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ViiV Healthcare announces new initiatives to improve access to dolutegravir through licence to the Medicines Patent Pool

London 4 April 2014 – On April 1, ViiV Healthcare announced a new collaboration designed to increase access to its HIV medicine, dolutegravir (marketed under the name Tivicay®), just two months after its approval by the European Medicines Agency (EMA) and eight months after being approved by the US Food and Drug Administration (FDA). Through an agreement with the Medicines Patent Pool (MPP), ViiV Healthcare will increase access to dolutegravir in the countries where 99% of children and 93.4% of adults with HIV in the developing world live. This timely collaboration represents one of the fastest licences granted to the MPP for a newly approved medicine to date.


“Our new collaborations prioritise dolutegravir access for millions of children and adults with HIV, and represent another step in our ongoing commitment to improving access and delivering innovation in the areas of highest unmet need,” said Dr Dominique Limet, Chief Executive Officer of ViiV Healthcare. “We recognise that important new agents have the potential to make a real difference in resource poor settings. In fact, the World Health Organization has recently cited dolutegravir as a development priority for future anti-retroviral treatments for children–it is currently approved for children 12 years and older.i Therefore, accelerating access to medicines like dolutegravir is of the utmost importance.”

The agreement with MPP will grant the organization – which was founded in 2010 by the innovative financing entity UNITAID – a voluntary licence which will enable generic manufacturers to develop paediatric formulations of dolutegravir without paying a royalty in 121 countries where most (99%) children with HIV live. Dolutegravir is currently approved for patients 12 years and older. However, this licence also includes a commitment for future lower dose tablets and age-appropriate formulations developed by ViiV Healthcare to meet the needs of younger children with HIV, if and when approved by a major regulatory authority.

The collaboration also includes two distinct approaches to improving access for adults living with HIV: first, a royalty-free voluntary licence in all least-developed, all low-income and all sub-Saharan African countries and; second, for specific middle-income countries including India, ViiV Healthcare has established the first-ever MPP licence with a tiered royalty structure, where a small percentage of the sale price is paid based on the gross domestic product (GDP) of the specific country. These licences will also allow for the possible development, manufacture and supply of dolutegravir-based fixed-dose combinations, including those with abacavir, if and when approved by local regulatory agencies.

ViiV Healthcare is committed to developing meaningful partnerships with relevant stakeholders in order to ensure access to this, and other, important medicines and to elevating HIV care and resources in the communities where they are most needed. This announcement complements an earlier voluntary licence for dolutegravir signed in 2013 with Aurobindo Pharma for adults and children for ViiV Healthcare’s standard voluntary licence territories.

References

  1. “MARCH 2014 SUPPLEMENT TO THE 2013 CONSOLIDATED GUIDELINES ON THE USE OF ANTIRETROVIRAL DRUGS FOR TREATING AND PREVENTING HIV INFECTION. Recommendations for a public health approach.” WHO. Web. 28 February 2014. http://www.who.int/hiv/pub/guidelines/arv2013/arvs2013upplement_march2014/en/.

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