ViiV Healthcare extends voluntary licensing agreement with Medicines Patent Pool to enable access to innovative long-acting injectable HIV treatment
Existing generic licensees for prevention will be able to develop, manufacture and supply generic CAB LA, for use in combination with long-acting rilpivirine, subject to required regulatory approvals being obtained, to help enable access to the long-acting treatment in 133 countries worldwide. This includes all least-developed, low-income, lower middle-income and Sub-Saharan African countries, as well as countries where ViiV does not have patent rights for cabotegravir.
Deborah Waterhouse, CEO at ViiV Healthcare said: 'As leaders in long-acting innovation we're proud to be expanding our voluntary licence with the MPP to now include treatment of HIV in addition to prevention. Long-acting injectables have the potential to transform HIV treatment and we welcome the latest recommendations from WHO to expand treatment options. In line with our mission to ensure no one living with HIV is left behind, we're committed to working with partners like MPP to continue to increase access and reach those most impacted by HIV.'
Charles Gore, Executive Director at MPP said: 'We're delighted to extend the CAB LA licence to cover HIV treatment, reflecting the latest WHO recommendations. Our previous agreement with ViiV for dolutegravir has already enabled the supply of generic DTG-based HIV treatments in 129 countries and we hope that over time a similar coverage can be achieved for CAB LA. CAB LA is a vital addition to the HIV treatment toolbox — especially for people facing adherence challenges with oral regimens. Expanding access to long-acting options like this supports a more person-centred, choice- and needs-driven approach, which is exactly what an equitable and effective HIV response requires.'
Dr Meg Doherty, Director Global HIV, Hepatitis and STI Programmes said:"The World Health Organization welcomes the expansion of the voluntary licence agreement for long-acting cabotegravir to include HIV treatment. This step is closely aligned with WHO's new recommendation of long-acting injectable antiretrovirals as an alternative for people who are virologically suppressed but face adherence challenges with daily oral regimens. It reflects our commitment to expanding access to innovative, person-centered treatment options that improve outcomes — particularly in underserved regions. This agreement aligns with our global goals to ensure equitable access to essential medicines and improve health outcomes for all. We are committed to supporting countries in implementing these new guidelines and ensuring that no one is left behind.'
The updated MPP-ViiV agreement is an extension of the voluntary license for cabotegravir for HIV PrEP. ViiV Healthcare has been supporting the generic manufacturers with technical know-how to enable development and access to CAB LA as soon as possible.
Through the agreement, the existing licensees, Aurobindo, Cipla and Viatris, will be able to develop, manufacture and supply generic versions of CAB LA, for use in combination with long-acting rilpivirine, for the treatment of HIV-1 infection in adults and adolescents weighing at least 35kg, subject to required regulatory approvals being obtained.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
About Apretude (cabotegravir long-acting)
Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir.
Please consult the full EU Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection
About Vocabria (cabotegravir)
Vocabria injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.
Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:
oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.
oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.
Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant (rilpivirine) tablets should also be consulted for recommended dosing.
Please consult the full EU Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets
About Rekambys (rilpivirine)
Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.
Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection).
Please consult the full EU Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company's aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.
About MPP
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP's main funder. MPP's work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP's activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the 'Risk Factors' section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
New York Post
21 minutes ago
- New York Post
NYC banking exec dead after hiking Wyoming peak six times during ‘Everesting' endurance challenge
A Big Apple banking executive and father-of-three died after quickly hiking up and down a Wyoming peak six times during an 'Everesting' endurance challenge. Slava Leykind, 43, of Westport, Connecticut, went into cardiac arrest after competing in the event at Snow King Mountain in Jackson Hole late last month. The endurance-style event sees hikers repeatedly trek 1,500 feet up the mountain to match climbing Mount Everest — the world's tallest peak at 29,032 feet. 3 Connecticut banker, Slava Leykind, with his wife and children Amy Keller Leykind / Facebook 3 Flat Creek and the Snow King ski resort in Jackson, Wyoming. Christopher Boswell – Leykind managed to complete six laps before first responders were called in and he was rushed to the Eastern Idaho Regional Medical Center in Idaho where he died on July 2, Jackson Hole News & Guide reported. His cause of death was a 'an electrolyte imbalance causing cardiac arrest,' the Teton County Coroner said. Leykind, who lived in Westport with his wife and their three kids, was an exec at the New York City-based investment bank, CG Sawaya Partners, where he'd worked for two decades, according to his LinkedIn. 3 Dad of three Slava Leykind died during an endurance challenge. Amy Keller Leykind / Facebook 'Despite his significant professional success at a young age, Slava's role as a husband and father was his greatest achievement, passion and pride,' his obituary said. 'He fervently supported his children, bringing love and a sense of calm to the wonderful chaos of a full house.'
