The Medicines Patent Pool (MPP) announced new generic manufacturing licences for four antiretrovirals and hepatitis C direct-acting antiviral daclatasvir. The organisation signed licences with Aurobindo, Desano, Emcure, Hetero Labs, Laurus Labs, Lupin and new partner Zydus Cadila for a total of nine new sub-licensing agreements to produce generic versions of key World Health Organization-priority HIV and hepatitis C treatments.
"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," said Greg Perry, MPP's executive director. "We look forward to working with the companies to speed delivery of these treatments to those most in need of better medical options."
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 in December 2015. Aurobindo also joins six other companies in the development of Bristol-Myers Squibb (BMS)'s daclatasvir, the first hepatitis C medicine in MPP's portfolio. "We are very pleased to support product development of these key medicines for both HIV and hepatitis C and to continue our work with the MPP to bring formulations and fixed-dose combinations to market very soon," said Aurbindo's managing director N. Govindarajan.
Desano, a Chinese manufacturer based in Shanghai, and Emcure also signed licences for lopinavir and ritonavir. "Desano welcomes the opportunity of supporting increased volumes of this crucial treatment for people living with HIV/AIDS in Africa, and specifically for South Africa, which has the largest HIV treatment programme in the world," said Tun Guo, director and company secretary. Vik Thapar, head of strategy, Emcure added, "LPV/r is a life-line for people living with HIV on the continent who have developed resistance to first-line treatments. Additional, long-term supply is crucial."
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 less than 10 years of age. "Hetero, through its partnership with MPP, has demonstrated success in creating larger access for HIV and hepatitis C treatment and now looks forward to supporting efforts to distribute low-cost versions of atazanavir and raltegravir," said Bhavesh Shah, director- Hetero Drugs Limited.
Laurus and Lupin added to their portfolio of MPP-licensed drugs with agreements to produce daclatasvir and paediatric raltegravir, respectively. "Laurus has been working with the MPP for more than four years on HIV and we are happy to support efforts to successfully treat hepatitis C with this promising medicine," stated Raju Kalidindi executive director. "Lupin welcomes its fourth sub-licence with the MPP and to collaborating with the organisation on development plans for raltegravir," said Naresh Gupta, president -API Plus.
The Zydus group, based in Ahmedabad, India and a specialist in developing hepatitis B and C products has now joined MPP's growing network of generic suppliers with a sub-licence for daclatasvir as well. "We are happy to work together with the MPP and BMS to improve health outcomes by providing access to new and affordable therapies to developing countries," said Pankaj R. Patel, chairman and managing director of the Zydus group.
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 developing world settings.
The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with six patent holders for twelve HIV antiretrovirals and for one hepatitis C direct-acting antiviral. Its generic partners have distributed more than three billion doses of low-cost medicines to 121 countries. The MPP was founded and remains fully funded by UNITAID.