Pharmaceutical Update

Bristol-Myers Squibb's Zerit XR, a once-daily, extended release form of the nucleoside reverse transcriptase inhibitor Zerit (d4T), was approved by the Food and Drug Administration on December 31. The FDA in November approved Eli Lilly's Forteo, the first drug for the treatment of osteoporosis that stimulates bone development. Osteoporosis has been associated with the use of HIV antiretroviral therapy. Bristol-Myers Squibb filed for FDA approval on December 20 of its second-generation protease inhibitor atazanavir. GlaxoSmithKline and Vertex Pharmaceuticals filed on December 20 for FDA approval of their second-generation protease inhibitor GW433908. VaxGen's announced on December 16 its experimental HIV vaccine AIDSVAX was granted fast-track review status by the FDA. The company says it will have data from two Phase III trials to submit to the FDA by the end of the first quarter of 2003. The FDA proposed a new label warning on January 16 for over-the-counter contraceptives, including condoms, that contain the spermicide nonoxynol-9, warning that the substance does not provide protection against HIV or other sexually transmitted diseases and may actually make infection easier. Supplies of the HIV fusion inhibitor Fuzeon, currently under review by the FDA, are expected to be low this year, with enough of the drug available to treat only about 12,000 to 15,000 patients, officials at Roche and Trimeris have announced. FDA approval of the injectable drug is expected in March. The FDA approved Roche Diagnostics' COBAS AmpliScreen HIV-1 Test, version 1.5, in December for the detection of HIV RNA in blood plasma. The company also recently received FDA approval of a screening system for the blood banking industry and a test that detects hepatitis C virus in the blood. The FDA on December 10 OK'd marketing of the ViroSeq HIV-1 Genotyping System, developed by Celera Diagnostics, for the detection of HIV mutations that convey resistance to anti-HIV medications. The tests will be manufactured by Celera and distributed by Abbott Diagnostics. Gilead Science's anti-HIV drug Viread has been shown to have a potent effect against chronic hepatitis B virus in patients coinfected with HBV and HIV, according to a study at St. Louis's Washington University School of Medicine. GlaxoSmithKline purchased the rights in January to produce and market ONO-4128, a drug that aims to block the CCR5 receptors on CD4 cells and macrophages that HIV binds to during the infection process, from the Japanese firm Ono Pharmaceutical Co. The National Institutes of Health awarded an $8 million grant in January to the University of Pittsburgh and Magee-Womens Research Institute to study microbicide UC781 that has shown promise in blocking HIV infection. Researchers at the National Institutes of Health reported that the antiviral drug cidofovir does not have a therapeutic benefit to patients with Kaposi's sarcoma lesions, despite earlier lab studies that showed the drug had activity against Kaposi sarcoma-associated herpes virus. Cidofovir, marketed by Gilead Sciences, is commonly used to treat AIDS-related cytomegalovirus retinitis. Chiron announced on January 14 that it would continue providing some funding for a study on using the anticancer drug interleukin-2 as an immune system booster, reversing an October 2002 decision to stop all support. Gilead Sciences announced December 4 that it acquired Triangle Pharmaceuticals for $464 million. The deal gives Gilead ownership of Triangle's experimental nucleoside reverse transcriptase inhibitor Coviracil, which was submitted for FDA approval in September.