Viatris 2023 Sustainability Report: Continued Innovation for Infectious Disease

Increased availability of testing and antiretrovirals has led to global progress in preventing and managing infectious diseases like HIV, tuberculosis (TB), malaria and hepatitis in the last quarter of a century. However, progress is slower in some low- and middle-income countries (LMICs) where the needs are greatest, especially among more vulnerable groups like women and children. In addition, the COVID-19 pandemic, continuing emergence of antimicrobial resistance (AMR) and growing impacts from climate change have demonstrated how infectious threats can emerge and have devastating global effects.

At Viatris, we have expanded access at scale to high-quality HIV/AIDS treatment for more than a decade. Our work includes helping to prevent HIV infections, increasing diagnosis and treatment and providing healthcare solutions. We also are working on local manufacturing initiatives with partners to transfer technology to expand access where it is most needed. Over the years, we have continued to seek improvements to existing molecules to better meet patient needs, including introducing novel heat-stable generic formulations, more convenient packaging options and pediatric therapies as well as extended shelf life for certain products.

Number of countries to which we provide access to high-quality and affordable ARVs ~125

Percentage of people on treatment for HIV that use a Viatris product¹ ~32%

Viatris has worked to provide in-vitro HIV rapid diagnostic tests for self-testing in LMICs, and during 2023, we continued work to develop a dual oral pill for HIV and birth control in collaboration with the Bill and Melinda Gates Foundation and the Children’s Investment Fund Foundation. The product is expected to be filed with the WHO PQ approval by the end of 2024. All the above are important components to make progress on the collective goals of preventing HIV infections, expanding treatment and providing healthcare solutions to people living with HIV.

During 2023, we continued our partnership with the international, not-for-profit research and development organization Drugs for Neglected Diseases initiative (DNDi) for the development of flucytosine slow-release formulation, a drug used for the treatment of cryptococcal meningitis, with the intention to reduce the pill burden and increase treatment adherence.

As part of our strategy to expand access to ARV treatments, we are working with international organizations for pooled procurement, engaging in licensing agreements with originator pharmaceutical companies and the Medicines Patent Pool and participating in government tenders. We provide a single price for all applicable countries supplied via leading global procurement mechanisms, The Global Fund to Fight AIDS, TB and Malaria, and the U.S. PEPFAR Program.

Viatris has eight licensing agreements with the Medicines Patent Pool (MPP) for HIV - including PrEP - hepatitis C and COVID-19. For ARV and infectious disease products, Viatris also has license agreements with Gilead, Viiv Healthcare, MSD, TB Alliance and Otsuka.

Product registrations are an important part of enabling access to patients across geographies. We consistently file our ARV treatments with the U.S. FDA and the WHO Prequalification pathways to enable procurement by PEPFAR, the Global Fund to Fight AIDS, TB and Malaria, as well as other international agencies. Still, many countries require local registration in addition to these global approvals. To meet this need, we have steadily been filing for local market authorizations of our ARV products based on country guidelines across all key high-burden HIV countries.² 

Viatris files all relevant ARV products based on country guidelines across key high-burden HIV countries. We have more than 700 registrations of infectious disease products across LMICs.

In 2023, Viatris engaged with WHO to seek scientific advice for regulatory approval of two different medicines improving on existing molecules to better meet needs of people living with and at risk for HIV, building on our long legacy of making relevant improvements in these medicines. In 2023, the shift to consolidate treatments for patients using ARVs continued, meaning that most of the HIV programs across LMICs transitioned to a dolutegravir-based regimen across first-line, second-line and pediatric populations.

Despite significant progress made over the years, the burden of HIV remains high in many countries. Estimates indicate that around 2.47 million people in India are living with HIV.³ Viatris has been a trusted partner to the government over several years in supplying HIV medicines and in 2023, Viatris launched in India a single pill combination HIV treatment of tenofovir alafenamide, emtricitabine and dolutegravir, reaching more than 4,000 patients in the first six months it was available.

In the last two years, Viatris has launched more than 10 new ARVs in South Africa, including a darunavir/ritonavir combination used for difficult-to-treat HIV patients when initial treatments have failed or not been tolerated, as well as the first fixed-dose tenofovir alafenamide combination to be available in South Africa. This has provided patients living with HIV increased access to leading treatments, helping to improve HIV outcomes in the country and contributing to the fight against HIV.

