Pharmaceutical companies Gilead Sciences, Mylan Laboratories, Ranbaxy Laboratories and Strides Arcolab have entered into agreements to collaborate on promoting access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine (FTC) in developing countries, including single tablet regimens containing emtricitabine and fixed-dose combinations of emtricitabine co-formulated with other Gilead HIV medicines.
Gilead will provide a technology transfer for the manufacture of emtricitabine, together with funding to assist with investment in process improvements to reduce overall manufacturing costs.
Currently, cost is a barrier to broadening access to regimens that include emtricitabine when compared to other HIV therapies, including widely used lamivudine (3TC)-based regimens. The new agreements are designed to enable Gilead's Indian generic partners to produce high volumes of FTC/TDF-based therapies, thereby establishing sustainable price parity to these alternative regimens.
“An essential component of ensuring access to affordable health care around the world is providing access to high-quality, cost-effective medications. Access to affordable medicine continues to be a particularly acute need in tackling HIV/AIDS,” said Heather Bresch, CEO of Mylan. “Partnerships like this one ensure that patients in developing markets have access to important, recommended treatment options, like emtricitabine.”
Emtricitabine is marketed by Gilead under the brand name Emtriva, and a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate is made available under the brand name Truvada. Emtricitabine is also an essential component of the Quad, an investigational treatment that combines four Gilead medicines in a once-daily, single tablet regimen for the treatment of HIV.