Gilead Sciences, Inc., together with Mylan Laboratories, Ranbaxy Laboratories Limited and Strides Arcolab, have announced 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.”
Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy Laboratories Limited, commented: “Ranbaxy and Gilead have a strong collaboration in the area of HIV/AIDS. We are pleased to extend this association with Gilead that will enable us to offer quality affordable medicines for the treatment of HIV/AIDS in developing countries.”
Arun Kumar, Managing Director and Group Vice-Chairman, Strides Arcolab Ltd., commented: “We are pleased to associate with Gilead on this initiative that will provide access to high quality essential antiretrovirals in developing markets. This partnership will re-enforce our commitment to provide affordable drugs in the field of HIV/AIDS, tuberculosis and malaria to low- and middle-income countries.”
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.
Enabling Affordable Access to HIV Medicines in Developing Countries
Gilead has a longstanding commitment to make its antiretroviral products available at significantly reduced prices in developing countries.
A key component of this commitment is non-exclusive generic licensing agreements established with Indian manufacturers to produce and sell high-quality, low-cost versions of Gilead’s HIV medicines. A total of 13 Indian companies now have licensed Gilead HIV medicines.
Mylan Laboratories (formerly Matrix), Ranbaxy Laboratories and Strides Arcolab have had direct licensing partnerships with Gilead since 2006.
Today’s announcement follows an agreement signed in July 2011, to also grant them future rights to elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the Quad. As these are all investigational products, their safety and efficacy have not yet been established.