 "Cipla, Mylan, Micro Labs, Aurobindo, Emcure ink licensing pact for antiretrovirals with a UN unit")
Medicines Patent Pool (MPP), a United Nations-backed organisation founded to increase access to HIV treatment and spur new innovation worldwide, has signed new sub-licensing agreements for the manufacture of generic HIV medicines, atazanavir (ATV) and dolutegravir (DTG), with seven companies – of which six are from India. Indian companies who will supply generics to Medicines Patent Pool include Cipla, Mylan, Micro Labs, Aurobindo, Laurus Labs and Emcure.
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 today, 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. Increased generic competition will ultimately bring prices down and increase availability to allow national treatment programmes to treat many more people in their countries,” said Greg Perry, Executive Director, MPP.
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.
“Aurobindo, a long-time MPP partner, is pleased to help ensure the timely introduction of generic ATV in developing countries. 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,” said Arvind Vasudeva, Chief Executive Officer, Formulations at Aurobindo.
Three months after Medicines Patent Pool 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, Cipla and Mylan have become new MPP sublicensing partners.
Dr Jaideep Gogtay, Chief Medical Officer of Cipla, said, “The HIV field needs new drugs all the time due to the development of resistance and treatment failure. 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.”
Rajiv Malik, President, Mylan, stated, “Mylan is pleased to work with MPP in sub-licensing a new molecule Dolutegravir (DTG). DTG represents a significant advancement in HIV treatment as it does not require boosting when combined with other appropriate ARVs and has a good efficacy profile at very small doses. This addition further strengthens our portfolio of HIV/AIDS products and helps us deliver on our mission to provide the world's seven billion people with access to high quality medicine.”
“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. 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,” added N K Kothari, Executive Director, Micro Labs.
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 today, 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. Increased generic competition will ultimately bring prices down and increase availability to allow national treatment programmes to treat many more people in their countries,” said Greg Perry, Executive Director, MPP.
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.
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“Aurobindo, a long-time MPP partner, is pleased to help ensure the timely introduction of generic ATV in developing countries. 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,” said Arvind Vasudeva, Chief Executive Officer, Formulations at Aurobindo.
Three months after Medicines Patent Pool 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, Cipla and Mylan have become new MPP sublicensing partners.
Dr Jaideep Gogtay, Chief Medical Officer of Cipla, said, “The HIV field needs new drugs all the time due to the development of resistance and treatment failure. 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.”
Rajiv Malik, President, Mylan, stated, “Mylan is pleased to work with MPP in sub-licensing a new molecule Dolutegravir (DTG). DTG represents a significant advancement in HIV treatment as it does not require boosting when combined with other appropriate ARVs and has a good efficacy profile at very small doses. This addition further strengthens our portfolio of HIV/AIDS products and helps us deliver on our mission to provide the world's seven billion people with access to high quality medicine.”
“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. 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,” added N K Kothari, Executive Director, Micro Labs.