A 2004 joint venture between Gilead Sciences Inc. and Bristol-Myers Squibb Co. has led to the approval of the first once-daily, triple-drug regimen for HIV-1 patients.
The FDA gave the nod to Atripla, which combines Foster City, Calif.-based Gilead's Truvada, a fixed-dose product comprising Viread (tenofovir disoproxil) and Emtriva (emtricitabine), with New York-based BMS' Sustiva (efavirenz).
All three ingredients work by blocking reverse transcriptase, an enzyme needed for HIV replication.
Atripla, which can be administered as a stand-alone therapy or in combination with other antiretrovirals, is expected to be available in the U.S. within the next seven business days.
Gilead's stock (NASDAQ:GILD) gained 3 cents Wednesday to close at $61.79.
The companies signed a joint venture in December 2004 to simplify the daily regimen for adult HIV patients by combining Truvada and Sustiva into a single, daily tablet. Under the terms, both companies agreed to fund development work and will receive revenues based on the percentages of each product's contribution to the final drug formulation. (See BioWorld Today, Dec. 21, 2004.)
The finished product is made up of 600 mg of Sustiva, plus Truvada (200 mg of Emtriva and 300 mg of Viread).
Truvada, which gained FDA approval in August 2004, posted sales of $248.9 million for the first quarter.
Forty-eight week data from an ongoing study comparing Atripla with twice-daily Combivir (lamivudine/zidovudine, GlaxoSmithKline plc) in combination with Sustiva, showed that 84 percent of patients in the Atripla arm achieved and maintained HIV-1 RNA less than 400 copies/mL, compared to 73 percent in the Combivir/Sustiva arm.
The difference largely was attributed to the higher number of patients who discontinued treatment in the Combivir/Sustiva group due to adverse events, non-compliance and protocol violation.
Gilead reported net income of $262.7 million, or 55 cents per share, for the first quarter. As of March 31, it had cash, cash equivalents and marketable securities of $2.5 billion.
In its development pipeline, Gilead is testing GS 9137, an integrase inhibitor licensed last year from Japan Tobacco, of Tokyo, in Phase II HIV studies, and has two ongoing pivotal trials of Viread in chronic hepatitis B.