Chicago Tribune
an hour ago
- Chicago Tribune
Groups that support LGBTQ+ individuals brace for funding cuts that could affect HIV care, prevention
Chicago-area groups that support LGBTQ+ individuals are navigating an uncertain landscape while bracing for federal funding cuts that could affect HIV care and prevention. Cuts outlined in President Donald Trump's proposed 2026 budget mean some groups stand to lose federal funds that support medical services like testing and HIV treatment, as well as nonmedical patient supports such as housing and food subsidies. Research money that goes toward drug development is also on the chopping block. Advocates say that because the virus disproportionately affects transgender, Black and Latino individuals — and prevention efforts have been focused on those communities — HIV funding has taken a hit as diversity, equity and inclusion programs are rolled back. 'When we allocate funds to prioritize the needs of this community, it's a community that has been impacted by health disparities since before we've been counted by the census,' said Terra Campbell, associate director of community relations at LGBTQ+ health care provider Howard Brown Health. 'It's not special treatment. It's investment in the needs of your neighbor and the community.' The Midwest AIDS Training and Education Center's funding will be cut completely in the current budget proposal for fiscal year 2026. It provides training and support for health care professionals working in HIV prevention, care and treatment. Shanett Jones, Illinois program director, estimates the center trains more than 4,000 providers every year. The center receives funding under the Ryan White HIV/AIDS program, the largest federal program for HIV in America. The 2026 budget proposal eliminates the part of the Ryan White program that establishes and funds all AIDS education and training centers across the United States. 'If we do lose this funding, we risk having a less prepared workforce, which leads to delayed diagnosis of people living with HIV,' Jones said. 'This is an infrastructure that, once it's dismantled, it does not come back easily — you can't win the race by slashing the engine.' AIDS Foundation Chicago gets more than 80% of its funding from federal sources. Alongside advocacy work, the foundation provides support services for people living with HIV, including testing and prevention resources, education, housing and health insurance. In 2024, the foundation served more than 8,000 people in the Chicago area. Timothy Jackson, senior director of policy, said the foundation is currently planning for a projected loss of 40% of those funds in the president's 2026 budget request. AIDS Foundation Chicago is partially funded by both Ryan White and the Centers for Disease Control and Prevention. According to KFF, a nonprofit health policy research organization, the proposed budget cuts all of the CDC's HIV prevention funds. The foundation also receives funding through the Housing Opportunities for Persons with AIDS program, which will also be eliminated in the proposed 2026 budget. These nonmedical services are essential for reducing HIV in Chicago, Jackson said. 'We have to look at all of the other things that make HIV possible, or make the transmission of HIV possible. So that's when we talk about housing, that's when we talk about harm reduction. That's why we talk about transportation and food access and all of these other different things,' he said. AIDS Foundation Chicago filed a lawsuit in February along with two other nonprofits challenging executive orders that sought to end 'diversity, equity, inclusion, and accessibility' programs and equity-related grants and contracts. 'Our mission is rooted in ending HIV and homelessness in the communities that are most impacted. And it is very difficult to do that when you are not leading with equity,' Jackson said. These organizations' work has already been affected by the National Institutes of Health funding pause earlier this year, and will continue to be affected by cuts to research funding in the planned budget. Jackson said the recent success of the twice-annual HIV prevention shot, lenacapavir, would not have been possible without NIH and CDC funding. 'This administration does not value science. We see that play out over the huge cuts at the CDC, the National Institutes of Health, which all impact HIV and the work around new HIV treatment and prevention modalities,' Jackson said. Even groups that are not largely reliant on federal funding are experiencing the strain of an uncertain economic future. Chris Balthazar, executive director of TaskForce Prevention and Community Services, a health and wellness group serving LGBTQ+ youth in Chicago, says many of his organization's partners are only signing contracts for quarterly periods, instead of their usual 12-month periods, in case funding disappears. These partners are how TaskForce provides many of its services, which include legal and housing aid, HIV and other STD testing, and connecting patients to medical care. 'Imagine what the impact of that is on the ground. How do you sustain a job on a grant that you don't even have a full 12-month contract for?' he said. Additionally, Balthazar explained that while state funding is not being cut as explicitly as federal funding, it is still expected to decline. The federal government partially funds the Illinois and Chicago Departments of Public Health, which then give grants to groups like TaskForce. Since the health departments don't know what sort of funding to expect in the next year, they aren't able to commit to the same grants they have in years previous. 'So much of the state budget comes from the federal budget. And I think that it's scary that, unfortunately, if this continues and nothing is undone, we're going to see major cuts, and we're going to see more and more people who are on the margins of the margins be even more drastically devastated by this,' he said. Both Jackson and Jones said that the most important thing anyone can do for HIV care and prevention in Chicago right now is to call their representatives and express support for continued HIV funding. 'It's reassuring that we have people who are still engaged, who are still advocating, who are still hoping. And when I go and I talk to community groups, I tell them, we can't go back to the '80s,' Jackson said. 'We're going to do what we have always done in 40-plus years of the epidemic: rely on community to get us through.'
