Gilead Sciences, Inc. (Nasdaq: GILD), together with Mylan Laboratories, Ranbaxy Laboratories Limited and Strides Arcolab, announced today that they 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. Under the new agreements 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.
World Health Organization guidelines recommend emtricitabine, as well as tenofovir disoproxil fumarate (TDF), as preferred components of first- and second-line HIV therapy. However, cost is currently a barrier to broadening access to regimens that include emtricitabine when compared to other regimens, 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.
“More than 2.7 million patients living with HIV in developing countries are currently receiving a TDF-containing regimen, a medicine innovated by Gilead and subsequently licensed to our Indian generic partners as part of our efforts to increase global access to effective treatment. India’s pharmaceutical industry is a world leader in process chemistry, and our ongoing collaboration will be critical for furthering access to affordable, high-quality, first-line HIV treatment for developing countries,” said John C. Martin, PhD, Gilead’s Chairman and Chief Executive Officer.
Heather Bresch, Chief Executive Officer of Mylan Inc., commented: “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, and once again we are delighted to be collaborating with Gilead in these efforts. Partnerships like this one ensure that patients in developing markets have access to important, recommended treatment options, like emtricitabine.”