Medicines Patent Pool Adds Two AbbVie Paediatric HIV Medicines

The Medicines Patent Pool (MPP) has announced a licence agreement with pharmaceutical manufacturer AbbVie to allow the production of cheaper, more accessible paediatric versions of two HIV medicines.

Announced on World AIDS Day, the agreement is aimed at providing children living with the virus with easier to use, more affordable medicines.

The agreement is for lopinavir (LPV) and ritonavir (r), top World Health Organization-recommended medicines for children, MPP said. “The licence will enable other companies and organisations to re-formulate and manufacture specially designed LPV/r and r paediatric treatments for distribution in low- and middle-income countries where 99% of children with HIV in the developing world live,” it said.

MPP has published the full licensing agreement, available at http://www.medicinespatentpool.org/current-licences/.

The MPP-AbbVie agreement covers 102 countries of which more than 65 are classified as middle-income nations, it said. “Provisions in the agreement permit manufacture and distribution in countries where AbbVie does not hold patents, such as in India where the company has withdrawn its patent applications for both lopinavir and ritonavir,” MPP said.

The deal is significant for several reasons, MPP Head of Communications Katie Moore told Intellectual Property Watch. It is the first licence AbbVie has ever issued for these medicines. It is a very important medicine for the WHO, but the current form is liquid syrup (with a bad taste) that requires refrigeration. And MPP has the licence, which allows for the development of other LPV/r reformulations.

“Of the 3.2 million children with HIV in the world, more than 90% live in sub-Saharan Africa with South Africa bearing a significantly high burden,” South African Minister of Health Aaron Mostoaledi was quoted as saying. “New adapted treatments of LPV/r and other medicines are urgently needed to end the HIV paediatric crisis.”

“This is a crucial licence for paediatric programmes in resource-limited countries,” MPP Executive Director Greg Perry, said in a release. “LPV/r in its current form is not suitable for those most vulnerable, infants and toddlers living with HIV. Now, MPP and its partners have the green light to speed the development and distribution of new formulations for young children, the vast majority of whom have no access to HIV therapy.” LPV/r-based regimens are now the WHO-preferred option for first-line treatment in children less than three years of age and second-line for older children, MPP said.

The agreement fits within the Paediatric HIV Treatment Initiative (PHTI), a collaboration of UNITAID, MPP, the Drugs for Neglected Diseases initiative (DNDi), and the Clinton Health Access Initiative (CHAI). MPP, founded in 2010, is backed by UNITAID.

To date, MPP has signed agreements for eleven antiretrovirals (ARVs) and for one medicine for an HIV opportunistic infection. Ten generic manufacturers have now licensed from the organisation.

New WHO Guidelines on HIV

Separately, the WHO today issued new recommendations to help countries close important gaps in HIV prevention and treatment services.

“The guidelines include advice on providing antiretroviral drugs for people who have been exposed to HIV – such as health workers, sex-workers, and survivors of rape – what is often described as ‘post-exposure prophylaxis’, or PEP,” WHO said. “They also include recommendations on preventing and managing common “opportunistic infections” and diseases such as severe bacterial and malaria infections.”

The guidelines are published here [pdf].

Image Credits: WHO