<< GILEAD top takeover biotech, top pipeline 41 minutes ago Gilead’s Experimental AIDS Drug Outperforms Rival, Study Shows By Ryan Flinn (Bloomberg) - Sep 19, 2011 5:34 PM ET
Gilead said 90 percent of the patients taking its four-drug cocktail, called Quad, responded positively to the treatment compared with 87 percent taking a combination of approved therapies, the Foster City, California-based company said today in a statement. The drug is in the final stage of clinical trials generally required for regulatory approval.
“The 90 percent response rate observed on the Quad arm in this study is an unprecedented result,” Norbert Bischofberger, Gilead’s chief scientific officer, said in a statement. “We are now working toward filing for U.S. regulatory approval of the Quad by the end of the year.”
The pill’s development is a way for Gilead, the world’s biggest AIDS-drug maker, to expand revenue and offer patients a medicine with fewer side effects that’s more convenient than current treatments, the company has said. Gilead generated $6.3 billion from HIV drugs in 2010, capturing more than 40 percent of the market.
Atripla, a three-drug combination pill approved in 2006, is the most widely used AIDS medicine. The therapy mixes Gilead’s two-drug medicine Truvada, approved in 2004, with Bristol-Myers Squibb Co. (BMY)’s pill Sustiva. Quad contains four Gilead compounds in a single pill that patients take once a day.
‘Key Growth Driver’
“Quad is a key growth driver for converting patients from Atripla,” and rival medicines, said Michael Yee, director of biotechnology equity research with RBC Capital Markets in San Francisco.
Gilead declined 36 cents to $40.05 at 4 p.m. New York time in Nasdaq Stock Market composite trading before the statement was released.
The therapy was tested on patients with HIV, the virus that causes AIDS who aren’t taking other medications. The treatment met its primary objective last month, when the medicine proved to be at least as effective as Atripla. In both cases, the results didn’t show the medicine was statistically superior.
“Overall, it’s positive, but they won’t be able to make the claims that we thought they might have had a chance to make,” said Geoffrey Porges, an analyst at Sanford C. Bernstein & Co. in an interview. “There will be some initial disappointment around that.”
Worldwide Infections The number of people with HIV continues to grow. Each year, 56,000 Americans are infected with the virus, particularly gay men and minorities, according to the U.S. Centers for Disease Control and Prevention. There were 2.6 million new infections globally in 2009, with more than 33 million people living with the virus, according to UNAIDS.
Brad Hare, the medical director of the University of California, San Francisco, Positive Health Program, said about 30 percent of HIV/AIDS patients suffer side effects from Atripla, can’t take the therapy because it causes birth defects, or have grown resistant to it. Quad would offer another option for those patients, he said in an interview.
“With those three things -- side effects, birth defects, and transmitted resistance, there’s a good chunk of people who wouldn’t be able to take Atripla,” Hare said. The quad pill, if approved, “gives us the flexibility and options to choose among multiple convenient regimens to individualize a patient’s treatment to their particular situation.”
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