IN THE PIPELINE: Gilead Looks To Extend HIV Lead With Drug Combo

Gilead Sciences Inc. (GILD) dominates the HIV treatment market, but it is working to continue that role with a once-a-day pill that contains a four-drug treatment regimen.

The Foster City, Calif., drug maker's $7.4 billion in 2010 product sales mostly came from combination HIV treatments including double-drug Truvada and triple-treatment Atripla, which is the only single-pill full regimen for the disease. The four-drug pill in development, commonly called the Quad, is expected to have late-stage clinical data soon and Gilead plans to file for approval in early 2012.

"It will be nice to have more options for initial therapy with a one-pill-a-day regimen," said Eric Poeschla, an HIV physician and professor at the Mayo Clinic in Rochester, Minn. He has no connections to Gilead.

Having a combination of treatments in one pill is attractive because it ensures that patients take all the drugs they need. Adhering to a prescribed drug regiment is needed to maintain HIV viral suppression. Increased viral load--the amount of virus in the blood--in the presence of medications raises the chances that HIV will mutate and become resistant to the drug.

Last year, UBS estimated that more than 70% of treated patients in the U.S. are using either Atripla or Truvada. A Gilead spokeswoman said Atripla, launched in 2006, "has fast become the most-prescribed HIV treatment in the United States."

Aside from potentially benefiting patients, including possibly cutting back on side effects, the Quad is also financially better for Gilead because it owns all of the components; Atripla includes a Bristol-Myer Squibb Co. (BMY) drug. Also, Wall Street analysts expect the pill to allow for aggressive pricing, something that further enhances the advantages to Gilead's profits.

HIV destroys immune system components called T-cells and the later stage of the disease is called AIDS. The first cases of the disease were diagnosed three decades ago with poor patient prognosis, but antiviral drugs--used in combination to fight resistance--have changed that in the developed world.

"HIV has gone from virtually a uniformly fatal illnes to a very managable condition that is often compared, reasonably, to having diabetes," Dr. Poeschla said. He noted that patients can still have significant medical issues, need to take medicine every day and need to be monitored by a doctor.

The Centers for Disease Control estimates that 1.1 million people in the U.S. were living with HIV infection as of the end of 2006, with 21% of those undiagnosed. In that year, about 56,300 people were infected, the agency estimates.

The drugs that fight the disease, generally work by targeting various processes that the virus uses to replicate.

The Quad pill in development is the double-drug Truvada, with evitegravir, an integrase inhibitor--similar to Merck & Co.'s (MRK) Isentress--that works by interfering with HIV's ability to integrate into the genetic material of human cells.

The fourth portion of the drug is cobicistat, a so-called boosting agent that increases the amount of evitegravir in the blood, thus allowing once-daily dosing.

The Quad is being studied in two late-stage trials that are due in the third quarter. One study tests its effectiveness versus Atripla, while another compares it to Truvada combined with Bristol-Myers Squibb's Reyataz, along with Norvir from Abbott Laboratories (ABT).

Other than convenience, the Quad pill is hoped to have fewer side effects than Atripla, which includes Bristol-Myers' Sustiva. Sustiva can cause symptoms like dizziness, insomnia and impaired concentration, and it can't be used by women of child-bearing age.

Other than convenience, the Quad pill is hoped to have fewer side effects related to Sustiva including central nervous system symptoms such as dizziness, insomnia and impaired concentration. Also, the elimination of Sustiva means that it could be taken by women of child-bearing age.

Because of those benefits, the Quad may not have to show that it works better than Atripla and could gain "significant adoption" if it demonstrated similar effectiveness, Oppenheimer & Co. analyst Bret Holley said recently in a note to clients.

Aside from the Quad, Gilead is seeking approval of a follow-up to Atripla, commonly called "B-tripla," that is a combination of Truvada and TMC278, an antiviral drug from Johnson & Johnson (JNJ). A decision from the Food and Drug Administration is expected in August.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com

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