Improving Treatment for Children Living with HIV

Protecting and improving the health of children is a fundamental global health priority. Although significant strides have been made, there are still major disparities globally, with children in LMICs being among the most vulnerable. Complexities around formulations and dosage guidelines can often be hurdles to children accessing the care they need.

We have built strong partnerships with multiple stakeholders to improve access to ARVs, with particular attention to vulnerable populations like children. For example, in partnership with Viiv Healthcare and the Clinton Health Access Initiative (CHAI), Viatris has worked to develop a dispersible form of treatment which will reduce the pill burden in pediatric populations, which hopefully will significantly improve the treatment experience for children living with HIV.

Viatris has more than 150 medicines in the 2023 Essential Medicines List for Children. This represents more than 40% of the total list.

Viatris has more than 45% of the anti-infective medicines in the Essential Medicines List for Children.

Approximately 65% of children on treatment for HIV use a Viatris product.⁴

In 2023, we received approval of a single tablet regimen – the fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg – that will reduce the pill burden for children living with HIV.

In South Africa, we provided access to leading fixed-dose combinations for children living with HIV by launching Dumiva dispersible and dolutegravir dispersible in 2023, which enable caregivers to provide easy-to-administer medication to children as opposed to syrups that can be difficult for some children to take.

These milestones support the company’s sustainability goal to provide ARV therapy equivalent to a total of 30 million patients, including more than 2 million children living with HIV/AIDS, between 2022 and the end of 2025.

The Power of Partnerships in Treating TB

Our work in infectious disease also includes a focus on TB, one of the leading causes of infectious disease deaths worldwide.⁵ In many cases, TB can be cured with an antibiotic treatment regimen for six months; however, non-adherence is a challenge for TB control and prevention programs. Non-adherence to TB treatment increases the risk of morbidity and mortality and fuels drug resistance, impacting both individuals and communities.

Through our continued partnerships, Viatris has launched pretomanid, specifically approved for adults with multidrug-resistant TB (MDR-TB). It’s only the third new anti-TB drug approved in the past half-century. It was developed by TB Alliance, a nonprofit organization that develops and delivers new TB treatments.

In 2023, we completed another 57 registrations for pretomanid, and we are awaiting approval in 10 countries, spanning across multiple continents and income levels.

Partnerships like the one with TB Alliance are essential to providing more sustainable access to medicine. Pretomanid reached patients in more than 40 countries in 2023.

Continuing Our Commitment to Prevent and Treat Hepatitis

Hepatitis is an inflammation of the liver that is caused by a variety of infectious viruses and noninfectious agents leading to a range of health problems, some of which can be fatal. For examples, types B and C lead to chronic disease in hundreds of millions of people and together are the most common cause of liver cirrhosis, liver cancer and viral hepatitis-related deaths. It’s estimated that more than 350 million people worldwide live with hepatitis B or C, and for many, testing and treatment are out of reach.⁶ We have a long tradition of helping to address hepatitis B and C, both through awareness and prevention and in making treatment more available.

Fighting TB in India

India leads the world in TB cases, a stark statistic that caused the government to set an aggressive target to eliminate TB in India by 2025.3 As many as 45,000 people are being treated for MDR TB in India. More than 10,000 of those patients were treated with a Viatris product, delamanid, in 2023. Viatris supplied this medicine through participation in a government tender and through India’s first order through the Global Drug Facility of the Stop TB Partnership, an innovative public-private partnership.

Examples from our work in 2023 include:

• In the Philippines, a partnership with PHILUSA we offered a lower priced product to patients living with hepatitis B.
• In Myanmar, in collaboration with Burnet Institute, nearly 800 hepatitis C patients were treated with MyHepDVIR at a subsidized price. This marked one of the largest treatment initiatives ever conducted for hepatitis C in Myanmar, a country that carries a disease burden of 1.3 million people living with hepatitis C.
• Collaborated in Bulgaria with the patient organization HepActive to raise awareness of hepatitis B risk factors, diagnosis and treatment adherence and to provide psychological support to patients diagnosed with hepatitis B through webinars and social media campaign.

View the full 2023 Sustainability Report.

Sources

^{1 Excludes the U.S., EU and other developed markets. Also excludes Russia, China and Mexico, where we do not commercialize ARVs 
2 WHO Global List of High Burden Countries 
3 India HIV Estimates Report 
4 Excludes the U.S., EU and other developed markets. Also excludes Russia, China and Mexico, where we do not commercialize ARVs. 
5 WHO Tuberculosis Fact Sheet 
6 WHO Hepatitis Fact Sheet}