Medscape
an hour ago
- Medscape
PEPFAR Spared, but Concerns About Global HIV Response Remain
Experts are expressing relief that the US President's Emergency Plan for AIDS Relief (PEPFAR), a $7.5 billion program credited with saving 26 million lives around the world from HIV, was spared millions of dollars in spending cuts. Last week, the US Senate removed a proposed $400 million reduction in PEPFAR funding from the $9 billion rescission package put forward by President Donald Trump after objections from Democrats and a handful of Republicans. The PEPFAR program, which was set up by President George W. Bush in 2003, provides treatment to two thirds of all patients with HIV across more than 50 countries and has allowed almost 8 million babies to be born healthy to mothers with HIV. 'This isn't a full reset, but it's meaningful,' Jirair Ratevosian, DrPH, a former senior advisor to PEPFAR, told Medscape Medical News. Members of both parties in Congress have found the administration's justifications for the cuts to be deceptive, he added. The blocking of the cuts is 'also a sign that Congress is willing to exert oversight and send a clear message globally: The US is not walking away from the HIV fight.' Ratevosian is an associate research scientist at Yale University in New Haven, Connecticut, with a primary focus on HIV prevention. 'It gives PEPFAR breathing room to continue planning country transitions — something the Trump administration claims to prioritize — and to support innovative programming, including HIV prevention using AI [artificial intelligence],' Ratevosian said. PEPFAR's Future Uncertain But while activists and experts welcomed the news, the future of the program remains uncertain. It is now administered by the US State Department, with little detail about how and where services will be delivered. 'The decision is a testament to the power of global health activism, but it is important to realize that all this does is ensure that $400 million that had already been allocated to be spent on fighting HIV doesn't get spent by Trump,' Asia Russell, executive director of Health GAP, an international organization focused on access to HIV medicines, told Medscape Medical News. Some organizations that are implementing PEPFAR have taken Trump's budget cuts to indicate that they should stop intervening among priority populations like trans patients, gay men, and sex workers. 'Any effective infectious disease response must focus on communities who have an elevated risk of HIV acquisition or poor clinical outcomes.' In a recent report, the Joint United Nations Programme on HIV and AIDS (UNAIDS) said that the weakening aid consensus and significant and abrupt funding shortfalls in the HIV response had triggered widespread disruption across health systems, halting HIV prevention programs and jeopardizing treatment services. UNAIDS predicted an additional 6 million new HIV infections and 4 million additional AIDS-related deaths worldwide between 2025 and 2029 resulting from the collapse of US funding. Ukraine has an estimated 245,000 patients with HIV, which is the second highest prevalence in Europe after Russia. Dmytro Sherembey, head of Ukraine's largest patient-led HIV organization, 100% Life, told Medscape Medical News that his organization had been forced to cut its expenses by 30%. He credits his own survival of HIV to US aid. 'These past few months have been incredibly difficult. Amid the war in Ukraine, we faced the terrifying risk of losing essential funding from PEPFAR. Prevention, awareness, advocacy, and community support programs — key drivers in the HIV response — were hit the hardest,' he said. 'The decision [not to cut funding] brings hope and stability. It means children won't lose parents, parents will have healthy babies, and people in Ukraine will keep accessing life-saving care.' Additional Threats Remain In April, UNAIDS said that Ukraine's national preexposure prophylaxis (PrEP) program was at high risk because of halted procurement. Its current supply is expected to be exhausted by mid-August 2025. 'In Ukraine, we count on the US decision that PEPFAR will continue to fund PrEP,' Andriy Klepikov, PhD, executive director of the Alliance for Public Health, told Medscape Medical News. The Alliance for Public Health is one of the largest HIV-focused nongovernmental organizations in Ukraine and the wider region. Andriy Klepikov, PhD 'We hope that PEPFAR will continue PrEP for key populations (not only for pregnant and breastfeeding women), but there is no confirmation yet,' he added. But while PEPFAR has been spared, additional threats to the global HIV response remain. The United States Agency for International Development (USAID) has been dismantled, the administration has cut nearly $1 billion in HIV funding at the National Institutes of Health, and the CDC's Division of HIV Prevention has been cut significantly. 'There's no sign that the funding of USAID will be restored. Much of the local support for HIV was funded by USAID, such as HIV testing, outreach workers, and support for key populations,' said Andrew Hill, MD, PhD, senior visiting research fellow in the Department of Pharmacology and Therapeutics at the University of Liverpool, Liverpool, England. Andrew Hill, MD, PhD He cited a recent The Lancet paper that suggested that ongoing deep funding cuts could result in more than 14 million additional deaths by 2030. 'If 14 million people do indeed die early as a result of US cuts, this would be the greatest loss of life from any US presidency since World War II.'
