The Medicines Patent Pool (MPP) has announced new manufacturing licences for a generic copy of Bristol-Myers Squibb's (BMS, US) Daklinza (daclatasvir) tablets for treating hepatitis C virus (HCV).
Implications | MPP has signed licences with India-headquartered Aurobindo, Cipla, Emcure, Hetero Labs, Laurus Labs, and Zydus Cadila and China-based Desano for a total of nine new sub-licensing agreements to produce generic versions of key World Health Organization-priority HIV and hepatitis C treatments. |
Outlook | These new sub-licences will secure greater volumes of low-cost medicines for people living with HIV and hepatitis C in low- and middle-income countries. |
The Medicines Patent Pool (MPP) has announced new manufacturing licences for a generic copy of Bristol-Myers Squibb's (BMS, US) Daklinza (daclatasvir) tablets for the treatment of hepatitis C virus (HCV). MPP has signed licences with India-headquartered Aurobindo, Cipla, Emcure, Hetero Labs, Laurus Labs, and Zydus Cadila and China-based Desano for a total of nine new sub-licensing agreements to produce generic versions of key World Health Organization (WHO)-priority HIV and hepatitis C treatments.
MPP's long-time generic partner Aurobindo signed two new sub-licences. The first allows the company to produce lopinavir and ritonavir for Africa, following MPP's agreement with AbbVie (US) in December 2015. Aurobindo also joins six other companies in the development for daclatasvir, the first hepatitis C medicine in MPP's portfolio. Meanwhile, Desano, a Chinese manufacturer based in Shanghai, and Emcure also signed licences for lopinavir and ritonavir.
Hetero, an MPP generic partner since 2012, signed sub-licences for atazanavir, an important second-line antiretroviral licensed to the MPP by BMS in December 2013, and raltegravir for paediatric use, a treatment MPP licensed from MSD (Merck & Co. in the United States and Canada) in February 2015. Raltegravir was recently recommended by the WHO as part of second-line treatment for children under 10.
Laurus and Lupin added to their portfolio of MPP-licensed drugs with agreements to produce daclatasvir and paediatric raltegravir, respectively.
The Zydus group has recently joined MPP's growing network of generic suppliers with a sub-licence for daclatasvir as well (see India: 8 July 2016: Zydus Cadila signs agreement on HCV drug with Medicines Patent Pool).
Outlook and implications
The MPP is a public health organisation funded by the United Nations and dedicated to improving access to treatments for HIV, viral hepatitis, malaria, and tuberculosis for patients in low-income countries.
These new sub-licences will secure greater volumes of low-cost medicines for people living with HIV and hepatitis C in low- and middle-income countries. The MPP's 13 generic manufacturing partners are currently working on more than 60 projects to develop crucial treatments for both children and adults in the developing world.
The inclusion of Daklinza is somewhat rare given that the drug is still in development. Current drugs in the pool are generally established HIV and hepatitis C therapies. Despite the MPP's potential for increasing access to some medicines, activists have argued that, as companies can specify which countries the drugs are licensed for, patients in middle-income countries, normally excluded from licences, may continue to face challenges accessing these drugs (see World - United States: 25 July 2014: Gilead licenses tenofovir alafenamide to Medicines Patent Pool and World - United States - India: 26 September 2014: Medicines Patent Pool licenses Gilead's TAF to five Indian companies in 112 markets).