The Burrill Report

The U.S. Food and Drug Administration has approved Gilead Sciences’ Stribild, previously known as Quad, a once-daily pill for adults with HIV-1 infection who have not been previously treated with HIV medications. The approval extends Gilead’s market-leading antiviral treatment franchise.

“Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” says Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “New combination HIV drugs like Stribild help simplify treatment regimens.”

The new pill combines two previously approved compounds, emtricitabine and tenofovir disoproxil fumarate—marketed by Gilead as Truvada—with two newly approved compounds, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat is a pharmacokinetic enhancer, inhibiting an enzyme that metabolizes certain HIV drugs and is used to prolong the effect of elvitegravir. Truvada, approved in 2004, blocks the action of another enzyme that HIV needs to replicate in a person’s body.

About 1.2 million people are infected with the HIV virus in the United States, according to the Centers for Disease Control. There are about 50,000 new infections each year. Stribild, the third HIV drug Gilead has brought to market, is expected to be a potential blockbuster and strong growth driver for the California-based biopharma.

At a cost of about $28,500 a year, the drug has also drawn criticism from activist groups and government leaders who contend it will put pressure on public health systems already strained by the high cost of healthcare.

Stribild is expected to be a profit center for Gilead. While its combination therapies Atripla and Complera contain active ingredients developed by others, Bristol-Myers Squibb in the case of Atripla and Johnson & Johnson in the case of Complera, Gilead owns all four active ingredients in Stribild. Sales of the drug are expected to be about $462 million in 2013 and reach $2.8 billion by 2013, according to EvaluatePharma, surpassed only by the sales potential of Gilead’s late-stage hepatitis C therapy GS-7977, which was acquired with its $11 billion acquisition of Pharmasset last year.

Approval of Stribild was expected after a strong vote for approval by an advisory committee that was based on two late stage trials that showed the effectiveness of Stribild equal to Atripla or a combination of Truvada plus atazanavir and ritonavir, but with a slightly better safety profile. Like the labels of many other drugs used to treat HIV, Stribild’s label will carry a boxed warning alerting patients and physicians that the drug can cause a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal. The label also warns that the drug cannot be prescribed to treat chronic hepatitis B infection, according to a statement by the FDA.


August 30, 2012
http://www.burrillreport.com/article-fda_approves_gilead%e2%80%99s_4_in_1_hiv_pill_.html