http://www.businessweek.com/news/2012-05-11/gilead-s-hiv-quad-pill-wins-backing-from-fda-advisers

Bloomberg News

Gilead’s HIV Quad Pill Wins Backing From FDA Advisers

May 11, 2012

Gilead Sciences Inc. (GILD:US)’s experimental HIV pill Quad, the new medicine from the world’s largest maker of AIDS drugs, gained a U.S. advisory panel’s backing to treat patients infected with the virus.

The committee voted 13-1 in favor of approving the drug, a four-in-one combination pill from Foster City, California-based Gilead. Panel members said patients taking the medicine should undergo extra testing to monitor for kidney complications.

The medicine is designed to have fewer side effects than current treatments. Approval of the Quad pill is crucial for Gilead and may generate $4 billion in peak annual sales, said Robyn Karnauskas, an analyst with Deutsche Bank AG in New York. The drugmaker is facing the loss of half of its revenue (GILD:US) from patent expirations on AIDS therapies starting in 2018.

“A once-a-day pill, depending on people’s lifestyle, that doesn’t have neuropsychiatric side effects could be very appealing,” said Demetre Daskalakis, an assistant professor at New York University School of Medicine’s infectious disease division. “I feel like people would pick the Quad as a first- line treatment.”

Gilead rose 1.2 percent to $51.84 at the close in New York. The stock has gained (GILD:US) 27 percent in the past 12 months.

The FDA is scheduled to decide by Aug. 27 whether to approve Quad for U.S. sale. The agency doesn’t have to follow the advice of its advisers.

Side Effects

Gilead’s three-drug pill Atripla, approved in 2006, is the top-selling (GILD:US) AIDS medicine. The therapy mixes Gilead’s two-drug medicine Truvada, approved in 2004, with Bristol-Myers Squibb Co. (BMY:US)’s Sustiva. Quad contains four Gilead compounds in a single pill that patients take once a day. Patients taking the drugs were less likely to have abnormal dreams, trouble sleeping, dizziness, or rash compared to an older combination of AIDS drugs, Gilead’s studies found.

“With HIV it is all about compliance if you have a drug with fewer side effects that is one pill once a day that is going to win out,” Karnauskas said.

An FDA review of studies funded by Gilead found a higher number of kidney complications reported in people taking Quad compared with other HIV treatments. Those side effects included four cases of kidney failure and one case of a rare syndrome where substances aren’t absorbed into the blood stream by the kidneys.

Taking Medication

Still, there were fewer patients who stopped taking Quad early because of side effects and the incidence of side effects was similar to other drugs, the FDA said.

“Quad has a potential to fulfill an unmet medical need with patients with HIV infection,” Andrew Cheng, Gilead’s senior vice president for clinical research and development operations, told the panel. “The Quad does not come without risk.”

Company-sponsored studies have shown Quad works as well as Atripla. Eighty-eight percent of patients in a 48-week study who took Quad had no detectable levels of HIV in their blood compared with 84 percent of those taking Atripla, according to research presented in March at the Conference on Retroviruses and Opportunistic Infections in Seattle.

To contact the reporters on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net; Shannon Pettypiece in New York at spettypiece@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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