Before the start of the 20th International AIDS Conference in Melbourne, Australia, the Medicines Patent Pool (MPP) announced seven new sub-licensing agreements for the manufacture of generic HIV medicines, atazanavir (ATV) and dolutegravir (DTG). The United Nations-backed MPP negotiates licences with key patent holders to speed access of low-cost, generic medicines to developing countries. To date, the MPP has signed agreements with Bristol Myers-Squibb, Gilead Sciences, F Hoffmann-La Roche, the US National Institutes of Health and ViiV Healthcare for eight antiretrovirals (ARVs) and one medicine for an HIV opportunistic infection.
“With licences signed, four new manufacturers are joining us to speed the availability of crucial medicines, ATV and DTG, to developing countries. This almost doubles our network of generic partners to ten companies,” said Greg Perry, Executive Director, MPP. “Increased generic competition will ultimately bring prices down and increase availability to allow national treatment programmes to treat many more people in their countries.”
Following its December agreement with Bristol-Myers Squibb for a licence on atazanavir, a WHO-preferred second-line therapy, MPP has signed its first sub-licence with a Chinese generic firm, Desano, a supplier of active pharmaceutical ingredients (API) based in Shanghai, and with Aurobindo and Emcure, key manufacturers of generic antiretroviral medicines, for the production of low-cost atazanavir. Increasing access of second-line treatments for HIV is crucial as more people living with HIV develop resistance to first-line regimens. The WHO estimates there will be more than one million people on second-line treatment by 2016 and many more will need access to these new medicines.
“Aurobindo, a long-time MPP partner, is pleased to help ensure the timely introduction of generic ATV in developing countries,” said Arvind Vasudeva, Chief Executive Officer, Formulations at Aurobindo. “This medicine offers new options for people living with HIV who are no longer able to take their first HIV regimens and its distribution in resource-poor settings is crucial.”
Three months after MPP signed ground-breaking agreements with ViiV Healthcare on new antiretroviral dolutegravir, the organisation has signed four sub-licences for the manufacture of generic versions of the product for both adult and paediatric care. Laurus Labs, granted an MPP licence to produce five Gilead ARVs in 2012, has been granted a new licence for DTG. Micro Labs, a producer of generics including WHO pre-qualified ARVs, Cipla and Mylan, a global generics and speciality pharma company, have become new MPP sublicensing partners.
“The HIV field needs new drugs all the time due to the development of resistance and treatment failure,” said Dr Jaideep Gogtay, Chief Medical Officer of Cipla. “Dolutegravir belongs to the new class of drugs – integrase inhibitors. This class of drugs brings new options for patients, has advantages over the existing drugs in terms of high efficacy and also brings down the viral loads rapidly. Access to the medicine in developing countries will make a major difference to the lives of HIV/AIDS patients living there.”
“Mylan is an established leader in ARVs with a global portfolio of 43 high-quality products. In continuation of our commitment to providing access to a comprehensive range of high-quality, affordable ARV medicines, Mylan is pleased to work with MPP in sub-licensing a new molecule Dolutegravir (DTG),” said Rajiv Malik, President, Mylan.
“The new sub-licensing agreements for generic DTG are a welcome development in ensuring that we reach developing countries with a promising new ARV in record time,” said NK Kothari, Executive Director, Micro Labs. “We hope to have a generic product available as soon as possible to strengthen HIV treatment options in hundreds of countries throughout Africa, Asia and Latin America.”
EP News Bureau- Mumbai