Ranbaxy, Gilead sign licensing agreement

New Delhi: Ranbaxy Laboratories has entered into an in-licensing agreement with Gilead Sciences to promote 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 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 will, therefore, enable Ranbaxy to produce high volumes of FTC/TDF based therapies, thereby establishing sustainable price parity to alternative regimens.

Commenting on the agreement, Mr Arun Sawhney, CEO & MD, Ranbaxy, said, "Ranbaxy and Gilead have a strong collaboration going 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 the developing 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 which combines four Gilead medicines in a once-daily, single tablet regimen for the treatment of HIV.