Bristol-Myers Squibb and Gilead plan to submit an NDA in the second quarter for a fixed-dose combination of Bristol's Sustiva (efavirenz) and Gilead's Truvada (emtricitabine/tenofovir disoproxil).

The firms announced Jan. 9 that they had acquired data supporting bioequivalence of the three-drug HIV therapy. The firms had failed to demonstrate bioequivalence with two prior formulations of the HIV therapy. In August, Gilead announced that the firms would reformulate the combination using a bi-layer technology.

The bi-layer technology unites Sustiva and Truvada as "individually formulated layers combined in one tablet," the firms said.

Bristol and Gilead established a joint venture to develop the Sustiva/Truvada combo at the end of 2004 (¹ Also see "Bristol/Gilead Joint Venture Targets 2005 Filing For HIV Fixed-Dose Combo" - Pink Sheet, 20 December, 2004.).

If approved, "the new product would be the first complete highly active antiretroviral therapy treatment regimen for HIV available in a fixed-dose combination tablet taken once daily," the firms said.

An April 2005 FDA draft guidance on user fees for HIV drugs explained that most fixed-dose combinations of HIV therapies would not be charged user fees under the President's Emergency Plan for AIDS Relief and could receive expedited reviews.

According to the firms, guidelines "list the combination of emtricitabine, tenofovir disoproxil fumarate and efavirenz as one of the preferred non-nucleoside reverse transcriptase inhibitor-based treatments for use in appropriate patients that have never taken anti-HIV medicines before."

Truvada was approved in August 2004, although its component drugs (Gilead's Emtriva and Viread ) have been available since 2003 and 2001, respectively. Sustiva was first approved in 1998.

-Kathleen Michael

Bristol/Gilead HIV Combo Will Go To FDA In Mid-2006

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