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[e-drug] Medicines Patent Pool Signs agreement with MSD for Paed Raltegravir Formulations

E-DRUG: Medicines Patent Pool Signs agreement with MSD for Paed Raltegravir 
Formulations 
------------------------------------------------------------------------------------------------------------------------------

The Medicines Patent Pool Signs Licensing Agreement with MSD for Paediatric 
Formulations of Raltegravir
The Company joins five other MPP patent holders in efforts to improve HIV 
paediatric care

(GENEVA, 24 February 2015) — The Medicines Patent Pool (MPP) announced a 
licence today with MSD, known as Merck in the United States and Canada, for 
paediatric formulations of raltegravir, a key medicine approved for children 
living with HIV four weeks of age and older. With the new licence, generic 
manufacturers and other companies based anywhere in the world can develop, 
manufacture and sell low cost, paediatric versions of raltegravir in countries 
with the highest burden of disease, where 98 percent of children with HIV in 
the developing world live.

“MPP is pleased to have MSD on board as a new private sector partner working 
with us on paediatric programmes,” said Greg Perry, Executive Director, MPP. 
“Raltegravir adds to our arsenal of paediatric licences in supporting better 
options for children in low- and middle-income countries and can benefit the 
most neglected sub-segment: infants and toddlers less than three years of age.”

“PEPFAR applauds the new MSD license as part of international efforts to 
greatly improve the lives of infants and children living with HIV/AIDS,” said 
Ambassador Deborah L. Birx, M.D., U.S. Global AIDS Coordinator and U.S. 
Representative for Global Health Diplomacy. “Without antiretroviral treatment, 
50 percent of infants living with HIV/AIDS will die by the age of two, and 80 
percent by the age of five. We need a range of optimal, affordable paediatric 
antiretroviral drugs to scale up treatment and put the right medicines in the 
right formulations in the hands of caregivers globally.”

The World Health Organization recommends raltegravir as a component of 
paediatric third-line treatment. Its recent extended approval for infants as 
young as a month suggests its potential in filling an important gap in 
paediatric care. The medicine’s current availability as chewable tablets and 
granules for oral suspension could potentially ease implementation in 
paediatric programmes. The medicine is currently in clinical studies for 
potential use in newborns.

“This agreement with MPP has been established to provide access to raltegravir 
to HIV-infected children in developing countries where the burden of HIV 
infection is highest, including sub-Saharan Africa,“ said Jackie Neilson, 
General Manager and Global Commercial Leader for the HIV Franchise, MSD. “This 
builds upon MSD’s three-decade long commitment to both innovation and access to 
address the global HIV epidemic.”

The agreement comes just two months after MPP signed a licence with AbbVie for 
paediatric versions of lopinavir and ritonavir and supports the work of the 
Paediatric HIV Treatment Initiative (PHTI), a collaboration among MPP, UNITAID, 
the Drugs for Neglected Diseases initiative (DNDi) and the Clinton Health 
Access Initiative (CHAI), to develop better, adapted HIV paediatric medicines. 
In December, PEPFAR, the Global Fund and the PHTI joined together in a Global 
Paediatric Antiretroviral Commitment-to-Action to ensure that new PHTI 
formulations will be made widely available. The PHTI has recognized raltegravir 
as an important product for children who fail on their first-line regimens.

The MSD licence territory focuses on low- and middle-income nations with 
significantly high rates of paediatric HIV, totalling 92 countries. Under the 
terms of the agreement, generic manufacturers have the right to reformulate 
raltegravir formulations for use in combination with other HIV medicines and 
for distribution in resource-limited settings.

The full MPP licensing agreement is available at www.medicinespatentpool.org.

About the Medicines Patent Pool (MPP)

The Medicines Patent Pool is a United Nations-backed organisation offering a 
public-health driven business model that aims to lower the prices of HIV 
medicines and facilitate the development of better-adapted HIV medicines, such 
as simplified “fixed-dose combinations” (FDCs) and special formulations for 
children, through voluntary licensing and patent pooling.  Founded by UNITAID 
in 2010, the MPP works with a range of stakeholders — communities of people 
living with HIV, governments, industry and international organisations. To 
date, MPP has signed agreements for twelve antiretrovirals (ARVs) for countries 
home to 87-94% of people living with HIV in the developing world and for one 
medicine for an HIV opportunistic infection. MPP, together with UNITAID, the 
Drugs for Neglected Diseases initiative  (DNDi) and the Clinton Health Access 
Initiative (CHAI), is a partner in the Paediatric HIV Treatment Initiative 
(PHTI) to accelerate the development of appropriate paediatric FDCs for 
resource-limited settings.

Contact:
Katherine Moore
Head of Communications
Medicines Patent Pool
Tel: +41 22 533 5054 | Mobile: +41 79 825 4786
kmoore@medicinespatentpool.org

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