Pharmaceutical Update

The Food and Drug Administration was due by March 16 to have decided on the marketing application for Roche and Trimeris's experimental HIV entry inhibitor Fuzeon. (No information was available about the expected approval at press time.) Fuzeon is the first anti-HIV drug to be developed in the entry inhibitor class. The Department of Health and Human Services gave approval in January for OraSure Technologies to more widely distribute its OraQuick Rapid HIV-1 Antibody Test to more than 100,000 sites nationwide, including physicians' offices and HIV counseling centers. The test, which can provide results in about 20 minutes, was approved by the Food and Drug Administration in November. Two four-month studies show that Bio-Technology General Corp.'s anabolic steroid oxandrolone, when combined with exercise and proper nutrition, increases weight and lean body tissue in patients suffering from HIV- or cancer-related wasting. Pharmacia Corp. announced in January that it will allow generic-drug makers to manufacture cheap copies of its HIV nonnucleoside reverse transcriptase inhibitor Rescriptor to sell in 78 developing nations. Two new studies show that Agouron's protease inhibitor Viracept does not increase the risk of birth defects in infants of pregnant women who take the anti-HIV medication and that taking the drug with a moderate-calorie, low-fat meal or a high-calorie, high-fat meal results in blood levels of the drug three to five times higher than achieved when taking it without food. Meanwhile, Roche, the distributor of the drug outside the United States, announced in February that it will slash the cost of Viracept to 'no-profit' prices in sub-Saharan Africa and other poor nations. A year's supply will cost about $800 to $900. Boehringer Ingelheim announced in February the launch of two Phase III clinical trials of its experimental second-generation, nonpeptidic protease inhibitor tipranivir. The trials include 1,500 people at more than 280 sites worldwide. Vertex Pharmaceuticals and GlaxoSmithKline report that a human trial of their once- or twice-daily experimental protease inhibitor GW433908 shows the drug reduced blood-based virus to undetectable levels in 66% of patients previously untreated for HIV disease. A new study shows that Gilead Sciences' experimental nucleoside reverse transcriptase inhibitor Coviracil is effective in suppressing HIV to undetectable levels when taken as part of a once-daily, protease inhibitor'sparing regimen. Auxilium announced on February 4 the launch of Testim, a testosterone gel that can be used in hormone replacement therapy for HIV-positive men with low testosterone levels. Data from a 50-patient study of Tibotec's experimental protease inhibitor TMC114 show that the drug has significant antiviral activity in multiple protease inhibitor'experienced patients currently on failing drug regimens. Roche Pharmaceuticals and Trimeris report that preliminary data from a human trial of their experimental entry inhibitor T-1249 show the compound is effective in suppressing HIV resistant to Fuzeon, the companies' other experimental entry inhibitor. Kucera Pharmaceutical has announced that the company is developing a new synthetic molecule, called KPC-2, that was shown in early tests to prevent HIV replication. The company plans to seek FDA approval to begin clinical trials. Data from a Phase I trial of Indevus (formerly Interneuron) Pharmaceuticals' experimental vaginal microbicide gel PRO 2000 show that the compound is safe and was well tolerated by both sexually active HIV-negative women and HIV-positive, abstinent women. Data from a 96-week clinical trial show that treatment-naive patients taking Gilead Sciences' nucleotide reverse transcriptase inhibitor Viread experience less lipodystrophy and have lower elevations in fasting cholesterol and triglycerides than study subjects taking d4T.