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

Informations

• Publié par: feinstein-kean-healthcare
• Nombre de lectures: 9
• Langue: English

Extrait

ViiV Healthcare Expands Commitment to

Addressing Gaps in Paediatric HIV Research,

Care and Treatment

PR Newswire

LONDON, July 18, 2012

-

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.

Media contacts

UK Media enquiries:Camilla Bull

+44 (0) 20 8380 6226

Catherine Hartley+44 (0) 20 8047 5616

US Media enquiries:Marc Meachem

+1 (919) 483 8756

[i] WHO, UNAIDS and UNICEF, Global HIV/AIDS response: epidemic update and

health sector progress towards universal access: progress report 2011,

Geneva

, 2011.