Genelabs Technologies, Inc. (NASDAQ:GNLB)
Industry: Healthcare
Genelabs Technologies, Inc. (Genelabs), incorporated in 1985, is a biopharmaceutical company engaged in the discovery and development of pharmaceutical products. In the Company's drug discovery programs, which are concentrated on new treatments for infection with the hepatitis C virus (HCV), it seeks to identify compounds that have an advantage over potential compounds in potency, safety, and/or pharmacokinetic properties. The Company has also two separate development-stage projects: Prestara (prasterone), an investigational drug for systemic lupus erythematosus (SLE) or lupus, and an investigational vaccine for hepatitis E virus (HEV), which is being developed by GlaxoSmithKline under a license from Genelabs. Genelabs initiated work on two projects directed at inhibiting HCV infections by targeting the viral specific enzyme, HCV RNA-dependent RNA polymerase, also known as NS5b or HCV polymerase. During the year ended December 31, 2005, Genelabs continued drug discovery and development work on compounds from both projects and discovered a new class of non-nucleoside compounds that demonstrated a larger level of potency in cell-based models than a preclinical development compound that it identified earlier. The Company conducts its work in the nucleoside program under a research collaboration and license agreement with Gilead Sciences, Inc. that it entered into during the year ended December 31, 2004. Genelabs is conducting discovery and preclinical development activities on its HCV non-nucleoside polymerase project. In 2005, the Company initiated a project to screen and optimize compounds directed against another HCV target, NS5a. In September 2004, the Company signed an agreement with Gilead Sciences, Inc. to collaborate in the research, development and commercialization of nucleoside inhibitors of the HCV polymerase. The Company has granted licenses to third parties under its intellectual property portfolio, including under patents covering the hepatitis E virus, hepatitis G virus and a nucleic acid amplification technology known as LADA. The Company's HCV programs have focused on different mechanisms of inhibiting the replication of the HCV virus. Two of these approaches target a viral-specific enzyme, which is called the HCV NS5b RNA-dependent RNA polymerase. This enzyme is directly involved in HCV replication. Development of Prestara for Systemic Lupus Erythematosus The clinical development efforts have been concentrated on Prestara (prasterone), an investigational drug for systemic lupus erythematosus. Prestara is a pharmaceutical formulation for oral administration that contains highly purified prasterone, the synthetic equivalent of dehydroepiandrosterone (DHEA), a naturally occurring hormone and the most abundant adrenal hormone in humans, as the active ingredient. Genelabs obtained a license to the rights to Prestara for use in SLE from Stanford University, and has completed three double-blind randomized placebo controlled clinical trials of Prestara in women with lupus. The Company has pursued regulatory approval of an investigational drug for women with systemic lupus erythematosus. Although the most recent of Genelabs' Phase III clinical trials of Prestara did not meet its primary endpoint, the United States Food and Drug Administration (FDA) has indicated that they may review a New Drug Application (NDA), for treating the signs and symptoms of lupus based on an additional, positive phase III clinical trial that meets their criteria. Genelabs licensed rights to Prestara for North America to Watson Pharmaceuticals, Inc. Genelabs holds approximately 8% of the equity in Genovate Biotechnology Co., Ltd., a Taiwan-based company. Genovate develops, manufactures and distributes pharmaceutical products in Asia and holds the rights to market Prestara in Asia (except Japan), Australia and New Zealand. In addition to its clinical trials, Genovate has conducted two Phase III clinical trials of prasterone in Taiwan. Hepatitis E Vaccine Genelabs granted GlaxoSmithKline (GSK) a worldwide royalty-be
As Of: 10/07 00:00 ET
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