Johnson & Johnson : Works with U.S. PEPFAR Program to Expand Access for HIV Treatment-Experienced Children in the Developing World

Together We Intend to Overcome Barriers to Access Treatment and Secure Supply of Pediatric Antiretroviral Therapy Formulations

Vatican City, Dec. 7, 2018 - Johnson & Johnson today announced that Janssen Pharmaceutica NV, part of its Janssen Pharmaceutical Companies, is working with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) with the intention of expanding access to lifesaving HIV antiretroviral therapy (ART) for children in the developing world. The initiative seeks to address the fact that only about half of children under age 15 in the developing world are benefiting from ART. This was announced at a conference on pediatric HIV care taking place today in the Vatican City.

'In recent years, we have seen an expansionin access to HIV therapies in developing countries, but for too many of the world's children, these medicines have been out of reach,' said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. 'Together with PEPFAR, and other global partners, our goal is to extend availability to the young by ensuring that children and adolescents living with HIV have access to sustainable, high-quality, and appropriate treatment.'

Worldwide, approximately 1.8 million children under age 15 have HIV, and almost 90% are living in sub-Saharan Africa. Only 52% of these children are on HIV treatment. Even with ART, rates of treatment success for children and adolescents are consistently lower than those for adults across Africa. Studies have shown that most children failing ART have evidence of drug resistance, highlighting the urgent need for follow-on (second- or third-line) treatment regimens towhich resistance has not developed.

To accelerate the expansion of HIV treatment access to children, particularly those in need of follow-on regimens, Janssen will work to provide sustainable access to a pediatric formulation of its medicine, darunavir 75mg. Working with the United States Agency for International Development, through PEPFAR,we are developing an alternate procurement model to overcome the current lack of market incentives for generic manufacturers to supply pediatric antiretroviral medicines such as darunavir. While these medicines are critical for children in need of alternative HIV therapies, currently they are requested andpurchased in relatively small quantitiescompared to similar medicines for adults, which represents a challenge for generic manufacturers.

'We've made tremendous progress in delivering HIV therapies to people in developing countries, overall, but we need to do better for children,' said Ambassador Deborah L. Birx, M.D., U.S. Global AIDS Coordinator & U.S. Special Representative for Global Health Diplomacy. 'Children are more prone to developing drug resistance to first-line therapies, and yet the supply of the second-line medicines they need is constrained. By working together with innovator companies like Johnson & Johnson, as well as generic manufacturers, PEPFAR isdetermined to address this critical gap.Because we know that if we don't take actionnow, the pediatric HIV care challenge will only grow.'

For nearly five years Janssen has been working to address the needs of this significantly underserved population in sub-Saharan Africa. In 2013, Janssen launched the New Horizons Collaborative, a first-of-its-kind pediatric HIV treatment donation program now available in 10 countries, to provide darunavir and etravirine, including child-friendly formulations, free of charge to eligible countries with the clinical capacity and willingness to address second- and third-line pediatric HIV treatment. Learn more about the program here: http://www.newhorizonshiv.com.

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Johnson & Johnson's Commitment to Make HIV History

Johnson & Johnson has a 25-year heritage of working to end the AIDS epidemic. Our Janssen Pharmaceutical Companies have brought eight HIV therapies to market. We are committed to working with our global partners in the quest to #MakeHIVhistory. To achieve this goal, we are working strategically across three key fronts: prevention, treatment and the search for a cure.Specifically, we are:

• Advancing innovative new HIV prevention tools, including a 'global vaccine' in development at our Janssen Pharmaceutical Companies
• Bringing new, innovative and simpler treatment options from Janssen to children, adolescents and adults living with HIV
• Exploring novel HIV cure strategies, including the potential role of therapeutic vaccines in achieving a functional cure

Additionally, the Johnson & Johnson Family of Companies collaborates with numerous patient advocacy groups and supports more than 100 philanthropic programs in more than 50 least-developed countries to address the needs of people living with HIV/AIDS.

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @jnjglobalhealth.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal. Janssen Pharmaceutica N.V.is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.