The Medicines Patent Pool on Janssen’s Extension of its Access Policy for Paediatric Medicine Darunavir
11 May 2015
The MPP welcomes Janssen’s announcement today extending its access policy for paediatric formulations of darunavir in support of the Paediatric HIV Treatment Initiative (PHTI). The company’s new policy to waive enforcement of any patent rights for paediatric formulations of darunavir in additional countries, along with its commitment to providing technical expertise to the PHTI, complements the actions of other companies that have signed MPP licence agreements to improve HIV paediatric care.
The PHTI, a collaboration among MPP, UNITAID, the Drugs for Neglected Diseases initiative (DNDi) and the Clinton Health Access Initiative (CHAI) was launched last May to speed the development of better-adapted HIV medicines for children living in resource-limited countries. PHTI partners are currently working with industry, pharmacokinetic experts, regulators, the WHO and others on projects for the development of WHO “missing formulations” to meet new treatment guidelines for children and have kicked off development plans for both abacavir/lamivudine/efavirenz (ABC/3TC/EFV) and for darunavir boosted with ritonavir (DRV/r).
The WHO has identified DRV/r as an urgently needed combination for “robust second-line alternatives”and thus the MPP has been working with Janssen to facilitate DRV/r development by the PHTI. AbbVie has granted the MPP a licence for ritonavir allowing generic manufacturers to reformulate and combine the antiretroviral with other paediatric medicines, for example, darunavir, for developing optimized paediatric formulations. Janssen’s participation on the PHTI DRV/r project team is crucial to the success of DRV/r development and distribution.
Developing high-priority fixed-dose combinations (FDCs) for children with HIV is a public health priority. While the world has made significant progress in scaling up HIV treatment programmes for adults, only a quarter of children living with the virus receive therapy. A lack of child-friendly treatments appropriate across all ages and weight-bands contributes to low coverage rates. To date, MPP has signed paediatric licences with AbbVie, Bristol-Myers Squibb, Gilead, MSD and ViiV Healthcare to narrow the treatment gap for the 3.2 million children now living with HIV globally.
 World Health Organization March 2014 Supplement: On the use of antiretroviral drugs for treating and preventing HIV infection.