12 DECEMBER 2013, GENEVA: The Medicines Patent Pool (MPP) and biopharmaceutical company Bristol-Myers Squibb have signed a licensing agreement to increase access to a key HIV medicine, atazanavir, in 110 developing countries. These countries represent 88.5 percent of people living with HIV/AIDS in developing countries.
“This agreement 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. Together with Bristol-Myers Squibb, we will be expanding access to an important HIV medicine,” said Greg Perry, Executive Director of the Medicines Patent Pool.
This is the MPP’s first agreement covering a World Health Organization (WHO)-preferred second-line therapy. The WHO estimates there will be over 1 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, Director General, WHO. “I welcome this move to help ensure urgently needed medicines are more widely available at affordable prices.”
The MPP has focused its negotiations on WHO recommended medicines to ensure more affordable access to HIV treatment in places where it is critically needed. Previous agreements with Gilead Sciences and ViiV Healthcare [a joint venture of GlaxoSmithKline, Pfizer, and Shionogi] have expanded access to WHO-preferred first-line treatments for adults and children.
Under the terms of 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 that are collected under this licence agreement will be reinvested in local HIV/AIDS groups in those countries.
“Bristol-Myers Squibb has a legacy of working collaboratively with the HIV/AIDS community to help meet the diverse needs of patients living with this disease – from developing innovative medicines to supporting disease education efforts to ongoing clinical research,” said Dr. Douglas Manion, Senior Vice President, Development, Virology and Japan, Bristol-Myers Squibb. “Our collaboration with MPP builds on this legacy and reflects our commitment to help increase access to atazanavir for HIV patients in the developing world.”
NOTES TO THE EDITOR
Global Impact of HIV
UNAIDS estimates that there are 35.3 million people living with HIV, and that 28.6 million people are now eligible for antiretroviral therapy. As a result of recent advances in access to antiretroviral therapy (ART), HIV-positive people now live longer and healthier lives. At the end of 2012, close to 10 million people were receiving ART in low- and middle-income countries. However, almost 19 million other people who are eligible for ART under the WHO 2013 guidelines did not have access to antiretroviral drugs. Second-line treatments are needed for people living with HIV where first-line antiretrovirals are no longer effective.
There will be over 1 million people on second-line HIV treatment by 2016, and many more will need access to second-line medicines. According to 2013 WHO treatment guidelines, boosted atazanavir is a preferred PI (protease inhibitor) option for a second line anti-retroviral therapy and can be taken once-daily.
About the Medicines Patent Pool
The Medicines Patent Pool is a United Nations backed organisation offering a public-health driven business model that aims to lower the prices of HIV medicines and facilitate the development of better-adapted HIV medicines, such as simplified “fixed-dose combinations” and special formulations for children. It was founded in 2010 at the request of the international community through the World Health Organization-based financing mechanism UNITAID. It works by creating a pool of relevant patents for licensing to generic manufacturers and other producers, facilitating the generic competition that brings down prices and can help stimulate innovation. The Medicines Patent Pool has been endorsed by the World Health Organization, the UN High Level Meeting on AIDS, and the Group of 8 as a promising innovative approach to improve access to HIV medicines.
As with all MPP licences, the full text of this agreement is available on the MPP website at http://www.medicinespatentpool.org/licensing/current-licences/.
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