In a strategic move aimed at ensuring availability of affordable HIV drugs to patients across the developing countries, the Medicines Patent Pool (MPP), a United Nations-backed organisation founded by UNITAID entered into first agreement with a Chinese manufacturer Desano; and with India based Cipla, Mylan and Micro Labs, while also extending collaborations with Aurobindo, Laurus Labs and Emcure for the manufacture generic HIV medicines, atazanavir (ATV) and dolutegravir (DTG).
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. 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.
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.
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, a global pharmaceutical company with a strong presence in the HIV field and Mylan, a global generics and specialty pharmaceutical 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. 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,” informed Dr Jaideep Gogtay, chief medical officer of Cipla.