HIV franchise, new drugs give Gilead momentum

LOS ANGELES (Reuters) - Gilead Sciences Inc (GILD.O) expects strong sales growth following recent data showing the superiority of its HIV drugs to a competing regimen, its president and chief operation officer told Reuters on Wednesday.

Growth for the biotechnology company will also come from this week's U.S. regulatory approval of HIV drug Viread for treating hepatitis B and the expected approval next month of an experimental treatment for cystic fibrosis, COO John Milligan said in an interview.

The company, known mainly for its HIV franchise, has in recent years expanded its focus to include hepatitis, cardiovascular and respiratory treatments.

A study presented last week at the World AIDS Congress showed Gilead's Truvada could be more effective at controlling the virus that causes AIDS than GlaxoSmithKline Plc's (GSK.L) Epzicom, a combination of AIDS drugs Ziagen and Epivir.

Truvada is a pill combining Gilead's Viread and Emtriva, also known as tenofovir and emtricitabine.

Another study at the AIDS Congress in Mexico City linked treatment with Ziagen, known generically as abacavir, to a higher risk of heart attack and other cardiovascular events.

"There are a lot of chinks in the armor for Epzicom," Milligan said.

Analysts have estimated that the Glaxo drug holds about a 20 percent share of the U.S. HIV treatment market.

Milligan said cardiovascular data on Viread would likely be unveiled next year, and the expectation is that the Gilead drug will not be linked to a greater risk of heart attack.

He said Gilead's HIV drug sales will also increase as more patients are diagnosed and kept alive by treatment regimens.

PATIENTS WITH HEPATITIS B UNDERSERVED

Unlike HIV patients, most people infected with hepatitis B are not being treated with antiviral drugs, making that market a good fit with Viread, Milligan said.

"This opens up the opportunity to treat for a longer period of time without side effects," he said.

The COO expects Viread to eventually replace Gilead's older drug Hepsera as a treatment for hepatitis B, although he declined to comment on a specific timeframe.

"All our marketing efforts will go to Viread going forward," he said, noting because the drug has been available for years as an HIV treatment it has a strong safety record compared with newer rivals such as Bristol-Myers Squibb Co's (BMY.N) Baraclude.

Hepsera, launched in 2002, had 2007 sales of $303 million.

The U.S. Food and Drug Administration is slated to decide by mid-September on the company's application to sell astreonam lysine as a treatment for lung infections associated with cystic fibrosis.

Milligan expects Gilead's drug to eventually replace TOBI, an inhaled antibiotic sold by Novartis AG (NOVN.VX). That would give astreonam lysine a market potential of at least $250 million a year, he said. Gilead is conducting a head-to-head trial of the two cystic fibrosis treatments.

The company also expects to have key data starting later this year through 2009 on drugs in its cardiovascular pipeline as well as HIV products.

"We have an awful lot of things going well with discovery, so I don't think we need to do something," he said, referring to further acquisitions.

Milligan did note that Gilead is always willing to license a product candidate if something were to emerge.

He said Gilead "is a little ahead of where people had expected" in buying shares under a $3 billion repurchase plan.

"It made more sense to buy more stock now. We have an awful lot of momentum going forward," he said.

(Editing by Braden Reddall)