Three Indian companies to benefit from UN arm’s generics pact

17 Jul 2014

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The United Nations-backed Medicines Patent Pool has announced seven new sub-licensing agreements for the manufacture of generic HIV medicines, atazanavir (ATV) and dolutegravir (DTG) with companies including India-based Cipla, Aurobindo and Emcure.

The announcement comes three days ahead of the start of the 20th International AIDS Conference in Melbourne, Australia.

The Medicines Patent Pool (MPP) and ViiV Healthcare had, on 1 April 2014, announced the signing of two licensing agreements to increase access to dolutegravir (DTG), a promising new antiretroviral, for both adult and paediatric care.

ViiV Healthcare is a global specialist HIV company dedicated to delivering advances in treatment and care for people living with HIV.

The MPP had earlier, on 12 December 2013, signed an agreement with biopharmaceutical company Bristol-Myers Squibb to increase access to a key HIV medicine, atazanavir, in 110 developing countries. These countries represent 88.5 per cent of people living with HIV/AIDS in developing countries.

The MPP had, on 5 August 2013, announced an agreement with Swiss pharmaceutical company Roche to increase access to valganciclovir, a key easy-to-take oral medicine to treat cytomegalovirus (CMV), a viral infection that can cause blindness in people living with HIV.

This agreement is unique in being a two-phased approach to better treat the infection. First, an agreement that will significantly improve access to Roche's valganciclovir for people living with HIV in 138 developing countries by making it up to 90-per cent cheaper than current prices.

As a second step, the Medicines Patent Pool and Roche will enter into licensing and technology transfer negotiations to encourage the development of internationally approved quality generic versions of valganciclovir.

The Medicines Patent Pool, on 27 February 2013, announced a collaboration with ViiV Healthcare under which ViiV Healthcare had committed to license its pipeline products for paediatric use in 118 countries once they are approved by drug regulatory authorities; provide technology transfer to aid in generic manufacture; access to data on medicines quality and efficacy; and planned partnerships with third-party stakeholders to help bring to market as-yet undeveloped new treatments, and to speed the availability of those treatments in developing countries.

Since its signing, the agreement has been amended four times. The Medicines Patent Pool received its first licences from the US National Institutes of Health for patents related to the HIV medicine darunavir in September 2010.

The Medicines Patent Pool (MPP) was created to increase access to quality, appropriate, affordable medicines for people living with HIV in developing countries.

The MPP's offers a public-health driven business model that facilitates the production of low-cost versions of existing medicines as well as the development of needed new formulations, such as ''fixed-dose combinations'' – one pill comprised of several medicines that increase treatment adherence – and formulations suitable for children.

It does this through voluntary licensing of key HIV medicines patents.

The MPP was formed at the request of the international community in 2010 through innovative financing mechanism UNITAID. It has been endorsed by the World Health Organization, the UN High Level Meeting on AIDS, and the Group of 8 as a promising approach to improve access to HIV medicines.

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