NORTHAMPTON, MA / ACCESS Newswire / October 21, 2025 / Viatris has a long history in the fight against infectious disease, which accounts for eight of the top 10 causes of death in low-income countries.1 We are working with global and local partners to help prevent infections, increase access to diagnosis and treatment, provide healthcare solutions and work on local manufacturing initiatives with partners to transfer technology to expand access where it is most needed.
In 2024, Viatris focused on expanding access to HIV treatments, second-line tuberculosis (TB) treatments, anti-malarial products and injectables to Africa, North and South America, Eastern Europe and East Asia, regions that are experiencing an increase in new HIV infections and high-burden countries for drug-resistant TB.
We are also working with the Drugs for Neglected Diseases initiative (DNDi) for the development of Flucytosine SR formulation, which will be used in the treatment of cryptococcal meningitis, a devastating fungal infection that people with HIV are especially susceptible to developing. Often, treatments for cryptococcal meningitis are not available or affordable in areas where the burden is most severe.2
Supplied ~50% of medicines on the WHO EML anti-infective medicines section and ~45% of medicines on the WHO EML for Children anti-infective medicines section
The Need to Remain Focused on HIV Treatment
Progress in preventing and treating HIV has been uneven across the world. While sub-Saharan Africa has experienced the steepest reductions in new infections, Eastern Europe and Central Asia, Latin America, and the Middle East and North Africa are experiencing an increase. Overall, the global numbers of new HIV infections are not declining fast enough. Almost a quarter of people living with HIV are not receiving lifesaving treatment and every minute a person dies from AIDSrelated causes.3
Viatris provides access to high-quality and more affordable ARVs to approximately 125 countries. Viatris has 32 HIV/AIDS products on the WHO's list of prequalified products.
The market dynamic is evolving and, in 2024, we saw regimen consolidation for pediatric patients on anti-retroviral therapy, with most of the HIV programs across the low- and lower-middle income countries transitioning to triple combination drug: Abacavir/Lamivudine/Dolutegravir 60/30/5. Regarding the PrEP (Pre exposure Prophylaxis) market, there is a considerable push for adoption of long-acting injectables for prevention therapy. Over the years, Viatris has procured license to develop, manufacture and commercialize the following long acting PrEP injectables in low- and middle-income countries: (i) Lenacapavir from Gilead Sciences Ireland UC (2024); and (ii) Cabotegravir from the Medicine Patent Pool (2023).
Product registrations are important to expanding access to ARV products as it helps global procurement agencies deliver the medicines to customers faster. This is important especially for meeting the UN SDG target of ending the HIV/AIDS epidemic by 2030.
We consistently file our ARV treatments with the U.S. FDA and the WHO Prequalification pathways to enable procurement by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the Global Fund to Fight AIDS, TB and Malaria, as well as other international agencies. Many countries require local registration in addition to these global approvals. To meet this need, we have steadily filed for local market authorizations of our ARV products based on country guidelines across all key high-burden HIV countries.4
We have local manufacturing facilities in Zambia, South Africa, and via Viatris' partners in Mozambique and Kenya. Technology transfer agreements were made for key antiretrovirals to help expand access. By having presence for manufacturing and packaging in South Africa, Viatris is helping to develop local capacity, competency and experience with high-quality production. In addition, we have been working with global procurement agencies and distributor partners to store essential and high-priority products at the South Africa warehouse to enable supply with a short lead time.
Approximately 25% of the world's adults and >50% of the world's children on treatment for HIV use a Viatris product. We supply products that address HIV/AIDS for all lower- and lower-middle-income countries in which this is a leading cause of death.
In 2024, we launched the fixed-dose combination of isoniazid, pyridoxine, sulfamethoxazole and trimethoprim and pediatric and adult formulations of the fixed-dose combination of abacavir, dolutegravir and lamivudine, helping to reduce the pill burden across low- and middle-income countries.
Through our ongoing work with the Bill and Melinda Gates Foundation and the Children's Investment Fund Foundation, we progressed work on development of a dual oral pill for HIV and birth control. The Dual Pill (TELE) has been submitted for WHO prequalification approval.
Barriers to effective treatment for people living with HIV include limited testing and lack of data for TAF-based treatments. TAF-based treatment in HIV involves the use of Tenofovir Alafenamide, a prodrug of tenofovir, which is preferred for its improved safety profile. It is used in combination with other antiretroviral agents in certain treatment regimens to effectively suppress the HIV virus and improve patient health. Viatris is helping to address these barriers through the promotion of HIV Self-Tests and scaling up of TAF-based treatments in various countries.
We have >700 registrations of infectious disease products across LMICs.
Viatris has seven 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.
Our HIV Treatment Access Goal
Goal: Provide ARV therapy equivalent to a total of 30 million patients, including >2 million children living with HIV/AIDS, between 2022 and the end of 2025.*
Our Progress: In 2024**, we provided treatments for ~7 million patients, including ~320,000 children living with HIV/ AIDS. Since 2022, we have provided treatments for >24 million adults and children.
