ViiV Healthcare Expands Commitment to Addressing Gaps in Paediatric HIV Research, Care and Treatment

- ViiV Healthcare Collaborates with Clinton Health Access Initiative (CHAI) & Mylan Pharmaceuticals on First-of-its-Kind Agreement to Provide a Paediatric Dispersible Fixed Dose Combination for Treatment of HIV

- Establishes Five New Partnerships to Promote Paediatric HIV Research, Treatment and Care Initiatives

LONDON, July 18, 2012 /PRNewswire/ -- ViiV Healthcare today announced a broad range of groundbreaking initiatives as part of its ongoing commitment to address the gaps in care and treatment of paediatric HIV. These efforts are part of the company's Paediatric Innovation Seed Fund. They include a public-private partnership with CHAI and Mylan Laboratories Limited, a subsidiary of US-based Mylan Inc., to submit a registration file for a new dispersible formulation of a fixed dose combination for paediatric patients in resource-limited settings. ViiV Healthcare is also providing grants of nearly 3 million pounds to five organisations to improve paediatric HIV research, care and treatment access in resource-limited settings. Taken together, these new initiatives bring ViiV Healthcare's level of support to approximately 5.3 million pounds of the total 10 million pounds committed since the introduction of the Paediatric Innovation Seed Fund in 2009.  

There has been significant progress over the past decade in increasing access to high quality treatment for children living with HIV. However, too many HIV-positive children still do not have adequate access to HIV treatment and care. An estimated 3.4 million children under the age of 15 are living with HIV, with approximately 90 per cent of them living in Africa.[i]  Among those, an estimated 2.1 million children require immediate treatment, while only 23 per cent are receiving it, compared to nearly 51 per cent of adults. Improvements in access to treatment and quality of care are urgently needed in this population with a particular focus on resources targeted towards identification, initiation and retention on antiretroviral treatment. Access to appropriate therapeutic options for infants and children which simplify treatment initiation and promote adherence and retention remains a major unmet need in global HIV care. Among several barriers preventing further scale-up of the numbers of children on treatment are a lack of a clear evidence base for the best approaches to care and a lack of low-cost formulations that are palatable and acceptable for use by children - which also ease administration challenges and improve compliance.

In addition to the CHAI and Mylan partnership, ViiV Healthcare has identified five organisations to receive unrestricted educational grants to support programmes which will help improve paediatric HIV treatment and care through the collection of data, information and research. These organisations include The International AIDS Society (IAS), JUSTRI – the Training Resource Initiative, Mater Misericordiae University Hospital, amfAR's TREAT Asia Programme, and the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). 

"Although children and infants are one of the most underserved and vulnerable populations in the HIV epidemic there are few commercial incentives to develop appropriate HIV drugs.  ViiV Healthcare's innovative product development partnership with Mylan seeks to address this challenge and is designed to facilitate the introduction and cost effective supply of a formulation to help meet the needs of infants and children," said Alan Staple, Strategic Relationships Manager, the Clinton Health Access Initiative.

ViiV Healthcare's Collaboration with Clinton Health Access Initiative
In 2010, CHAI and ViiV Healthcare established a non-monetary Memorandum of Understanding (MOU) to work together on meeting the needs of children living with HIV, with a particular emphasis on addressing challenges in the developing world. The first outcome of this agreement is a novel public-private partnership, in which ViiV Healthcare oversees and funds the clinical development and regulatory filing process for a dispersible formulation of abacavir/lamivudine which in a fixed-dose combination form is not generally recommended for children because of the inability to dose-adjust. Under the terms of the MOU, ViiV Healthcare commits to transfer the necessary technology and resources to Mylan Laboratories to facilitate regulatory authority submission and, if approved, support production and distribution of the new formulation at low cost for a total of 115 resource limited countries including all low income, least developed countries and sub-Saharan Africa. This is the first time a pharmaceutical company has fully funded the entire development process in order for a generic company to manufacture and distribute an HIV medication in the developing world.  

