Two AIDS Drug Combinations Approved

U.S. regulators on Monday said they approved two AIDS drug combinations designed to simplify treatment for patients in the United States and in poor countries grappling with the epidemic.

U.S. regulators on Monday said they approved two AIDS drug combinations designed to simplify treatment for patients in the United States and in poor countries grappling with the epidemic.Makers GlaxoSmithKline Plc and Gilead Sciences Inc. said they intended to provide the medicines at “no-profit” prices for needy nations.Glaxo also said it would give a free, 60-day supply of its combination drug, called Epzicom, to U.S. patients.Proponents of aggressively treating AIDS around the world consider the easier-to-take combination pills vital to fighting the disease in Africa and the Caribbean.The medicines “will be especially useful in our efforts to speed the availability of safe and effective fixed-dose combination products to those who need them in this country and in developing countries,” Acting Food and Drug Administration Commissioner Lester Crawford said.U.S. officials will consider purchasing the new drugs as part of President Bush’s $15 billion anti-AIDS effort, a spokeswoman for the Office of the Global AIDS Coordinator said.More applications for combination pills are expected, including one from Indian generic drug maker Ranbaxy Laboratories Ltd.”We want to buy the cheapest drugs we can that we know are of a high quality,” the AIDS coordinator’s spokeswoman said.The new combinations pair two medicines into one tablet, making treatment regimens easier to follow. Older therapies made patients juggle multiple pills and doses.Glaxo’s Epzicom combines the company’s HIV medicines Epivir and Ziagen into a once-a-day pill. Gilead’s once-a-day tablet, called Truvada, contains the AIDS-fighting drugs Viread and Emtriva.The drugs were approved for use with other HIV-fighting drugs from different classes. Controlling the disease generally takes three or more drugs of different classes taken at the same time, the FDA said.The Bush administration had resisted spending U.S. money on HIV-fighting drug combinations, arguing they had not been proven safe and effective.Under pressure from AIDS activists and some lawmakers, health officials set up an approval process to certify that the combination drugs met U.S. standards.The HIV virus that causes AIDS infects 43 million people worldwide and has killed more than 25 million. There is no cure, but drug cocktails can control the virus and keep patients relatively healthy.Geoff Porges, an analyst at Sanford Bernstein, said Gilead’s drug was seen as lagging behind Glaxo’s by at least a month, which would have given Glaxo a head start in marketing its version.”The fact that approval has come the same day is good for patients, good for the company and it’s good for the Gilead stock,” Porges said.Gilead shares, however, fell 1.76 percent to close at $63.50 on Nasdaq. Shares of giant London-based GlaxoSmithKline, gained 26 cents to close at $41.21 on the New York Stock Exchange. (Source: Reuters, August, 2004)