*Our ability to make progress on our goal depends on several factors, some of which are outside of our control, including the existence and funding of our distribution partners.
** The remediation activities at the Indore site have impacted our ARV therapy supply in 2024. We are aiming to be back on track by the end of 2025.
Expanding access to Malaria Treatment
In 2024, Viatris signed a volume agreement with the Bill and Melinda Gates Foundation and MedAccess for a daily dose treatment as a replacement for the existing combination medicine used to treat non-severe malaria, which is facing growing resistance.
The new treatment - artesunatepyronaridine (ASPY) - is indicated for all malarias, including multidrugresistant falciparum malaria.
Malaria is visibly impacted by the changing climate - as the climate warms, mosquitoes able to transmit the disease are spreading to new areas and living year-round in places where they were formerly only seasonally active. People who previously were not at risk for malaria, and who have no immunity to the disease, will be increasingly susceptible. Instead of reaching an end to malaria by 2030, we may be facing a global resurgence.
Viatris' portfolio holds treatments for malaria, with two products on the WHO list of qualified products and collaboration with partners to expand access.
The Fight Against TB
Viatris works to help end TB, one of the leading causes of infectious disease deaths worldwide. 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.
In 2024, we continued to expand access to pretomanid, specifically approved for adults with multidrug-resistant TB (MDR-TB). When it was launched in 2020 through partnership with TB Alliance, a nonprofit organization that develops and delivers new TB treatments, it was the third new anti-TB drug approved in the past half-century.
We work with key procurement agencies like the Global Drug Facility to provide accessible pricing and expand our reach to more than 100 countries. We also have an agreement with MedAccess for pretomanid that enables us to supply the product to all emerging market countries at a single access price.
In 2024, we completed five registrations for pretomanid and we are awaiting approval in six countries. In all, we have 64 current registrations for pretomanid spanning across multiple continents and income levels. Further, we have seven TB products on the WHO's list of prequalified products. Partnerships like the one with TB Alliance are essential to providing more sustainable access to medicine.
Tackling HIV in Thailand
HIV/AIDS is a key public health priority for the government in Thailand. Viatris continued its collaboration in 2024 with the Government Pharmaceutical Organization to provide ARVs at a reduced cost to improve access for patients.
Understanding the Stigma of TB
TB persists as one of the world's leading causes of infectious disease death, the leading cause of death for people living with HIV, and one of the major contributors to antimicrobial resistance.5 Viatris is actively engaged in and contributes to the leadership of the Private Sector Constituency (PSC) for the global Stop TB Partnership with the primary focus to achieve a world free of TB and, until then, making diagnosis, treatment and care available to all who need it.
Much progress6 was made in 2024 by the Partnership, including a record number of people diagnosed and treated for TB, an increase in TB programs focused on respecting the rights of people living with TB and being gender-sensitive, numerous country level stigma evaluations, and assessments of key and vulnerable groups. 2024 saw the highest-ever number of countries implementing One Impact - the only communityled monitoring tool used by the Stop TB Partnership - and a stronger, more coordinated civil society. Throughout 2024, the PSC stressed the role of the private sector in developing, introducing and supplying at scale TB treatments, vaccines, diagnostics and digital solutions for TB programs globally.
Creating Life-Saving Access for TB Patients
The Pretomanid Named Patient Access Program (NPAP) allows a treating physician to submit a request for pretomanid prior to regulatory approval in their respective country on a named-patient basis. In this program, Viatris receives an initial request from the treating physician from Viatris Pretomanid Named Patient Access Program on the website. The treating physician fills out anonymized patient information forms containing all the medical details and submits the request. Once the treating physician submits the request, it is reviewed by Viatris' partner, TB Consilium, a multidisciplinary team of experts that helps manage difficult-to-treat tuberculosis cases. The team independently evaluates the request for the eligibility of the patient for receiving pretomanid. Once TB Consilium approves the patient's eligibility for receiving pretomanid, Viatris reaches out to the treating physician for appropriate documents to ship the product to the requested location.
In 2024, the Pretomanid Named Patient Access Program successfully supported 28 patients, providing them with access to life-saving treatment that would otherwise be unavailable.
View the full Viatris 2024 Sustainability Report.
Sources
1 The top 10 causes of death
2 Cryptococcal meningitis | DNDi
3 2024 global AIDS report - The Urgency of Now: AIDS at a Crossroads
4 WHO global lists of high burden countries for tuberculosis (TB), TB/HIV and multidrug/ rifampicin-resistant TB
5 Tuberculosis Stop
6 TB annual report
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SOURCE: Viatris
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https://www.accessnewswire.com/newsroom/en/industrial-and-manufacturing/how-viatris-is-fighting-infectious-disease-1089996
