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Gilead Quad Pill Can Overtake Atripla, Milligan Says
February 09, 2010,
Feb. 9 (Bloomberg) -- Gilead Sciences Inc., the world's biggest maker of AIDS medicines, will begin three final-stage tests in 2010 for a four-drug combination pill against HIV that has the potential to generate $4 billion a year.
The "quad" can overtake sales of Atripla, Gilead's three- drug pill, Chief Operating Officer John Milligan said today in an interview. "If patients are already on Atripla and they want to switch because they have side effects, this would be a good substitution," Milligan said.
Gilead said last month that the quad pill, which combines two of its established drugs with two experimental treatments, worked at least as well as Atripla. If the quad is safer, Gilead shares may rise to the low $50s, said Joshua Schimmer, with Leerink Swann & Co. in New York, in a Feb. 4 interview. It can generate $4 billion a year by 2014, said Geoffrey Porges, an analyst at Sanford C. Bernstein & Co.
"The quad pill has the potential to extend the lifespan of the company's leading HIV franchise materially," Porges said in a Jan. 6 research note. The new therapy can also "significantly increase their HIV franchise profitability through higher pricing and lower costs of goods versus Atripla."
Without Bristol-Myers
Gilead, based in Foster City, California, had sales of $2.4 billion last year from Atripla, a drug sold with Bristol-Myers Squibb Co. The quad, made without Bristol-Myers ingredients, will help replenish revenue after three AIDS therapies responsible for 80 percent of sales face generic competition from 2017 and 2021.
"The thing that investors are scared to death of is what happens after the patents expire," said Philip Nadeau, an analyst at Cowen & Co. in New York, in a telephone interview. "The quad is a great way for Gilead to extend its dominance."
Gilead will present quad pill results, from the second of three stages of tests generally needed for U.S. approval, at the Conference on Retroviruses and Opportunistic Infections starting Feb. 16 in San Francisco.
Gilead rose 11 cents to $46.20 at 11:22 a.m. New York time in Nasdaq Stock Market composite trading, after falling 11 percent in the 12 months before today.
85 Percent of Patients
About 1.1 million Americans live with HIV, according to the U.S. Centers for Disease Control and Prevention. Gilead's pills are taken by 85 percent of patients as a first defense against the virus.
Atripla contains Truvada, Gilead's two-drug combination, and Bristol-Myers's Sustiva. The Bristol-Myers drug can cause nervous system side effects -- bad dreams, hallucinations, dizziness -- in more than half of patients, according to the medicine's prescribing information. The quad pill cuts out the Bristol component and is designed to avoid the side effects, as well as costs, of including Sustiva. Gilead's quad pill combines the two ingredients of Truvada with two experimental compounds. One of the new compounds, elvitegravir, blocks the enzyme integrase, which the virus needs to replicate. The other, an experimental booster drug called GS-9350, increases the effect of the inhibitor to allow once-daily dosing.
Multiple Treatments
People with the human immunodeficiency virus, or HIV, take drugs every day to suppress the virus to levels that are undetectable by a blood test. HIV adapts quickly to sidestep individual medicines, and multiple treatments are given simultaneously to create a wall of protection. No combination can block the virus permanently, and new medications must be given when the virus re-emerges.
In initial results of the quad pill study, 71 HIV-infected patients who hadn't been treated previously with antiretroviral medicines took either Atripla or the quad pill, Gilead said in a Jan. 6 statement. Halfway into the planned 48-week study, the patients in both groups had similar reductions in their viral levels, the company said.
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