J&J Wins FDA Approval for First New AIDS Drug in Three Years

Johnson & Johnson won U.S. regulatory approval for its Edurant pill, the first new AIDS treatment in three years.

The medicine from New Brunswick, New Jersey-based J&J was approved for patients starting their first HIV therapy, the Food and Drug Administration said in a statement today. The move clears a hurdle for a planned combination pill with Gilead Science Inc.’s Truvada that may generate more than $1 billion in annual sales, said Courtney Stanton, an analyst at Decision Resources Inc. in Burlington, Massachusetts.

Edurant stirred excitement among investors who said its pairing with Truvada might outstrip Gilead’s Atripla, the top-selling AIDS medicine with $2.93 billion in revenue last year. While studies showing J&J’s drug is less effective have dimmed those hopes, the once-daily pill may still find a niche among patients who don’t respond to Atripla or can’t tolerate its side effects, Stanton said.

J&J’s drug “will still be a blockbuster, but not quite the blockbuster that they were hoping for,” Stanton said in a telephone interview before today’s announcement. “There’s definitely going to be people that are excited about it and people that are running out of other options who are going to take it.”

J&J, the world’s second-biggest seller of health products after Pfizer Inc., fell 70 cents, or 1.1 percent, to $65.69 at 4 p.m. in New York Stock Exchange composite trading. Gilead, based in Foster City, California, rose 80 cents, or 2 percent, to $40.98 in Nasdaq Stock Market composite trading.

August Decision

The FDA may rule on the combination treatment by August, Gilead Chief Operating Officer John Milligan told investors at a May 3 conference. J&J will sell the drug, formerly called TMC278, to Gilead and also as a stand-alone treatment, Stanton said. The medicine may generate $870 million for J&J in 2015, according to a note today to clients from Larry Biegelsen, a Wells Fargo & Co. analyst in New York.

The drug is made by J&J’s Cork, Ireland-based Tibotec Pharmaceuticals unit. The last AIDS drug approved by the FDA was Tibotec’s Intelence, in 2008.

The AIDS virus infects 56,000 Americans each year, according to the U.S. Centers for Disease Control and Prevention. There were 2.6 million new infections worldwide in 2009, with more than 33 million people living with the virus, according to United Nations’ UNAIDS program.

Atripla combines Truvada with Sustiva, made by New York-based Bristol-Myers Squibb Co.

Side Effects

J&J’s drug, also known as rilpivirine, hasn’t shown the side effects associated with Sustiva, among them heightened risks of depression, suicide or birth defects, Stanton said. It also hasn’t proven as effective, she said. Nine percent of patients developed resistance to TMC278 in study results released last July, compared with 5 percent on Sustiva.

“In the grand scheme of things, 9 percent is still pretty low,” Stanton said. “But Atripla is such a powerhouse in this space, that it’s going to be hard to displace.”

Edurant was approved after two 48-week studies of a combined 1,400 patients that found it lowered the AIDS virus to undetectable levels in 83 percent of patients, compared with 80 percent for Sustiva, according to a statement from J&J. Two percent of Edurant patients quit due to side effects, half the rate for Sustiva, the company said.

“The complexity of HIV care can be especially challenging for people who have never before been treated, so the goal is to find a regimen that is effective and tolerable,” Calvin J. Cohen, lead scientist on the Edurant studies, said in the statement. “Edurant may provide a welcome new option,” he said.

Cohen is research director at the Community Research Initiative of New England, a Boston-based nonprofit that promotes AIDS studies.

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