One of the major challenges in treating children living with HIV is finding formulations that are easy for children to take and easy for non-specialist providers to prescribe to children of different weights and ages. Infants who are too young to swallow tablets need antiretrovirals that are more child friendly such as syrups, powders, dispersibles, sprinkles or 'melts' but these formulations are not widely available. In addition, some of these formulations have an unpleasant taste, making them difficult for children to take daily. This new dispersible paediatric formulation will taste of strawberries, and will be developed and submitted for approval for children as young as twelve weeks for use as part of their overall treatment regimen.

"Barriers to treatment and services for HIV are a significant challenge for adults around the world and are even more difficult for children with HIV," said Dr Dominique Limet, CEO, ViiV Healthcare. "These agreements are a significant step forward in breaking down some of these barriers, expediting the delivery of medicines and supporting local programmes to help infants and children affected by HIV."

Five Additional Partner Grants  
The grants provided by ViiV Healthcare will cover a two year period and each of the following five organisations will focus on a unique activity or geographic region:

• amfAR's TREAT Asia Programme will identify gaps in paediatric HIV research and training, and highlight issues and direct interventions in order to impact broader paediatric and adolescent HIV communities in Asia; 
• Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) will continue current efforts to improve access in three existing pilot sites in Malawi. The projects will focus on better understanding of key gaps in care and testing potential solutions, with the aim of increasing access to early infant diagnosis and treatment services through pilot programmes in new districts;
• JUSTRI – the Training Resource Initiative will partner with experts in Romania, UK and Eastern Europe to develop and lead a consortium to coordinate an observational, cross-sectional and longitudinal follow up study of children living with HIV;
• International AIDS Society (IAS) will promote paediatric HIV research with the aim to optimise the quality of treatment and care services for children affected by HIV in resource-limited settings;
• Mater Misericordiae University Hospital will develop a consortium of stakeholders to lead an observational cross-sectional two year follow up of 2,000 HIV infected children, 1,500 of whom are currently treated at outpatient clinics in the city of East London, Eastern Cape Province of South Africa.

These efforts are directed at eliminating barriers that impede access for children including health worker discomfort with testing and treating young children, logistical challenges with testing, limited community awareness and inconsistent national policies. These initiatives will contribute to an increased understanding of the best approaches to improve HIV treatment and care for infants and children.

About ViiV Healthcare's Paediatric Innovation Seed Fund 
Established in 2009, the Paediatric Innovation Seed Fund is part of ViiV Healthcare's ongoing commitment to deliver innovation in the areas of highest unmet need in HIV. The 10 million pounds seed fund specifically supports partnerships with organisations that focus on improving and accelerating the evidence base for paediatric care and treatment, the research and development of paediatric fixed-dose combination (FDC) products, and formulations for the treatment of infants and children living with HIV. To find out more about this in the words of our partners, please visit: www.viivhealthcareeffect.com

About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established by GlaxoSmithKline (LSE: GSK.L) and Pfizer (NYSE: PFE) to deliver advances in treatment and care for people living with HIV. Our aim is to take a deeper and broader interest in HIV/AIDS than any company has done before, and take a new approach to deliver effective and new HIV medicines as well as support communities affected by HIV.  For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com

About Mylan 
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories. Our workforce of more than 18,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. www.mylan.com

Note to Editors 
Dr Dominique Limet, CEO, ViiV Healthcare will chair a press briefing titled 'Paediatric HIV: Turning the Tide Together', 25th July, 4pm EDT, Press Room 1, International AIDS Conference, Conference Centre, Washington, DC.

Senior Executive Panellists from leading HIV research and service delivery organisations including CHAI, Mylan, International AIDS Society, amfAR's TREAT Asia Programme and Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) will discuss their respective ViiV Healthcare grant awards and will address the challenges and unmet needs of paediatric care and treatment.

[i] WHO, UNAIDS and UNICEF, Global HIV/AIDS response: epidemic update and health sector progress towards universal access: progress report 2011, Geneva, 2011.