa.

Two key areas of focus:

Training and capacity building for healthcare providers

Improving the supply of and access to quality-assuredsecond-line medicines

Though funding runs through 2016, some projects in target countries will conclude in 2017.

The work of the Lilly MDR-TB Partnership has been recognized at the highest levels, including international awards from the

Clinton Global Initiative, International Chamber of Commerce, and Global Business Coalition on Health.

The partnership has also been recognized at the local level, including receiving the Best Partnership Award from the China Medical Association Tuberculosis Society and recognition from the Government of the Republic of Karelia for our work with Partners In Health to improve TB care for people with HIV.

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Lilly MDR-TBPartnership-International Efforts

In addition to working in our four target countries during the third phase of the Lilly MDR-TB Partnership, we also continue to work with international organizations and partners to advance global TB efforts, including the following:

• Lilly representatives are actively engaged on several boards and committees focused on reducing the global burden of TB, including the WHO Public-Private Mix (PPM) group, the WHO Europe Regional Collaborating Committee on Tuberculosis Control and Care (RCC-TB), the Stop TB Partnership Private Sector Delegation, and the Global Fund Private Sector Delegation Advisory Group.
• We partner with the International Federation of Red Cross and Red Crescent Societies to provide on-the-ground community solutions in eight countries; the International Council of Nurses to train nurses in 10 countries; the Stop TB Partnership to help strengthen the voice of civil society in TB efforts and support the creation of a compelling, unifying brand identity for TB that will and increase awareness, understanding, and action. Was also partner with the WHO at the global level to strengthen private sector engagement in TB care and control and to disseminate best practices.
• We have played a leading role in working to ensure a reliable supply of quality-assuresecond-line medicines to treat MDR- TB.
• Lilly convened more than 40 people representing more than 20 global health, industry, and academic institutions in 2012 for the MDR-TB Innovation Summit, an unprecedented effort that helped identify several creative, sustainable solutions to supply chain challenges.

• We also served as the coordinator of the MDR-TB Second- Line Drug Access Improvement Initiative, a unique working team that included representatives from the Gates Foundation, Global Fund, UNITAID, USAID, WHO, Clinton Health Access Initiative and others. This group identified priorities for action, coordinated efforts, and responded rapidly to emerging issues.
• We funded the development of a "data dictionary" that created common standards and definitions that will improve the data flow between existing eHealth systems for MDR- TB within countries and for data consolidation globally. This will improve access to quality- assured drug supply through better drug forecasting and improved global drug supply.
• We provided a $500,000 grant in 2013 to the Global Health Committee to scale up its successful model for MDR-TB treatment and nutritional and social support into multiple regions of Ethiopia and strengthen the program in Addis Ababa and Gondar. To date, the program has resulted in more than an 80% treatment-success rate among people with MDR-TB who are HIV-negative. Lilly is also using its skills in Lean Six Sigma to lead a project for the Global Fund to improve accuracy in procuring medicines and supplies for TB, HIV, and malaria in low- and middle-income countries with high disease burden.
• Over the past several years, we've helped raise awareness of TB by supporting a global concert on World TB Day organized by our partner TOPOLO.

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