03 August 2012 | News | By BioSpectrum Bureau
Mylan to produce generic of Gilead's HIV drug
Mylan will produce generic version of Gilead's HIV drug
Singapore: Mylan signed a new agreement between its subsidiary Mylan Laboratories and Gilead Sciences. According top this agreement, Mylan licensed the rights to produce and market generic versions of Gilead HIV/AIDS therapies containing Emtricitabine, including single and fixed-dose combinations.
Emtricitabine is marketed by Gilead under the brand name Emtriva, and a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate is available under the brand name Truvada. Emtricitabine also is a component of the Quad, an investigational medicine that combines four Gilead medicines in a once-daily, single tablet regimen for the treatment of HIV-1 infection.
Mr Heather Bresch, CEO, Mylan, said that, "Access to affordable medicine continues to be an acute need in tackling HIV/AIDS, and once again we are delighted to be collaborating with Gilead in these efforts. Mylan is focused on expanding access to high-quality treatments to those in need around the world. Partnerships like this one ensure that patients in developing markets have access to important, recommended treatment options, like those containing emtricitabine."
Under previously-signed licensing agreements with Gilead, Mylan Laboratories obtained licensing rights to several Gilead products, which are currently in late-stage clinical development, including Elvitegravir, an investigational integrase inhibitor; Cobicistat, an investigational boosting agent to increase blood levels and allow once-daily dosing for certain HIV medicines; and the Quad.
Additionally, Mylan Laboratories obtained non-exclusive rights to produce and market active pharmaceutical ingredients and finished products, including generic versions of Viread (Tenofovir Disoproxil Fumarate or TDF), Truvada (Emtricitabine/Tenofovir Disoproxil Fumarate) and other TDF-based combinations in over 100 developing countries including India.