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Indian drug makers wanting to make AIDS drug atazanavir, will now be able to do so, following a licensing agreement signed by multinational drug-major Bristol-Myers Squibb and the United Nations-backed Medicines Patent Pool.
BMS’ drug atazanavir is used in the second-line treatment of HIV/AIDS. And the agreement, announced on Thursday, will allow manufacturers world-wide to produce more affordable versions of atazanavir, and to combine atazanavir with other medicines to make treatment easier and more accessible in developing countries, said Greg Perry, Executive Director of the Medicines Patent Pool (MPP).
Generic drug makers, many of whom are in India, will be able to access the technology to make the drug and export it to 110 countries. Over 88 per cent of people living with HIV/AIDS in developing countries are covered by the scope of this agreement, the MPP said.
Generic participation
BMS has existing agreements on this drug with the Pune-based Emcure and the Gurgaon-based Ranbaxy, besides multinationals Mylan and Aspen. But these agreements cover about 50 countries.
The MPP agreement more than doubles the countries covered, and allows for more players to make the drug, said Sandeep Juneja, MPP’s business development director, adding that he would talk to Emcure to join the new agreement.
As more companies participate, the resulting competition will further drive down medicine prices, ultimately benefiting patients, he told Business Line speaking from Geneva.
Citing data from international humanitarian organisation MSF, another MPP representative said BMS’ atazanavir costs about $412 per patient per year, in countries eligible for BMS price discounts. But the price is lower, where generically-similar versions of the medicine are available (sub-Saharan Africa and India) — where the drug costs over $250 per patient per year.
In the past, Indian generic makers, including Aurobindo, Shasun, Laurus, Hetero and Shilpa Medicare, have dipped into the patent pool on various HIV drugs.
Royalty payments
Under the agreement, a technology transfer package will be provided to sub-licensees to facilitate the manufacture of atazanavir. While royalties are not applicable in the vast majority of the countries and are waived for all paediatric products, any royalties collected under this licence agreement will be reinvested in local HIV/AIDS groups in those countries, MPP said.
Generic drug-makers producing chemically-similar versions of BMS’ atazanavir will pay royalties to MPP if they are in markets were patents are granted, Juneja explained. But in India, where the patent application is pending, there will be no royalty till a patent is granted, he added. (Patents allow innovators 20 years of exclusivity to make and sell their innovative product.)
Second-line drug
The MPP agreement is its first on a WHO-preferred second-line therapy. The WHO estimates there will be over one million people on second-line treatment by 2016, and many more will need access to these therapies.
"Second-line treatment is increasingly important as people living with HIV around the world develop resistance to their current regimens," said Margaret Chan, WHO Director-General.
MPP focuses its negotiations on WHO recommended medicines to expand access to HIV treatment. And its previous agreements include those with Gilead Sciences and ViiV Healthcare (a joint venture of GlaxoSmithKline, Pfizer, and Shionogi) to expand access to WHO-preferred first-line treatments for adults and children.
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